C Remedies Project

1.
FIXCARE-200 TAB:
Basic Information: Cefixime (Content of Fix Care – 200 TAB) is an antibiotic useful

for the treatment of a number of bacterial infections. It is a third
generationcephalosporin developed by Wyeth Pharmaceuticals. It is on the World Health
Organization's List of Essential Medicines, a list of the most important medication
needed in a basic health system
Contents: CEFIXIME 200 MG TAB
Indications: Urinary Track Infection, General Infection, as an antibiotic and also for
respiratory infection.
Branches: Gynecology, Urology, GP
HS Code: 30042019
3004  Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of

mixed or unmixed products for therapeutic or prophylactic uses, put up in measured
doses(including those in the form of transdermal administration systems) or in forms or
packings for retail sale
300420  Cephalosporins and their derivatives
30042019  Cephalosporins and their derivatives: Other
Export Benefits: FMS – Attach List

Duty Drawback: 2.4 %
Approximate amount of Export Country wise from India:
Commodity: 30042019 OTHER CEPHALOSPORINS AND THEIR

DERIVATIVES Unit: KGS
S.No. Country Values in Rs. Lacs Quntity in thousands
2012- 2013- %Growt 2012- 2013- %Growt

2013 2014 h 2013 2014 h
1. USA 87,645.03 107,099.3 22.20 1,848.4 2,067.8 11.87
2 8 4
2. VIETNAM SOC 8,472.15 8,423.13 -0.58 476.22 561.92 17.99
REP
3. UKRAINE 6,993.96 6,475.99 -7.41 293.27 340.65 16.16
4. FRANCE 6,567.94 6,289.50 -4.24 256.89 290.51 13.09
5. RUSSIA 6,238.46 5,760.48 -7.66 225.93 283.21 25.35
6. UNSPECIFIED 3,119.59 4,676.49 49.91 108.45 85.15 -21.48
7. MYANMAR 3,177.24 4,448.72 40.02 190.20 418.26 119.91
8. PHILIPPINES 4,949.59 4,379.00 -11.53 207.19 233.11 12.51
9. NIGERIA 2,607.54 3,280.70 25.82 212.45 237.52 11.80
10. GERMANY 7,122.07 3,079.09 -56.77 158.60 166.96 5.27
11. YEMEN REPUBLC 2,894.14 2,659.80 -8.10 297.96 289.36 -2.88
12. BELGIUM 4,487.35 2,625.74 -41.49 130.04 62.33 -52.07
13. JORDAN 1,264.85 2,222.70 75.73 114.29 349.21 205.55
14. AUSTRIA 3,349.98 2,148.85 -35.85 47.72 24.46 -48.75
15. SRI LANKA DSR 2,037.37 2,039.72 0.12 146.46 159.54 8.93
16. NETHERLAND 2,860.38 1,899.43 -33.60 208.39 190.29 -8.68
17. BRAZIL 1,598.25 1,823.74 14.11 100.34 114.02 13.63
18. UGANDA 498.72 1,725.99 246.09 29.46 91.56 210.77
19. ETHIOPIA 8,832.38 1,705.94 -80.69 317.39 147.51 -53.53
20. ALGERIA 2,346.08 1,697.59 -27.64 5.41 16.20 199.33
21. VENEZUELA 1,157.14 1,661.87 43.62 45.18 41.71 -7.67
22. AFGHANISTAN 682.18 1,569.31 130.04 55.96 148.90 166.08
TIS
23. SOUTH AFRICA 3,438.27 1,544.68 -55.07 205.10 83.74 -59.17
24. KAZAKHSTAN 1,443.28 1,515.26 4.99 46.27 42.13 -8.95
25. CANADA 4,044.17 1,502.93 -62.84 151.57 58.26 -61.56
26. MALTA 142.68 1,383.31 869.54 1.44 41.00 2,753.31
27. SUDAN 1,016.17 1,280.97 26.06 62.97 69.73 10.74
28. KENYA 1,290.20 1,229.75 -4.69 102.29 165.44 61.74
29. CAMBODIA 1,960.61 1,166.78 -40.49 128.79 133.80 3.89
30. U ARAB EMTS 369.69 1,024.04 177.00 10.29 29.52 186.93
31. TURKMENISTAN 750.81 1,019.06 35.73 61.82 157.54 154.83
32. SLOVENIA 532.13 978.23 83.83 5.23 10.24 95.94
33. UZBEKISTAN 357.74 935.89 161.61 25.91 118.36 356.75
34. TANZANIA REP 852.82 890.61 4.43 53.17 87.63 64.79
35. MALAYSIA 625.37 787.21 25.88 40.80 43.88 7.56
36. CHINA P RP 3.18 770.52 24,166.9 0.30 40.03 13,242.33
5
37. PERU 480.36 728.75 51.71 17.52 35.03 99.92
38. THAILAND 1,377.13 722.63 -47.53 103.83 35.64 -65.68
39. SPAIN 613.55 673.74 9.81 28.15 13.06 -53.61
40. NEPAL 29.70 670.55 2,158.02 0.64 57.76 8,855.81
41. GHANA 904.45 621.61 -31.27 89.14 77.25 -13.33
42. ANGOLA 7,514.01 611.83 -91.86 13.57 17.90 31.87
43. AUSTRALIA 2,567.52 572.01 -77.72 69.07 16.61 -75.95
44. IRAQ 899.73 563.11 -37.41 120.33 50.87 -57.72
45. CONGO D. REP. 329.51 541.32 64.28 19.01 77.52 307.74
46. TAJIKISTAN 607.43 493.44 -18.77 56.50 65.65 16.20
47. COLOMBIA 352.88 425.81 20.67 19.34 21.02 8.70
48. FINLAND 582.29 420.16 -27.84 37.51 17.43 -53.53
49. MACEDONIA 29.18 410.69 1,307.44 0.26 13.28 5,046.12
50. NEW ZEALAND 322.76 402.40 24.67 8.96 3.03 -66.18
51. CONGO P REP 822.77 365.40 -55.59 51.94 71.31 37.30
52. ZIMBABWE 434.52 364.86 -16.03 20.92 31.44 50.24
53. DENMARK 208.66 351.58 68.49 13.10 37.62 187.10
54. U K 999.29 349.23 -65.05 42.74 13.44 -68.55
55. ITALY 852.08 347.14 -59.26 86.22 35.48 -58.85
56. GABON 253.07 324.90 28.38 6.41 23.25 262.96
57. KOREA RP 230.01 299.64 30.27 22.44 45.15 101.21
58. KYRGHYZSTAN 181.86 275.91 51.72 27.77 19.05 -31.40
59. SAUDI ARAB 220.62 253.99 15.13 14.05 19.48 38.69
60. CAMEROON 221.00 250.44 13.32 15.58 26.19 68.08
61. BURUNDI 21.61 220.88 922.31 2.62 3.60 37.25
62. CUBA 257.11 219.67 -14.56 7.69 8.63 12.22
63. CHILE 657.51 211.43 -67.84 26.33 6.75 -74.36
64. GUINEA 59.21 201.24 239.88 13.35 12.49 -6.41
65. GEORGIA 120.19 200.64 66.93 9.14 18.14 98.58
66. TURKEY 345.51 195.56 -43.40 30.76 33.97 10.42
67. ROMANIA 166.87 190.06 13.90 3.71 6.69 80.57
68. JAMAICA 69.85 174.93 150.42 6.23 6.36 1.99
69. SYRIA 27.87 155.12 456.51 1.42 18.64 1,212.68
70. AZERBAIJAN 410.63 142.67 -65.26 32.33 7.36 -77.22
71. BELARUS 126.25 140.99 11.68 3.84 4.57 19.11
72. LATVIA 277.96 137.42 -50.56 25.12 16.31 -35.07
73. DOMINIC REP 186.01 128.23 -31.06 8.99 8.03 -10.63
74. NICARAGUA 34.02 127.59 275.06 1.81 6.35 251.22
75. MALI 79.79 124.06 55.47 3.72 18.82 406.19
76. TRINIDAD 31.76 123.17 287.79 1.42 3.97 179.38
77. HONG KONG 137.21 112.95 -17.69 5.94 4.53 -23.67
78. ZAMBIA 361.46 112.29 -68.94 21.84 14.46 -33.77
79. MAURITIUS 282.00 107.60 -61.84 14.22 10.48 -26.34
80. ISRAEL 80.16 104.73 30.64 4.02 12.40 208.58
81. PORTUGAL 397.07 104.53 -73.67 17.93 9.85 -45.06
82. MADAGASCAR 31.44 102.50 226.00 1.46 10.43 614.60
83. SENEGAL 82.73 99.44 20.21 5.90 14.65 148.22
84. LIBERIA 23.42 98.95 322.59 2.27 4.20 84.73
85. MEXICO 14.54 94.54 550.19 0.63 11.76 1,751.34
86. HAITI 187.28 91.76 -51.00 13.53 17.47 29.14
87. BURKINA FASO 292.41 87.72 -70.00 15.02 5.12 -65.90
88. LITHUANIA 246.59 86.78 -64.81 8.52 2.41 -71.70
89. HONDURAS 120.19 86.57 -27.98 8.19 6.76 -17.52
90. SWITZERLAND 46.01 84.22 83.05 1.04 2.03 95.57
91. MOLDOVA 71.20 81.94 15.08 3.02 3.64 20.70
92. SINGAPORE 543.13 79.65 -85.34 25.86 8.41 -67.50
93. BENIN 291.48 78.55 -73.05 14.44 5.70 -60.52
94. NAMIBIA 329.90 77.35 -76.55 4.25 5.03 18.35
95. LEBANON 34.13 71.35 109.05 2.40 2.04 -15.00
96. MALAWI 371.84 69.23 -81.38 11.86 9.10 -23.27
97. MOZAMBIQUE 110.96 66.29 -40.26 6.51 6.40 -1.67
98. GUATEMALA 141.35 54.08 -61.74 10.79 6.05 -43.93
99. BAHARAIN IS 34.34 50.80 47.96 1.78 2.15 21.17
100 CROATIA 457.77 49.80 -89.12 6.01 4.39 -26.98
.
101 BOLIVIA 224.75 48.84 -78.27 15.98 2.25 -85.94
.
102 IRAN 558.74 46.51 -91.68 23.39 3.20 -86.32
.
103 INDONESIA 57.67 45.76 -20.66 1.67 3.12 87.05
.
104 LIBYA 53.40 45.27 -15.23 3.25 4.15 27.85
.
105 PAKISTAN IR 45.18 1.56
.
106 RWANDA 796.30 44.60 -94.40 15.15 1.55 -89.73
.
107 OMAN 39.05 44.44 13.81 1.84 1.11 -39.89
.
108 TAIWAN 152.82 42.00 -72.52 6.96 2.03 -70.81
.
109 COTE D' IVOIRE 13.25 40.53 205.98 0.35 3.11 788.86
.
110 MALDIVES 45.63 39.34 -13.80 9.34 11.79 26.25
.
111 BULGARIA 38.56 1.00
.
112 BAHAMAS 24.75 33.80 36.53 0.47 0.75 59.19
.
113 UNION OF SERBIA 6.17 32.71 429.78 0.05 0.76 1,390.20
. & MONTENEGRO
114 CYPRUS 5.64 29.64 425.75 0.41 1.94 375.49
.
115 ARMENIA 18.70 28.43 52.04 0.55 1.21 121.76
.
116 BOTSWANA 36.66 28.39 -22.55 4.19 2.00 -52.27
.
117 NIGER 3.79 27.78 632.83 0.55 15.06 2,644.08
.
118 SERBIA 27.66 0.85
.
119 GUYANA 88.31 20.94 -76.29 6.28 1.51 -75.98
.
120 EL SALVADOR 133.98 20.01 -85.06 12.64 2.03 -83.91
.
121 PARAGUAY 26.61 15.71 -40.96 1.27 0.22 -82.72
.
122 BARBADOS 145.26 15.30 -89.46 5.41 0.37 -93.11
.
123 JAPAN 18.81 15.29 -18.70 0.18 0.03 -83.05
.
124 MONGOLIA 16.89 14.69 -13.02 1.96 1.19 -39.38
.
125 BELIZE 0.10 14.35 14,907.7 0.00 0.72 14,300.00
. 4
126 KOREA DP RP 3.43 13.69 299.02 0.30 1.55 416.67
.
127 LAO PD RP 49.31 11.80 -76.06 1.07 2.35 120.04
.
128 MAURITANIA 97.10 9.89 -89.82 4.31 0.70 -83.68
.
129 PAPUA N GNA 348.82 7.58 -97.83 7.97 0.42 -94.73
.
130 NETHERLANDANT 7.34 0.50
. IL
131 BHUTAN 6.60 6.79 2.81 0.19 0.17 -12.57
.
132 FIJI IS 23.08 6.52 -71.76 1.63 1.22 -24.68
.
133 SIERRA LEONE 132.60 6.07 -95.42 7.42 0.27 -96.36
.
134 SWAZILAND 227.34 4.60 -97.98 6.17 0.65 -89.46
.
135 GAMBIA 67.74 4.05 -94.02 1.23 0.40 -67.40
.
136 GREECE 0.81 3.98 391.52 0.10 0.53 430.00
.
137 SOMALIA 3.85 0.43
.
138 C AFRI REP 20.59 3.34 -83.76 0.45 0.20 -55.36
.
139 SOLOMON IS 3.31 0.08
.
140 TOGO 62.22 3.09 -95.04 2.74 0.15 -94.50
.
141 DJIBOUTI 45.99 3.02 -93.43 2.28 0.62 -72.98
.
142 ERITREA 36.09 2.40 -93.35 6.51 0.03 -99.51
.
143 ECUADOR 115.56 2.37 -97.95 2.36 0.03 -98.94
.
144 HUNGARY 45.39 2.35 -94.82 0.27 0.07 -73.68
.
145 CHAD 701.92 2.28 -99.68 26.51 0.10 -99.62
.
146 BANGLADESH PR 83.87 1.83 -97.82 1.35 0.65 -51.82
.
147 ST LUCIA 0.23 1.32 484.98 0.01 0.07 536.36
.
148 MICRONESIA 0.85 0.05
.
149 EQUTL GUINEA 0.26 0.70 175.38 0.02 0.02 5.88
.
150 TONGA 0.67 0.06
.
151 MACAO 0.65 0.10
.
152 IRELAND 1,199.70 0.11 -99.99 156.10 0.02 -99.99
.
153 SEYCHELLES 4.06 0.05 -98.67 0.82 0.01 -99.03
.
154 ST KITT N A 0.23 0.04 -81.45 0.01 0.01 0.00
.
155 CAYMAN IS 0.03 0.01
.
156 CZECH REPUBLIC 486.72 1.27
.
157 DOMINICA 13.17 0.62
.
158 EGYPT A RP 2.45 0.05
.
159 ESTONIA 15.06 2.68
.
160 GUINEA BISSAU 9.57 0.14
.
161 GRENADA 0.08 0.00
.
162 ALBANIA 54.28 1.85
.
163 COSTA RICA 74.59 6.26
.
164 CAPE VERDE IS 14.76 0.19
.
165 TIMOR LESTE 2.73 0.02
.
166 SLOVAK REP 303.98 8.02
.
167 POLAND 213.46 7.45
.
168 LESOTHO 158.67 1.06
.
169 MOROCCO 108.02 1.03
.
170 SURINAME 6.98 0.10
.
171 SAMOA 4.48 0.20
.
221,533.8 210,431.0
Total -5.01
7 4
Approximate amount of Import Country wise to India
Commodity: 30042019 OTHER CEPHALOSPORINS AND THEIR

DERIVATIVES Unit: KGS
2012- 2013- 2012- 2013-

%Growth %Growth
2013 2014 2013 2014
1. U S A 4,331.82 4,532.70 4.64 6.85 3.26 -52.38
2. BELGIUM 878.53 696.82 -20.68 0.39 0.26 -33.42
3. SWITZERLAND 512.33 690.14 34.71 0.37 0.52 39.35
4. IRELAND 190.50 443.51 132.81 1.00 0.12 -88.00
5. SPAIN 116.88 36.38 -68.87 0.05 0.02 -63.83
6. CHINA P RP 6.84 6.53 -4.48 0.01 0.03 172.73
7. FRANCE 1.65 0.00
8. U K 1.29 0.00
9. NEW ZEALAND 0.40
10. PHILIPPINES 5.51 0.00
11. GERMANY 82.89 0.04
12. ITALY 272.50 0.22
13. NETHERLAND 31.04 0.01
14. BRAZIL 0.27
15. CANADA 0.75 0.00
16. CHILE 0.03
Total 6,429.90 6,409.41 -0.32
Major Export markets:
Countries: USA, Vietnam, Ukraine, France, Russia, Myanmar, Philippines, Nigeria,

Germany, Yemen, Belgium, Jordan, Austria, Sri Lanka
Region: USA, Far East Asia, Neighboring countries, CIS, West Europe, Middle East,
Africa
Major Competing Companies:
2. ASP-15 TAB:
Contents: ACECLOFENAC 100MG+PARA 325 MG+SERRATIOPEPTIDASE15MG
Basic Information: Aceclofenac is a phenylacetic acid derivative that inhibits synthesis

of the inflammatory cytokines interleukin-1b and tumour necrosis factor, and inhibits
prostaglandin E2 production. It increases glycosaminoglycans (GAG) synthesis, the
principal macromolecule of the extracellular matrix, which aids in repair and regeneration
of articular cartilage. Thus, aceclofenac has +ve effects on cartilage anabolism combined
with modulating effect of matrix catabolism. Paracetamol has analgesic and antipyretic
action with weak anti-inflammatory activity. It produces analgesia by increasing pain
threshold and antipyresis by acting on the hypothalamic heat-regulating centre.
Indications: Anti – Inflammation Analgesic, Anti – Pyretic (to reduce temperature).
Branches: Orthopedic, GP
HS Code: 30049069
3004  Medicaments(excluding goods of heading 3002, 3005 or 3006) consisting of

90  Other:
69  Nonsteroidal antiinflammatory, analgesics and antipyratic drugs: Other

Duty Drawback: Not available
Commodity: 30049069 OTHER NONSTEROIDAL ANTIINFLAMATORY, ANALGESTICS AND

ANTIPYRATIC DRUGS Unit: KGS
2012- 2013- 2012- 2013-

%Growth %Growth
2013 2014 2013 2014
1. USA 13,156.05 40,162.01 205.27 689.62 2,140.99 210.46
2. UKRAINE 10,897.88 11,168.90 2.49 462.09 396.75 -14.14
3. UK 9,630.00 11,157.33 15.86 1,341.08 1,673.62 24.80
4. AUSTRALIA 4,560.85 8,147.70 78.64 434.75 740.40 70.30
5. RUSSIA 6,167.87 6,772.54 9.80 781.57 746.47 -4.49
6. FRANCE 1,981.59 6,124.27 209.06 146.12 501.23 243.04
7. CANADA 1,895.45 4,301.08 126.92 70.82 195.00 175.33
8. UZBEKISTAN 1,718.16 2,940.45 71.14 87.15 149.71 71.78
9. SRI LANKA DSR 2,091.88 2,896.99 38.49 249.24 457.46 83.54
10. AFGHANISTAN TIS 2,377.17 2,845.01 19.68 490.03 503.51 2.75
11. NIGERIA 1,286.85 2,735.84 112.60 191.83 505.49 163.51
12. UNSPECIFIED 32.04 2,481.27 7,645.31 4.37 53.00 1,113.37
13. SOUTH AFRICA 1,568.82 2,409.62 53.59 143.15 212.15 48.20
14. BENIN 2,246.94 2,296.77 2.22 359.43 367.75 2.31
15. KAZAKHSTAN 1,544.33 1,688.70 9.35 77.74 83.99 8.03
16. KENYA 1,003.61 1,646.05 64.01 145.63 243.70 67.34
17. GHANA 1,607.97 1,569.73 -2.38 359.34 317.72 -11.58
18. SWEDEN 1,067.46 1,458.41 36.62 55.51 91.81 65.39
19. MYANMAR 986.01 1,403.06 42.30 160.65 218.53 36.03
20. VIETNAM SOC REP 1,029.70 1,374.60 33.50 87.96 94.05 6.92
21. TANZANIA REP 1,363.27 1,362.57 -0.05 297.21 328.02 10.37
22. NETHERLAND 304.18 1,287.22 323.18 50.91 145.86 186.53
23. ETHIOPIA 234.13 1,187.65 407.27 52.39 139.09 165.47
24. BRAZIL 499.07 1,063.01 113.00 23.63 26.17 10.72
25. NEW ZEALAND 743.80 1,026.60 38.02 31.63 38.50 21.73
26. IRAN 534.05 1,017.80 90.58 17.07 89.88 426.52
27. UGANDA 986.76 924.70 -6.29 184.40 163.98 -11.07
28. MALTA 53.30 764.27 1,333.78 0.69 99.75 14,252.66
29. GERMANY 742.10 720.77 -2.87 17.60 40.07 127.70
30. NIGER 355.15 635.17 78.84 60.19 133.95 122.55
31. BURKINA FASO 174.59 627.40 259.36 17.08 163.29 855.91
32. JORDAN 104.52 569.23 444.61 13.22 53.72 306.27
33. ANGOLA 356.13 544.28 52.83 117.86 73.63 -37.53
34. IRAQ 247.65 530.01 114.02 49.91 90.79 81.91
35. MOLDOVA 212.55 525.71 147.33 20.80 47.16 126.79
36. BELARUS 229.11 503.17 119.62 45.33 70.68 55.91
37. PHILIPPINES 256.26 490.35 91.35 15.74 24.33 54.58
38. MALAYSIA 197.77 446.13 125.59 32.28 70.55 118.51
39. JAPAN 26.26 412.21 1,469.49 0.25 1.05 328.57
40. TURKMENISTAN 390.39 385.62 -1.22 30.45 29.30 -3.78
41. YEMEN REPUBLC 178.16 381.25 113.99 30.18 56.81 88.26
42. MALAWI 238.68 353.23 47.99 27.61 38.99 41.19
43. ZAMBIA 592.56 347.79 -41.31 35.42 24.85 -29.84
44. NEPAL 338.63 338.61 -0.01 15.65 42.49 171.51
45. LIBERIA 146.66 332.99 127.04 31.64 56.93 79.95
46. LIBYA 2.70 327.69 12,046.84 2.76 37.29 1,251.09
47. CONGO D. REP. 268.16 324.27 20.92 54.13 47.47 -12.32
48. GUINEA 383.07 322.58 -15.79 97.69 73.52 -24.74
49. TAJIKISTAN 188.64 318.34 68.76 21.76 39.35 80.81
50. MOZAMBIQUE 266.36 301.12 13.05 45.82 52.71 15.02
51. GEORGIA 75.63 283.84 275.30 2.54 5.55 118.09
52. SPAIN 141.47 256.86 81.57 8.75 22.19 153.57
53. SINGAPORE 75.75 250.74 231.03 4.70 17.14 264.89
54. TURKEY 0.03 247.57 768,743.48 0.01 27.67 276,600.01
55. ZIMBABWE 73.20 247.40 237.99 8.91 22.93 157.32
56. SUDAN 192.05 239.88 24.90 30.86 36.37 17.85
57. SIERRA LEONE 444.32 236.05 -46.87 121.45 69.43 -42.83
58. THAILAND 103.48 233.42 125.58 8.09 24.05 197.34
59. CHAD 231.94 229.71 -0.96 37.15 35.87 -3.44
60. FINLAND 3.47 227.87 6,459.22 0.45 8.88 1,873.33
61. CAMEROON 144.84 222.09 53.34 30.54 48.63 59.22
62. ECUADOR 7.76 221.60 2,755.06 0.94 3.46 268.01
63. CAMBODIA 178.25 216.40 21.41 29.76 36.95 24.15
64. COLOMBIA 6.05 202.59 3,251.36 0.12 20.26 16,785.83
65. LATVIA 55.24 196.26 255.31 4.55 19.17 321.78
66. TOGO 1,006.61 190.71 -81.05 242.22 20.46 -91.55
67. HONG KONG 67.41 190.11 182.01 9.45 24.10 154.98
68. KYRGHYZSTAN 45.33 167.78 270.15 2.41 13.88 476.41
69. PERU 70.79 167.73 136.95 4.89 12.77 161.19
70. SOMALIA 108.99 166.26 52.55 21.23 33.74 58.91
71. HAITI 46.05 152.61 231.40 0.88 8.02 810.90
72. BELGIUM 633.70 143.70 -77.32 30.21 2.82 -90.65
73. U ARAB EMTS 110.40 143.00 29.53 19.77 14.33 -27.49
74. CONGO P REP 242.07 134.57 -44.41 65.35 24.58 -62.38
75. MALI 110.13 90.36 -17.95 18.47 25.37 37.34
76. HONDURAS 24.09 89.26 270.57 2.38 17.97 654.24
77. LEBANON 86.16 14.00
78. BOLIVIA 41.18 79.34 92.66 2.93 3.13 6.90
79. GUATEMALA 66.30 74.07 11.72 13.45 15.29 13.65
80. COSTA RICA 288.01 73.71 -74.41 22.49 6.77 -69.90
81. PARAGUAY 11.33 67.76 497.89 0.04 4.62 10,651.16
82. RWANDA 146.03 67.61 -53.70 6.46 9.44 46.15
83. VENEZUELA 46.67 64.34 37.86 0.75 2.09 179.55
84. IRELAND 200.54 63.88 -68.15 9.68 3.18 -67.13
85. ITALY 3.92 62.04 1,481.95 0.16 2.43 1,421.87
86. MAURITIUS 115.54 58.94 -48.99 6.01 8.64 43.83
87. OMAN 16.56 55.12 232.96 2.68 9.75 263.74
88. DOMINIC REP 107.14 52.31 -51.17 13.75 7.09 -48.40
89. CHILE 75.65 49.79 -34.19 3.82 0.84 -78.03
90. TRINIDAD 46.09 48.42 5.05 7.97 6.18 -22.36
91. MACAO 8.63 46.42 437.84 0.23 1.22 429.57
92. COTE D' IVOIRE 48.44 46.35 -4.32 2.15 2.36 9.90
93. DENMARK 56.17 43.77 -22.07 7.18 3.27 -54.53
94. GUYANA 7.29 43.02 490.35 1.64 4.82 193.30
95. LESOTHO 10.72 40.96 281.94 2.56 6.25 144.14
96. PORTUGAL 22.40 40.00 78.61 3.00 1.34 -55.33
97. CZECH REPUBLIC 50.23 38.53 -23.29 2.81 2.20 -21.72
98. MADAGASCAR 85.78 33.97 -60.40 12.93 4.09 -68.39
99. MAURITANIA 57.02 33.65 -40.99 8.57 5.60 -34.66
100. LITHUANIA 15.20 24.74 62.70 1.00 2.00 100.00
101. AZERBAIJAN 68.92 23.98 -65.21 13.02 3.83 -70.57
102. GAMBIA 27.64 23.23 -15.96 5.45 4.78 -12.15
103. JAMAICA 10.68 21.79 104.13 0.87 2.07 138.52
104. FIJI IS 17.84 21.69 21.61 4.01 4.60 14.73
105. BAHARAIN IS 34.37 21.51 -37.43 0.15 0.09 -39.61
106. NICARAGUA 9.42 19.02 101.84 1.95 3.76 92.57
107. CROATIA 16.27 18.72 15.09 1.30 1.20 -7.69
108. ROMANIA 4.49 17.16 281.89 0.62 1.00 62.34
109. TONGA 1.60 16.77 947.66 0.10 15.20 15,100.00
110. PAKISTAN IR 19.45 16.25 -16.47 0.63 0.80 27.19
111. MALDIVES 2.52 15.82 528.31 0.28 1.51 441.58
112. VANUATU REP 13.65 7.24
113. GABON 6.40 12.89 101.42 1.00 1.05 5.00
114. KOREA RP 8.88 12.80 44.10 0.10 0.15 48.51
115. BULGARIA 8.80 1.20
116. POLAND 19.36 8.61 -55.53 2.61 0.89 -65.89
117. PAPUA N GNA 33.80 7.61 -77.50 9.29 0.44 -95.26
118. MEXICO 18.67 7.59 -59.33 0.28 0.30 7.47
119. SURINAME 7.55 0.42
120. AUSTRIA 43.12 7.06 -83.64 0.72 0.01 -99.02
121. SERBIA 6.97 0.32
122. BAHAMAS 0.00 6.24 207,950.00 0.00 0.09 8,900.00
123. SOLOMON IS 6.20 0.30
124. BOTSWANA 13.42 6.05 -54.92 1.80 0.87 -51.67
125. KUWAIT 117.97 6.01 -94.91 8.30 0.35 -95.78
126. ALGERIA 702.56 5.57 -99.21 33.95 0.11 -99.68
127. MONGOLIA 5.25 0.54
128. EL SALVADOR 4.08 4.88 19.62 0.70 0.70 0.00
129. GREECE 110.38 4.56 -95.87 0.90 0.20 -77.90
130. TAIWAN 70.59 4.52 -93.60 2.88 0.20 -93.06
131. BARBADOS 5.09 4.47 -12.33 1.40 0.26 -81.21
132. BURUNDI 38.92 3.97 -89.80 4.57 0.70 -84.67
133. NAMIBIA 17.03 3.28 -80.72 1.17 1.00 -14.53
134. MOROCCO 39.29 3.07 -92.19 2.73 0.15 -94.50
135. GUAM 1.90 0.51
136. SAMOA 0.62 0.83 35.28 1.40 0.07 -95.14
137. SWAZILAND 3.21 0.27 -91.72 0.12 0.20 69.49
138. NETHERLANDANTIL 19.23 0.22 -98.84 1.73 0.04 -97.68
139. PANAMA REPUBLIC 2.50 0.45
140. ST KITT N A 0.06 0.03
141. ST LUCIA 0.19 0.05
142. SWITZERLAND 40.98 0.50
143. SYRIA 24.47 5.40
144. SENEGAL 37.30 5.55
145. SEYCHELLES 5.10 1.61
146. SLOVENIA 5.89 0.03
147. TIMOR LESTE 2.06 0.02
148. SAUDI ARAB 53.01 0.03
149. EQUTL GUINEA 2.51 0.50
150. EGYPT A RP 0.15 0.01
151. HUNGARY 353.66 13.45
152. CAPE VERDE IS 7.08 0.48
153. BHUTAN 3.15 0.20
154. ARMENIA 13.90 1.35
155. ALBANIA 33.43 1.86
Total 85,262.44 140,772.07 65.10

Approximate amount of Import Country wise to India
Not found
Major Export markets
Countries: USA, Ukraine, UK, Australia, Russia, France, Canada, Uzbekistan, Sri
Lanka, Afghanistan, Nigeria, South Africa, Benin, Kazakhstan, Kenya
Regions: North America, West Europe, CIS, Neighboring countries, Africa
3. VISCORE LS SYP
Contents: AMBROXOL 30MG + LEVOSALBUTAMOL 1 MG+ GUAIPHENESIN 50
MG
Basic Information: Ambroxol is a clinically proven systemically active moucolytic

agent. When administered orally onset of action occurs after about 30 minutes. The
breakdown of acid mucopolysaccharide fibers makes the sputum thinner and less viscous
and therefore more easily removed by coughing. Although sputum volume eventually
decreases, its viscosity remains low for as long as treatment is maintained.
Pharmacokinetics
Alteplase initiates local fibrinolysis and dissolution of clots by binding to fibrin in a
thrombus and the fibrin-bound plasminogen is converted to plasmin.
Excretion
Cleared rapidly from the plasma mainly by hepatic metabolism. Half-life: 4-5 minutes
(initial); about 40 minutes (terminal).
Ambroxol Adverse Reactions / Ambroxol Side Effects

Mind GI effects & allergic reactions
Contents: AMBROXOL 30MG + LEVOSALBUTAMOL 1 MG+ GUAIPHENESIN 50

MG
Indications: Cough and Cold
Branches: Gynecology, Pediatrics, GP
HS Code: 30049099
300490  Other
30049099  Other

Duty Drawback: -
Commodity: 30049099 OTHER MEDCNE PUT UP FOR RETAIL SALE

N.E.S Unit: KGS
%Grow 2012- 2013- %Grow

2012-2013 2013-2014
th 2013 2014 th
1. USA 692,553.7 828,084.6 19.57 16,310. 19,455. 19.28
6 5 52 86
2. SOUTH AFRICA 107,628.5 198,417.3 84.35 2,633.0 4,843.3 83.95
5 6 3 8
3. RUSSIA 80,764.08 80,041.31 -0.89 3,280.5 2,361.9 -28.00
5 9
4. KENYA 70,077.96 76,782.37 9.57 2,768.1 2,407.9 -13.01
5 0
5. UK 55,884.64 62,434.13 11.72 3,558.0 5,489.3 54.28
3 0
6. NIGERIA 52,472.96 56,984.23 8.60 4,042.2 4,795.3 18.63
6 1
7. ZAMBIA 19,701.08 55,560.87 182.02 794.29 2,089.9 163.12
1
8. TANZANIA REP 38,027.79 50,004.74 31.50 1,284.9 2,744.0 113.54
9 0
9. UGANDA 30,262.34 47,987.67 58.57 1,190.5 1,751.1 47.10
1 9
10. GHANA 56,141.32 46,168.09 -17.76 3,094.2 3,171.2 2.49
7 0
11. CANADA 31,881.57 41,182.96 29.17 815.53 1,077.4 32.11
1
12. SRI LANKA DSR 30,895.57 37,907.46 22.70 2,186.0 2,524.1 15.46
7 0
13. GERMANY 46,706.23 36,989.36 -20.80 1,927.9 1,271.1 -34.07
9 3
14. ETHIOPIA 15,020.06 36,568.94 143.47 853.71 1,313.4 53.85
7
15. VIETNAM SOC 27,327.31 36,263.41 32.70 1,202.6 1,404.4 16.77
REP 9 0
16. BRAZIL 33,577.30 33,090.45 -1.45 803.64 1,049.3 30.58
9
17. MYANMAR 22,465.71 32,790.88 45.96 1,660.6 1,870.1 12.62
5 7
18. UNSPECIFIED 6,138.44 29,545.73 381.32 94.57 491.57 419.81
19. PHILIPPINES 19,145.90 28,673.70 49.76 998.81 1,590.1 59.20
3
20. MALAWI 25,234.16 28,303.11 12.16 532.34 625.89 17.57
21. JAPAN 23,909.62 24,776.30 3.62 160.99 253.59 57.52
22. AUSTRALIA 23,028.79 24,576.59 6.72 1,190.7 1,148.5 -3.54
0 0
23. NETHERLAND 19,180.21 22,501.54 17.32 1,144.7 1,224.9 7.00
7 4
24. VENEZUELA 16,563.35 21,942.59 32.48 340.02 287.80 -15.36
25. FRANCE 18,707.79 21,177.94 13.20 1,087.6 1,204.0 10.70
4 6
26. ZIMBABWE 29,898.61 20,515.59 -31.38 991.70 551.07 -44.43
27. IRAN 14,891.06 19,839.02 33.23 531.42 461.85 -13.09
28. SLOVENIA 20,339.89 17,508.55 -13.92 180.81 170.34 -5.79
29. ANGOLA 8,500.99 17,469.38 105.50 1,933.8 1,971.3 1.94
7 5
30. BOTSWANA 13,954.67 17,043.56 22.14 407.31 408.35 0.25
31. MOZAMBIQUE 7,947.14 15,172.17 90.91 732.37 692.88 -5.39
32. THAILAND 14,726.30 14,322.03 -2.75 1,672.0 1,005.0 -39.89
8 1
33. BELGIUM 13,027.95 14,025.69 7.66 665.20 550.16 -17.29
34. UKRAINE 19,432.23 12,398.75 -36.19 1,318.3 649.37 -50.75
9
35. CAMEROON 6,333.50 12,136.34 91.62 561.95 515.07 -8.34
36. IRAQ 12,173.59 11,765.81 -3.35 964.35 3,642.4 277.71
8
37. BENIN 11,953.74 11,722.43 -1.94 1,788.9 1,343.0 -24.93
4 2
38. HUNGARY 9,147.12 11,487.78 25.59 303.45 175.60 -42.13
39. CONGO D. REP. 6,115.45 10,252.13 67.64 502.51 1,229.0 144.57
1
40. YEMEN 6,878.69 10,140.96 47.43 1,010.1 1,772.7 75.49
REPUBLC 4 3
41. MALAYSIA 7,093.54 9,305.41 31.18 402.45 426.86 6.07
42. CHILE 9,364.61 9,287.44 -0.82 745.97 639.37 -14.29
43. CAMBODIA 4,940.22 9,075.52 83.71 1,637.7 1,112.6 -32.06
5 1
44. RWANDA 5,274.90 8,958.96 69.84 181.94 187.81 3.23
45. COLOMBIA 10,634.06 8,891.37 -16.39 290.98 537.15 84.60
46. SUDAN 5,955.72 8,848.51 48.57 317.13 561.60 77.09
47. KAZAKHSTAN 8,566.42 8,788.84 2.60 483.63 191.86 -60.33
48. MAURITIUS 6,362.29 8,718.65 37.04 338.15 381.41 12.79
49. ALGERIA 6,990.44 8,475.57 21.25 246.52 142.05 -42.38
50. BURKINA FASO 6,602.24 8,286.73 25.51 234.85 436.23 85.75
51. SINGAPORE 8,193.92 8,065.20 -1.57 475.96 239.43 -49.69
52. GUINEA 4,682.58 8,041.54 71.73 622.25 903.08 45.13
53. NIGER 4,657.54 7,906.28 69.75 609.26 1,039.5 70.62
3
54. U ARAB EMTS 4,518.91 7,257.22 60.60 321.82 485.60 50.89
55. DOMINIC REP 5,787.79 7,138.46 23.34 225.63 414.31 83.63
56. NEPAL 6,565.37 7,017.53 6.89 897.20 814.67 -9.20
57. LESOTHO 5,479.46 6,818.41 24.44 134.62 145.61 8.17
58. FINLAND 4,357.09 6,712.84 54.07 134.57 190.79 41.77
59. NAMIBIA 7,858.40 6,678.66 -15.01 170.48 305.54 79.23
60. NEW ZEALAND 4,387.30 6,029.27 37.43 271.56 334.58 23.20
61. ROMANIA 6,464.86 5,849.62 -9.52 153.07 131.42 -14.14
62. PERU 3,785.22 5,669.78 49.79 180.02 211.58 17.53
63. UZBEKISTAN 4,289.60 5,527.91 28.87 361.67 475.50 31.47
64. SPAIN 5,563.67 5,422.09 -2.54 373.76 217.96 -41.69
65. IRELAND 6,503.02 5,391.93 -17.09 289.74 429.08 48.09
66. JAMAICA 3,224.90 5,373.65 66.63 141.54 160.43 13.35
67. TURKMENISTAN 2,554.22 5,132.02 100.92 296.40 896.12 202.34
68. CONGO P REP 4,795.18 4,859.18 1.33 378.55 569.36 50.41
69. AFGHANISTAN 3,590.56 4,802.71 33.76 1,235.6 716.39 -42.02
TIS 7
70. MALTA 4,624.39 4,739.99 2.50 240.15 214.20 -10.81
71. PORTUGAL 3,470.45 4,396.44 26.68 217.10 391.65 80.40
72. TAJIKISTAN 1,261.74 4,376.60 246.87 217.67 1,003.3 360.98
9
73. TOGO 3,393.99 4,324.64 27.42 417.86 311.77 -25.39
74. POLAND 5,883.06 4,301.39 -26.89 56.92 67.09 17.88
75. MOROCCO 2,848.00 4,220.51 48.19 71.84 65.72 -8.52
76. INDONESIA 1,878.31 4,098.59 118.21 343.50 516.88 50.47
77. SWAZILAND 6,849.66 4,056.04 -40.78 97.21 123.00 26.53
78. MEXICO 4,289.44 3,990.79 -6.96 150.44 135.18 -10.14
79. DENMARK 3,831.75 3,951.15 3.12 331.70 316.31 -4.64
80. HONG KONG 2,911.00 3,798.20 30.48 58.64 96.98 65.40
81. SWITZERLAND 3,019.41 3,752.81 24.29 168.06 75.26 -55.22
82. JORDAN 2,768.18 3,280.50 18.51 283.69 414.99 46.28
83. LEBANON 1,207.23 3,275.83 171.35 22.55 112.69 399.79
84. CHAD 2,265.74 3,254.05 43.62 153.97 180.82 17.44
85. BURUNDI 2,489.06 3,137.37 26.05 131.76 207.67 57.62
86. ITALY 3,861.46 3,080.80 -20.22 156.97 153.54 -2.19
87. SYRIA 1,989.47 2,985.12 50.05 56.29 1,311.6 2,230.15
6
88. CUBA 1,421.71 2,971.76 109.03 70.01 88.01 25.72
89. TURKEY 2,353.69 2,951.16 25.38 118.07 93.07 -21.17
90. KOREA RP 1,685.57 2,879.49 70.83 86.07 37.00 -57.01
91. CROATIA 2,926.87 2,866.50 -2.06 36.35 56.72 56.00
92. LIBYA 3,210.74 2,838.07 -11.61 293.09 241.72 -17.53
93. PAKISTAN IR 1,364.86 2,736.90 100.53 100.56 259.15 157.72
94. HAITI 3,327.33 2,729.73 -17.96 264.45 203.85 -22.92
95. MALDIVES 2,272.90 2,676.02 17.74 229.27 142.29 -37.94
96. PAPUA N GNA 1,699.71 2,655.24 56.22 507.83 271.15 -46.60
97. SWEDEN 1,909.81 2,643.73 38.43 84.61 162.15 91.66
98. TRINIDAD 2,049.75 2,581.34 25.93 133.08 107.03 -19.58
99. COSTA RICA 2,282.97 2,532.01 10.91 101.12 114.65 13.39
100 CZECH 3,572.13 2,511.72 -29.69 69.92 102.86 47.12
. REPUBLIC
101 MALI 2,823.88 2,481.35 -12.13 274.63 245.32 -10.67
.
102 SENEGAL 1,278.75 2,443.26 91.07 109.32 164.20 50.20
.
103 SOMALIA 1,219.63 2,442.00 100.23 412.96 424.46 2.79
.
104 LITHUANIA 1,332.39 2,418.36 81.50 49.66 76.08 53.18
.
105 ECUADOR 2,389.88 2,414.93 1.05 31.49 53.76 70.75
.
106 GUATEMALA 2,045.46 2,400.80 17.37 120.07 197.60 64.58
.
107 BELARUS 1,800.56 2,375.29 31.92 51.42 69.21 34.62
.
108 COTE D' IVOIRE 1,950.37 2,219.84 13.82 176.80 104.33 -40.99
.
109 PANAMA 2,338.05 2,122.79 -9.21 71.16 77.59 9.04
. REPUBLIC
110 BULGARIA 1,573.47 2,066.15 31.31 50.13 75.87 51.34
.
111 SIERRA LEONE 1,671.71 1,898.23 13.55 635.47 251.41 -60.44
.
112 MADAGASCAR 2,091.06 1,890.17 -9.61 296.13 186.50 -37.02
.
113 LATVIA 986.52 1,874.87 90.05 123.82 147.18 18.87
.
114 GUYANA 1,514.10 1,855.33 22.54 110.13 161.21 46.39
.
115 EL SALVADOR 1,734.62 1,836.62 5.88 115.64 152.59 31.96
.
116 ERITREA 996.78 1,813.21 81.91 78.97 94.44 19.59
.
117 GEORGIA 1,602.58 1,798.71 12.24 165.77 121.86 -26.49
.
118 AUSTRIA 2,747.78 1,771.75 -35.52 38.53 42.64 10.67
.
119 BOLIVIA 2,141.28 1,738.85 -18.79 243.16 98.77 -59.38
.
120 LIBERIA 1,622.98 1,606.53 -1.01 431.41 152.57 -64.63
.
121 GABON 1,308.66 1,569.82 19.96 46.05 32.20 -30.08
.
122 KYRGHYZSTAN 914.45 1,453.84 58.99 157.90 117.46 -25.61
.
123 OMAN 1,050.40 1,391.37 32.46 35.84 47.68 33.02
.
124 TAIWAN 758.20 1,250.84 64.98 13.65 19.49 42.73
.
125 NICARAGUA 1,540.09 1,205.88 -21.70 208.28 155.84 -25.18
.
126 C AFRI REP 1,419.97 1,146.73 -19.24 29.29 74.92 155.75
.
127 EGYPT A RP 1,173.87 1,127.16 -3.98 66.10 45.65 -30.93
.
128 CHINA P RP 747.07 1,126.88 50.84 18.09 51.68 185.69
.
129 SERBIA 1,124.10 8.47
.
130 MAURITANIA 419.18 1,027.62 145.15 58.64 131.51 124.27
.
131 UNION OF 1,483.07 1,026.94 -30.76 45.60 58.18 27.58
. SERBIA &
MONTENEGRO
132 MOLDOVA 967.09 956.49 -1.10 45.38 46.49 2.44
.
133 GAMBIA 554.55 953.30 71.91 81.77 74.10 -9.38
.
134 URUGUAY 1,361.38 952.69 -30.02 14.94 12.26 -17.96
.
135 VANUATU REP 1,062.00 952.37 -10.32 9.64 11.16 15.83
.
136 HONDURAS 2,773.69 827.07 -70.18 107.77 87.31 -18.99
.
137 ARGENTINA 651.59 820.23 25.88 5.60 11.44 104.16
.
138 AZERBAIJAN 1,451.50 791.54 -45.47 101.40 69.30 -31.66
.
139 SEYCHELLES 549.40 790.03 43.80 19.28 41.03 112.84
.
140 SAUDI ARAB 549.71 730.05 32.81 41.23 74.25 80.09
.
141 FIJI IS 702.67 633.50 -9.84 108.39 38.99 -64.03
.
142 CYPRUS 683.98 613.09 -10.36 12.05 17.41 44.44
.
143 BANGLADESH 804.09 592.66 -26.30 21.23 21.40 0.80
. PR
144 PARAGUAY 729.76 584.87 -19.85 20.48 10.71 -47.69
.
145 KOREA DP RP 521.52 478.88 -8.18 36.74 35.85 -2.41
.
146 SLOVAK REP 1,753.16 471.52 -73.10 24.36 9.35 -61.62
.
147 GUINEA BISSAU 263.05 441.41 67.80 19.11 36.00 88.35
.
148 BAHAMAS 466.69 412.48 -11.62 14.67 10.15 -30.80
.
149 BHUTAN 397.77 384.62 -3.31 35.51 108.86 206.54
.
150 NETHERLANDAN 632.14 368.88 -41.65 45.51 21.41 -52.95
. TIL
151 MONGOLIA 223.26 351.14 57.28 16.39 29.20 78.22
.
152 BAHARAIN IS 427.79 347.19 -18.84 8.98 5.73 -36.21
.
153 SURINAME 155.89 344.39 120.92 8.37 7.94 -5.15
.
154 LAO PD RP 160.52 314.96 96.21 9.63 10.87 12.89
.
155 BOSNIA- 256.97 302.82 17.84 9.72 12.46 28.16
. HRZGOVIN
156 MACEDONIA 288.32 302.51 4.92 4.23 4.11 -2.77
.
157 EQUTL GUINEA 441.60 295.74 -33.03 57.52 31.80 -44.73
.
158 KUWAIT 122.60 287.74 134.69 9.81 19.78 101.72
.
159 ISRAEL 208.76 279.19 33.74 7.45 21.08 182.81
.
160 DJIBOUTI 192.69 271.73 41.02 39.83 8.04 -79.81
.
161 ARMENIA 123.86 234.24 89.11 11.06 12.82 15.99
.
162 GREECE 822.45 216.21 -73.71 39.71 6.05 -84.76
.
163 ST LUCIA 97.19 188.31 93.75 5.26 11.35 115.78
.
164 BARBADOS 616.58 131.34 -78.70 20.61 5.82 -71.75
.
165 MICRONESIA 90.81 101.34 11.60 1.88 3.67 95.37
.
166 BELIZE 141.73 97.32 -31.34 7.51 2.83 -62.26
.
167 FR GUIANA 85.08 1.30
.
168 QATAR 164.49 85.06 -48.29 14.84 8.58 -42.23
.
169 TONGA 19.55 80.00 309.30 0.19 12.42 6,576.34
.
170 SOLOMON IS 53.16 71.91 35.29 7.39 2.09 -71.66
.
171 COMOROS 13.72 70.17 411.31 1.30 36.06 2,682.41
.
172 ANTIGUA 52.77 65.67 24.45 1.30 1.34 2.85
.
173 CAYMAN IS 19.26 63.95 232.07 0.37 2.28 521.58
.
174 SAMOA 39.63 57.12 44.15 0.99 10.35 943.85
.
175 ESTONIA 184.33 51.87 -71.86 5.84 5.30 -9.20
.
176 MACAO 73.51 51.76 -29.59 3.22 1.25 -61.20
.
177 CAPE VERDE IS 29.07 48.20 65.83 0.39 1.13 190.75
.
178 ST KITT N A 38.86 43.06 10.80 0.95 2.03 114.24
.
179 TUNISIA 204.06 34.09 -83.29 1.89 0.79 -58.28
.
180 ST VINCENT 39.96 33.06 -17.28 0.83 0.78 -6.83
.
181 NORWAY 67.76 31.29 -53.82 10.77 1.05 -90.22
.
182 GRENADA 22.56 26.43 17.16 0.88 0.99 12.12
.
183 SAO TOME 14.62 26.07 78.27 0.23 0.76 234.21
.
184 MONTENEGRO 25.56 0.33
.
185 DOMINICA 326.29 23.11 -92.92 10.05 1.06 -89.45
.
186 ALBANIA 57.26 18.76 -67.23 1.77 0.48 -72.82
.
187 LUXEMBOURG 16.91 18.51 9.50 0.09 0.16 75.56
.
188 TIMOR LESTE 311.06 17.46 -94.39 14.21 2.18 -84.65
.
189 BR VIRGN IS 0.08 13.66 17,168.1 0.02 0.16 695.00
. 4
190 PALAU 16.00 12.14 -24.09 0.14 0.11 -18.84
.
191 KIRIBATI REP 3.50 11.70 234.44 0.90 0.68 -25.00
.
192 MARSHALL 12.87 7.93 -38.35 0.33 0.25 -23.31
. ISLAND
193 ICELAND 35.73 4.61 -87.09 0.55 0.32 -42.55
.
194 PUERTO RICO 0.42 4.38 954.08 0.02 0.25 1,150.00
.
195 BRUNEI 2.30 0.06
.
196 GUAM 103.37 2.02 -98.05 3.32 0.38 -88.57
.
197 MONTSERRAT 0.64 1.84 188.79 0.00 0.05 1,700.00
.
198 NAURU RP 1.76 0.03
.
199 ANGUILLA 1.03 1.70 64.98 0.03 0.03 -12.12
.
200 GIBRALTAR 1.67 0.04
.
201 TUVALU 0.44 0.03
.
202 REUNION 0.09 0.02
.
203 PANAMA C Z 0.02 0.00
.
2,086,427. 2,560,318.
Total 22.71
98 81
Approximate amount of Import Country wise to India:

N.E.S Unit: KGS
2012- 2013-
2012-2013 2013-2014 %Growth %Growth
2013 2014
1. SWITZERLAND 42,316.70 43,137.38 1.94 43.75 57.57 31.61
2. GERMANY 26,205.81 35,640.97 36.00 21.43 97.39 354.53
3. U S A 29,105.65 32,629.05 12.11 27.80 45.67 64.27
4. ITALY 25,638.39 23,354.98 -8.91 18.00 38.91 116.19
5. U K 18,735.12 21,618.33 15.39 16.37 39.12 139.00
6. FRANCE 18,984.63 15,853.37 -16.49 18.72 24.01 28.28
7. NETHERLAND 8,196.64 10,341.38 26.17 6.83 13.94 104.07
8. BELGIUM 5,680.04 6,602.63 16.24 9.81 8.71 -11.16
9. IRELAND 8,403.77 5,705.67 -32.11 5.06 7.09 39.93
10. CANADA 2,243.56 5,163.37 130.14 2.94 12.28 317.87
11. FINLAND 2,101.45 5,086.05 142.03 1.95 20.69 963.80
12. CHINA P RP 3,585.55 4,574.38 27.58 6.53 25.94 297.15
13. SWEDEN 3,824.99 4,515.30 18.05 5.26 21.88 315.74
14. DENMARK 4,560.32 4,265.60 -6.46 4.06 4.14 1.87
15. PUERTO RICO 2,065.22 3,915.67 89.60 1.33 7.16 439.59
16. MEXICO 2,126.68 2,740.39 28.86 2.58 2.90 12.57
17. JAPAN 5,269.03 2,334.33 -55.70 5.24 2.68 -48.92
18. SPAIN 1,775.61 1,589.65 -10.47 2.91 2.99 2.92
19. AUSTRALIA 888.58 1,549.93 74.43 1.64 2.13 30.24
20. AUSTRIA 2,214.01 1,486.62 -32.85 2.61 1.65 -36.75
21. SINGAPORE 1,025.68 1,312.70 27.98 1.16 2.64 126.44
22. SOUTH AFRICA 791.27 947.76 19.78 4.91 0.80 -83.75
23. KOREA RP 989.10 785.44 -20.59 0.91 0.88 -3.07
24. MALAYSIA 2,076.59 720.81 -65.29 2.13 18.88 785.19
25. HUNGARY 126.44 634.29 401.63 0.61 0.84 39.50
26. TAIWAN 75.77 521.65 588.45 0.07 0.74 909.59
27. BRAZIL 454.66 457.00 0.52 0.49 0.36 -26.83
28. MALTA 319.27 432.33 35.41 0.58 0.32 -45.42
29. UNSPECIFIED 96.37 270.73 180.91 0.40 0.20 -49.88
30. CZECH 129.80 194.77 50.05 1.22 11.37 833.58
REPUBLIC
31. ISRAEL 405.25 188.96 -53.37 0.87 1.07 22.08
32. URUGUAY 114.54 0.11
33. TURKEY 192.09 108.00 -43.78 0.08 0.32 289.02
34. RUSSIA 3.86 95.18 2,363.20 0.00 0.08 1,400.00
35. POLAND 176.58 39.89 -77.41 0.16 0.08 -47.77
36. ARGENTINA 30.30 36.34 19.91 0.03 0.01 -75.86
37. SLOVAK REP 26.31 0.03
38. PHILIPPINES 39.95 21.95 -45.07 0.07 0.02 -72.60
39. BULGARIA 4.33 21.93 406.41 0.00 0.02 375.00
40. PORTUGAL 29.63 20.98 -29.18 0.04 0.02 -46.34
41. HONG KONG 114.69 18.48 -83.89 0.11 0.01 -90.83
42. THAILAND 6.72 14.58 116.99 0.01 0.01 0.00
43. CYPRUS 3.83 12.47 225.47 0.00 0.02 325.00
44. LITHUANIA 11.05 0.01
45. U ARAB EMTS 10.46 10.21 -2.40 0.00 0.01 20.00
46. NEW ZEALAND 7.69 6.60 -14.24 0.01 0.01 100.00
47. MALDIVES 6.03 0.01
48. CHILE 63.37 5.01 -92.09 1.04 0.00 -99.52
49. LIBERIA 4.84 0.00
50. GREECE 7.85 2.38 -69.73 0.01 0.01 -46.15
51. DOMINIC REP 1.93 0.00
52. ICELAND 15.80 1.84 -88.37 0.01 0.00 -70.00
53. SLOVENIA 21.89 1.82 -91.70 0.09 0.00 -97.73
54. AFGHANISTAN 1.37 0.01
TIS
55. INDONESIA 0.99 1.00 1.22 0.00 0.00 0.00
56. LATVIA 6.21 0.97 -84.42 0.01 0.00 -87.50
57. ROMANIA 11.08 0.79 -92.84 0.01 0.01 -53.85
58. MOROCCO 0.10 0.62 546.69 0.00 0.01 175.00
59. GEORGIA 0.42 0.00
60. KENYA 0.38 0.14 -62.49 0.00
61. CROATIA 0.05 0.02 -58.08
62. COSTA RICA 0.02
63. ALGERIA 0.54 0.00
64. BANGLADESH 0.04
PR
65. GABON 0.30
66. JORDAN 0.09
67. JAMAICA 0.69
68. KOREA DP RP 6.35 0.00
69. NAMIBIA 0.51
70. PAKISTAN IR 0.30 0.00
71. PERU 42.03 0.04
72. SAUDI ARAB 1.18 0.01
73. SRI LANKA DSR 0.30 0.00
74. SWAZILAND 57.13 0.04
75. VENEZUELA 3.37
76. ZAMBIA 1.61 0.00
77. UKRAINE 0.16
Total 221,274.41 239,159.18 8.08
Major Export Markets:
Countries: USA, South Africa, Kenya, UK, Nigeria, Zambia, Tanzania, Uganda, Ghana,
Canada, Sri Lanka, Germany, Ethiopia, Vietnam
Region: North America, Africa, Far East Asia, West Europe
4. DOXYCORE PLUS TAB & DOXYCORE OD TAB
Basic Information:
Contents of Doxycore Plus Tab: DOXYLAMINE 10MG+PYRIDOXINE 10MG +

FOLIC ACID 2.5 MG
Contents of Doxycore OD Tab: DOXYLAMINE 20MG+PYRIDOXINE 20MG+

FOLIC ACID 5MG
Indications: Nausea and vomiting during pregnancy and for morning sickness.
Branches: Gynecology, GP
HS Code: 30049039

300490 Other
30042039  Antihistaminics drugs; Antacids preparations; Antiulcer drugs; Antiemitics

and other Gastrointestinal drugs: Other

Duty Drawback: 2.4 %
Commodity: 30049039 OTHER ANTINISTANINICS
,ANTACIDS,ANTIULCER,ANTIEMITICS AND OTHER GASTOINTESTINAL
DRUGS Unit: KGS
2012- 2013- %Growt 2012- 2013- %Growt

2013 2014 h 2013 2014 h
1. USA 18,782.92 37,274.26 98.45 797.7 1,218.8 52.79
5 8
2. GERMANY 7,230.88 7,035.41 -2.70 693.9 1,049.2 51.19
5 1
3. SOUTH AFRICA 5,024.81 5,709.97 13.64 264.9 215.59 -18.63
5
4. NIGERIA 3,112.40 5,300.06 70.29 490.1 709.18 44.68
5
5. BRAZIL 2,304.72 4,521.57 96.19 93.53 127.75 36.58
6. UK 6,904.47 4,512.69 -34.64 846.2 293.41 -65.33
9
7. UNSPECIFIED 564.25 4,353.13 671.48 13.46 8.90 -33.85
8. VENEZUELA 1,999.06 4,107.90 105.49 19.08 20.04 5.04
9. MYANMAR 1,874.23 3,508.96 87.22 231.3 393.21 69.96
5
10. BELGIUM 4,990.65 3,453.89 -30.79 109.1 241.79 121.44
9
11. SRI LANKA DSR 2,409.80 3,398.22 41.02 212.6 311.33 46.44
0
12. IRELAND 2,380.91 3,198.24 34.33 179.1 275.38 53.76
0
13. AUSTRALIA 3,261.85 3,005.77 -7.85 103.0 76.15 -26.11
6
14. FRANCE 3,549.59 2,809.75 -20.84 154.5 153.76 -0.48
1
15. RUSSIA 2,803.77 2,804.37 0.02 57.49 62.85 9.32
16. VIETNAM SOC REP 2,651.71 2,725.11 2.77 170.0 160.23 -5.78
5
17. GHANA 1,878.63 2,578.56 37.26 394.4 469.82 19.10
7
18. LIBYA 1,286.67 2,413.21 87.56 129.1 216.03 67.33
0
19. INDONESIA 609.41 1,951.96 220.30 23.23 37.01 59.28
20. NETHERLAND 1,016.00 1,819.67 79.10 58.15 87.96 51.28
21. MAURITIUS 2,531.32 1,746.03 -31.02 33.39 27.92 -16.38
22. AFGHANISTAN TIS 740.34 1,364.84 84.35 130.1 212.97 63.67
2
23. SUDAN 457.97 1,041.16 127.34 29.92 36.52 22.05
24. CANADA 927.90 980.81 5.70 23.72 28.93 21.99
25. PERU 393.75 968.09 145.86 27.14 63.47 133.90
26. SPAIN 1,177.93 946.49 -19.65 144.6 181.64 25.57
5
27. HAITI 566.06 900.51 59.08 139.4 133.82 -4.01
1
28. UKRAINE 652.08 837.32 28.41 17.07 8.41 -50.76
29. TAIWAN 180.37 741.16 310.91 5.37 23.89 345.17
30. COSTA RICA 554.65 698.58 25.95 24.87 26.53 6.67
31. BENIN 284.64 668.91 135.00 37.70 112.28 197.78
32. MALAYSIA 499.18 647.66 29.75 30.22 22.94 -24.11
33. EGYPT A RP 1,107.79 640.80 -42.16 76.50 55.30 -27.71
34. KENYA 7,539.44 629.72 -91.65 99.25 45.66 -53.99
35. ECUADOR 9.04 613.31 6,681.18 0.10 5.60 5,729.17
36. MEXICO 70.48 564.09 700.41 3.69 28.57 673.10
37. NEPAL 113.55 536.16 372.16 25.20 41.21 63.49
38. BURKINA FASO 53.35 506.69 849.72 11.52 41.22 257.75
39. SINGAPORE 677.56 484.98 -28.42 37.51 15.93 -57.55
40. CAMBODIA 472.53 443.62 -6.12 62.67 56.72 -9.49
41. ROMANIA 376.13 417.04 10.87 12.68 6.57 -48.20
42. YEMEN REPUBLC 220.89 406.67 84.11 30.46 48.09 57.87
43. TANZANIA REP 385.98 405.35 5.02 44.97 33.04 -26.51
44. UZBEKISTAN 363.29 400.34 10.20 48.12 35.55 -26.12
45. ALGERIA 44.87 395.99 782.50 2.09 7.56 261.58
46. PHILIPPINES 359.86 385.91 7.24 34.80 20.93 -39.85
47. KAZAKHSTAN 851.76 359.26 -57.82 33.79 6.58 -80.54
48. NEW ZEALAND 624.82 351.82 -43.69 32.88 15.93 -51.56
49. ETHIOPIA 197.63 348.04 76.10 19.59 26.45 35.05
50. CROATIA 325.66 347.94 6.84 4.65 5.71 22.87
51. DENMARK 13.91 332.34 2,289.81 0.89 22.41 2,415.38
52. MOROCCO 140.13 332.10 137.00 1.90 2.42 27.53
53. SIERRA LEONE 285.13 289.67 1.59 44.37 61.07 37.64
54. IRAN 523.75 277.41 -47.03 12.77 15.26 19.55
55. THAILAND 162.21 267.43 64.86 18.71 42.03 124.64
56. CHINA P RP 21.22 266.73 1,156.90 0.40 5.16 1,189.50
57. HONG KONG 243.76 242.73 -0.42 15.43 14.74 -4.46
58. PANAMA 177.66 241.77 36.09 15.25 13.53 -11.30
REPUBLIC
59. KOREA DP RP 15.54 231.92 1,392.84 0.04 98.19 228,251.1
6
60. HONDURAS 173.22 229.31 32.38 25.39 22.94 -9.63
61. GEORGIA 131.80 216.40 64.20 6.36 14.10 121.81
62. JORDAN 38.22 211.40 453.15 11.19 5.16 -53.88
63. JAMAICA 69.61 202.52 190.92 5.28 7.45 41.25
64. U ARAB EMTS 96.93 187.60 93.55 3.75 3.54 -5.44
65. JAPAN 203.11 186.60 -8.13 34.35 44.43 29.33
66. ANGOLA 234.28 184.25 -21.36 33.57 12.41 -63.05
67. UGANDA 115.80 184.09 58.97 18.47 22.50 21.83
68. MALI 138.62 177.17 27.81 20.66 23.82 15.28
69. ZIMBABWE 58.79 175.57 198.67 4.35 6.06 39.23
70. AUSTRIA 174.69 2.19
71. PORTUGAL 165.80 159.60 -3.74 4.18 7.93 89.73
72. MAURITANIA 2.20 149.33 6,677.54 0.37 26.70 7,059.52
73. CHILE 224.20 148.39 -33.81 21.44 7.35 -65.71
74. GAMBIA 113.74 145.33 27.77 13.44 9.34 -30.50
75. ITALY 200.32 141.42 -29.40 6.90 8.19 18.73
76. TRINIDAD 46.90 134.82 187.44 5.08 10.25 101.99
77. BELARUS 96.17 133.15 38.45 13.02 5.35 -58.92
78. BAHARAIN IS 31.08 132.24 325.51 0.70 1.05 50.21
79. MALDIVES 151.47 117.89 -22.17 15.73 11.79 -25.00
80. GUINEA 91.68 116.94 27.56 18.05 10.05 -44.29
81. IRAQ 65.86 105.81 60.65 5.21 4.36 -16.25
82. CONGO D. REP. 40.39 102.40 153.53 19.59 12.81 -34.62
83. ZAMBIA 509.76 96.88 -81.00 37.23 14.97 -59.79
84. FINLAND 57.07 93.30 63.48 1.27 2.47 95.04
85. PAPUA N GNA 3.35 84.93 2,436.25 0.64 4.49 601.56
86. CAMEROON 20.75 83.38 301.82 3.28 13.56 313.67
87. GUATEMALA 57.01 83.09 45.74 5.11 2.89 -43.39
88. CONGO P REP 89.80 80.01 -10.90 18.68 8.88 -52.46
89. MALTA 25.86 74.22 186.97 1.40 4.66 232.57
90. LITHUANIA 25.63 59.27 131.25 3.83 3.51 -8.25
91. COLOMBIA 116.81 58.85 -49.62 5.20 21.24 308.70
92. KYRGHYZSTAN 22.45 54.42 142.39 3.56 8.47 137.70
93. MOLDOVA 22.42 51.72 130.65 4.06 1.99 -51.01
94. AZERBAIJAN 29.86 49.91 67.13 4.94 5.65 14.37
95. NETHERLANDANT 0.19 47.64 24,686.63 0.02 3.34 18,427.78
IL
96. DOMINIC REP 142.77 47.42 -66.79 28.64 3.86 -86.53
97. TAJIKISTAN 74.69 45.34 -39.29 28.71 11.45 -60.10
98. OMAN 5.25 44.25 743.07 0.78 2.33 196.68
99. HUNGARY 134.99 43.72 -67.62 17.61 2.63 -85.07
100 MOZAMBIQUE 157.60 42.33 -73.14 40.38 2.50 -93.81
.
101 BANGLADESH PR 41.40 40.18 -2.95 7.31 6.13 -16.16
.
102 LIBERIA 105.90 37.69 -64.41 15.63 26.11 67.09
.
103 SOMALIA 47.46 35.42 -25.38 11.35 3.59 -68.41
.
104 TOGO 426.10 33.21 -92.21 37.19 0.80 -97.84
.
105 BOTSWANA 7.81 30.16 285.97 0.35 0.76 116.19
.
106 MADAGASCAR 82.59 29.51 -64.27 20.96 3.87 -81.56
.
107 LEBANON 101.90 25.60 -74.88 9.34 1.80 -80.74
.
108 TURKEY 121.46 22.88 -81.16 2.47 1.58 -35.90
.
109 ARMENIA 31.09 22.14 -28.80 3.80 0.75 -80.26
.
110 RWANDA 22.15 20.69 -6.58 2.65 1.64 -38.02
.
111 MALAWI 31.98 19.37 -39.43 7.47 1.49 -80.06
.
112 SENEGAL 19.10 1.21
.
113 EL SALVADOR 1.11 17.93 1,512.55 0.10 1.00 900.00
.
114 FIJI IS 30.80 17.89 -41.91 1.99 1.45 -27.37
.
115 GUYANA 17.40 2.37
.
116 TURKMENISTAN 146.92 15.81 -89.24 19.02 2.21 -88.38
.
117 CZECH REPUBLIC 15.55 0.46
.
118 PAKISTAN IR 19.01 14.75 -22.37 3.46 4.07 17.84
.
119 BOLIVIA 47.94 13.92 -70.95 1.56 0.57 -63.39
.
120 BAHAMAS 9.21 11.50 24.89 0.64 0.50 -21.56
.
121 KOREA RP 296.80 10.85 -96.35 64.64 1.51 -97.66
.
122 KUWAIT 3.96 10.80 172.90 0.79 0.54 -30.88
.
123 NAMIBIA 25.28 10.75 -57.49 0.42 0.37 -12.26
.
124 PARAGUAY 5.89 9.53 61.89 0.25 1.60 529.92
.
125 LESOTHO 3.13 8.77 179.95 0.90 0.63 -30.56
.
126 LAO PD RP 3.02 8.53 182.70 0.41 0.32 -21.18
.
127 LATVIA 87.79 8.45 -90.37 12.21 0.35 -97.16
.
128 GABON 7.73 4.18
.
129 POLAND 18.00 7.30 -59.47 1.00 0.45 -55.30
.
130 MONGOLIA 19.24 6.40 -66.75 1.98 0.50 -74.68
.
131 CUBA 5.95 0.15
.
132 NICARAGUA 19.46 5.66 -70.92 1.44 0.70 -51.49
.
133 DOMINICA 5.50 0.09
.
134 VANUATU REP 11.16 4.41 -60.47 0.16 0.09 -43.75
.
135 SWEDEN 12.11 3.21 -73.51 0.29 0.05 -82.41
.
136 SAMOA 2.58 0.09
.
137 BURUNDI 44.58 2.25 -94.96 16.08 0.40 -97.51
.
138 CHAD 98.22 1.00 -98.98 10.20 0.10 -99.02
.
139 BELIZE 0.43 0.01
.
140 BARBADOS 15.97 0.23 -98.56 2.20 0.05 -97.95
.
141 ST KITT N A 2.67 0.09 -96.51 0.09 0.01 -86.05
.
142 ANTIGUA 0.07 0.01
.
143 NIGER 74.50 0.03 -99.96 5.58 0.02 -99.62
.
144 GRENADA 0.03 0.00
.
145 ANGUILLA 0.01 0.00
.
146 ARGENTINA 0.07 0.00
.
147 BOSNIA- 1.47 0.02
. HRZGOVIN
148 COTE D' IVOIRE 1.89 0.16
.
149 PUERTO RICO 1.21 0.10
.
150 MONACO 19.02 1.50
.
151 MACEDONIA 8.45 0.45
.
152 ST VINCENT 0.17 0.01
.
153 SURINAME 3.98 0.20
.
154 UNION OF SERBIA 36.62 1.68
. & MONTENEGRO
155 SEYCHELLES 8.19 0.51
.
156 SOLOMON IS 2.74 0.30
.
105,067.7 134,182.9
Total 27.71
7 1
Commodity: 30049039 OTHER ANTINISTANINICS
,ANTACIDS,ANTIULCER,ANTIEMITICS AND OTHER GASTOINTESTINAL
DRUGS Unit: KGS
2012- 2013- 2012- 2013-

%Growth %Growth
2013 2014 2013 2014
1. GERMANY 600.23 666.96 11.12 0.36 2.10 483.06
2. U K 560.43 0.20
3. ITALY 199.41 236.49 18.60 0.09 0.10 5.26
4. SWITZERLAND 370.18 208.09 -43.79 0.10 0.14 36.00
5. MALAYSIA 194.26 192.88 -0.71 0.15 0.08 -45.95
6. U S A 150.07 87.35 -41.80 0.07 0.08 18.84
7. SOUTH AFRICA 7.83 55.07 602.86 0.01 0.99 10,900.00
8. FRANCE 41.01 0.04
9. BRAZIL 3.31 0.00
10. MEXICO 0.80 1.00 26.30 0.00
11. CANADA 2.79 0.49 -82.30 0.00
12. IRELAND 0.07 0.17 147.43 0.00
13. VENEZUELA 0.08
14. UNSPECIFIED 9.07 0.01
Total 1,542.08 2,053.33 33.15
Countries: USA, Germany, South Africa, Nigeria, Brazil, UK, Venezuela, Myanmar,
Belgium, Sri Lanka, Ireland, Australia, France, Russia
Region: USA, Europe, Africa, Neighboring countries Europe, CIS, Australia
5. HCT OD TAB & BIOLATE M TAB
Contents of HCT OD TAB: METHYLCOBALAMIN 1500MG + PYRIDOXINE 20

MG+FOLIC ACID 5MG
Contents of Biolate M Tab: L-METHYLFOLATE 1MG+BIOTIN 5 MG+ PYRIDOXAL 5

PHOSPHATE 2.5MG+ METHYLCOBALAMIN 1500MCG
Basic Information: Methylcobalamin is a cobalamin (MeB12) used in peripheral

neuropathy, diabetic neuropathy etc. It is a form of vitamin B12. This vitamer is one of
two active coenzymes used by B-12 dependent enzymes in the body, and is specifically
the B-12 form used by 5-methyltetrahydrofolate-homocysteine methyltransferase (MTR),
also known as methionine synthase.

Methylcobalamin is notable for being one of the few examples in nature of a bona fide
organometallic bond. Methylcobalamin has been studied in conjunction with sleep-wake
rhythm disorders, where it appears to yield benefits, but at a low or inconsistent level. It
is used in treating diseases of vitamin B12 deficiency (such as pernicious anemia), or
diseases of effective B12 deficiency, such as vitamin B12 metabolic pathway
pathologies. One study suggests that once absorbed, methylcobalamin may be retained in
the body better than cyanocobalamin.
Indications: Multi Vitamin, Neuropathy, Supplementation for Neuron
Branches: Gynecology, Neurology, GP

HS Code: 30045010

doses (including those in the form of transdermal administration systems) or in forms or
300450  Other medicaments containing vitamins or other products of heading 2936:

Heamatinics and Erythropoyetin preparations
Export Benefits: Focus Market Scheme – Refer FMS list (Common for all products)
Duty Drawback: - 0 %
Commodity: 30045010 HEAMATINICS AND ERYTHROPOIETIN Unit: KGS

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. NIGERIA 2,991.69 2,514.49 -15.95 466.13 375.01 -19.55
2. ALGERIA 1,839.13 793.88 -56.83 9.80 6.72 -31.42
3. SRI LANKA DSR 521.29 385.53 -26.04 67.37 39.91 -40.76
4. KENYA 47.70 243.61 410.73 6.48 27.77 328.42
5. LEBANON 67.32 170.08 152.64 0.44 0.74 68.41
6. BENIN 50.19 128.17 155.35 5.45 25.00 358.55
7. MYANMAR 155.96 115.96 -25.65 18.02 15.52 -13.89
8. NEPAL 7.71 94.09 1,120.49 0.03 9.66 33,210.35
9. VIETNAM SOC REP 138.57 84.77 -38.82 10.30 10.91 5.97
10. YEMEN REPUBLC 115.30 78.61 -31.82 11.61 10.20 -12.18
11. SURINAME 19.15 61.22 219.77 0.26 3.00 1,067.32
12. TANZANIA REP 203.37 60.25 -70.37 17.68 3.84 -78.31
13. URUGUAY 43.15 53.62 24.25 0.26 0.31 19.14
14. LATVIA 21.27 47.21 121.93 7.99 3.58 -55.17
15. AUSTRALIA 2.22 43.66 1,866.86 0.04 1.40 3,155.81
16. ZAMBIA 35.15 42.56 21.09 3.30 3.13 -5.24
17. TAJIKISTAN 17.66 42.08 138.32 0.74 5.00 574.76
18. CANADA 16.79 42.08 150.57 0.37 1.06 185.71
19. MAURITIUS 25.95 41.69 60.69 1.68 3.60 114.03
20. RUSSIA 43.13 41.56 -3.63 4.02 0.58 -85.45
21. BARBADOS 14.43 41.40 186.80 1.30 3.35 157.69
22. AFGHANISTAN TIS 39.77 41.39 4.06 20.71 5.20 -74.87
24. SIERRA LEONE 48.89 34.18 -30.08 8.24 6.03 -26.86
25. IRAQ 33.52 8.24
26. SINGAPORE 27.54 30.70 11.46 1.31 2.17 66.16
27. GHANA 140.44 30.20 -78.50 14.22 4.80 -66.23
28. SOUTH AFRICA 56.97 28.11 -50.66 3.21 3.20 -0.37
29. UZBEKISTAN 1.37 27.89 1,931.26 0.04 4.00 9,900.00
30. JAMAICA 62.08 27.48 -55.73 1.05 0.62 -40.84
31. VENEZUELA 11.08 23.31 110.32 0.60 1.33 122.04
32. OMAN 11.79 22.05 87.03 0.22 0.65 202.33
33. MALAYSIA 14.33 20.58 43.61 1.37 2.17 58.86
34. KYRGHYZSTAN 3.78 20.56 444.39 0.13 0.66 428.00
35. ANGOLA 19.90 1.50
36. CONGO P REP 2.40 19.79 723.68 3.44 1.91 -44.56
37. FRANCE 11.69 19.72 68.66 0.50 2.91 482.20
38. ZIMBABWE 6.15 18.27 197.11 0.61 0.92 50.33
39. PHILIPPINES 40.66 17.39 -57.24 1.64 1.71 4.27
40. U K 3.63 17.00 368.22 0.22 0.93 316.67
41. CAMEROON 25.16 15.75 -37.43 2.49 1.43 -42.57
42. BRAZIL 14.54 1.00
43. MALDIVES 76.90 14.42 -81.24 5.63 1.21 -78.58
44. MOZAMBIQUE 11.43 12.87 12.57 1.72 1.62 -5.54
45. SEYCHELLES 0.13 11.86 8,914.82 0.07 1.00 1,415.15
46. PERU 19.98 11.29 -43.51 0.20 0.09 -57.29
47. U ARAB EMTS 10.87 0.60
48. DOMINIC REP 42.39 9.32 -78.02 1.10 0.20 -81.82
49. PARAGUAY 8.35 0.68
50. BHUTAN 7.07 1.00
51. MALAWI 6.87 6.50 -5.42 0.97 1.41 45.21
52. JORDAN 6.01 1.13
53. COTE D' IVOIRE 4.49 1.00
54. UGANDA 8.51 4.32 -49.16 0.34 0.83 143.70
55. BOTSWANA 3.92 4.28 9.18 0.36 0.47 31.28
56. CAMBODIA 6.39 3.35 -47.51 1.37 0.80 -41.43
57. TOGO 1.42 3.14 120.70 0.29 0.27 -8.22
58. LIBERIA 7.82 3.03 -61.27 0.37 0.25 -32.25
59. RWANDA 1.78 2.27 27.92 0.23 0.17 -23.25
60. FIJI IS 0.69 2.19 218.91 0.01 0.14 938.46
61. MONGOLIA 1.91 0.08
62. CONGO D. REP. 35.30 1.85 -94.75 7.14 0.20 -97.20
63. GAMBIA 1.79 0.17
64. TRINIDAD 2.89 1.61 -44.37 0.67 0.05 -92.49
65. GUATEMALA 1.59 0.03
66. TURKEY 0.18 1.35 636.72 0.01 0.04 300.00
67. BANGLADESH PR 131.30 0.95 -99.27 0.10 0.01 -84.69
68. GUINEA 0.82 0.03
69. COLOMBIA 3.94 0.81 -79.45 0.05 0.03 -50.91
70. BOLIVIA 0.03 0.32 956.39 0.00 0.01 233.33
71. U S A 5.93 0.12 -97.99 0.95 0.01 -98.95
72. GERMANY 0.11 0.01
73. NIGER 34.38 0.03 -99.90 0.51 0.00 -99.22
74. KAZAKHSTAN 0.03 0.00
75. BELARUS 0.03 0.00
76. PANAMA REPUBLIC 0.02 0.01
77. QATAR 0.18 0.02
78. ROMANIA 0.14 0.00
80. SAUDI ARAB 1.80 0.05
81. LITHUANIA 0.32 0.02
82. MALI 2.29 0.10
83. CHAD 9.01 0.24
84. CHILE 0.21 0.00
85. BURUNDI 1.46 0.02
86. BAHARAIN IS 13.92 0.71
87. ERITREA 2.40 1.00
88. CROATIA 2.74 0.03
89. GUYANA 3.77 0.17
90. HAITI 6.22 0.33
91. IRAN 182.30 8.84
92. GREECE 1.09 0.03
93. ISRAEL 0.07 0.00
94. TURKMENISTAN 1.80 0.06
95. TUNISIA 0.67 0.01
96. THAILAND 1.71 0.01
97. UKRAINE 199.30 0.23
Total 7,718.46 5,786.29 -25.03
Commodity: 30045010 HEAMATINICS AND ERYTHROPOIETIN Unit: KGS

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. BRAZIL 6.38 0.00
2. CHINA P RP 101.23 0.03
3. IRELAND 1,027.96 0.43
4. KOREA RP 714.23 706.79 -1.04 0.17 0.28 64.88
5. USA 6.85 0.00
Total 1,843.42 720.02 -60.94

Countries: Nigeria, Algeria, Sri Lanka, Kenya, Lebanon, Benin, Myanmar, Nepal,
Vietnam, Yemen, Suriname, Tanzania, Uruguay, Latvia, Australia
Region: Africa, Middle East Asia, Neighboring countries, Far East Asia, CIS, Australia
6. ISOPREG SR Tab:
Contents: ISOXSUPRINE 40 MG SR TAB
Indications: Smooth Muscles Relaxant, Especially in pregnancy
Specialty: Gynecology
Basic Information: Isoxsuprine it is used in humans for treatment of premature labor,

i.e. a tocolytic, and as a vasodilator for the treatment of cerebral vascular
insufficiency, Raynaud's phenomenon, and other conditions.
Isoxsuprine may increase the heart rate, cause changes in blood pressure, and irritate the
GI tract. It should therefore be used with caution if combined with other drugs that affect
blood pressure, such as sedatives and anesthetic drugs.
HS Code: 30049099

300490  Other
3004099  Other

Duty Drawback: -
Commodity: 30049099 OTHER MEDCNE PUT UP FOR RETAIL SALE N.E.S Unit: KGS

2012- 2013-
2012-2013 2013-2014 %Growth %Growth
2013 2014
1. USA 692,553.76 828,084.65 19.57 16,310.52 19,455.86 19.28
2. SOUTH AFRICA 107,628.55 198,417.36 84.35 2,633.03 4,843.38 83.95
3. RUSSIA 80,764.08 80,041.31 -0.89 3,280.55 2,361.99 -28.00
4. KENYA 70,077.96 76,782.37 9.57 2,768.15 2,407.90 -13.01
5. UK 55,884.64 62,434.13 11.72 3,558.03 5,489.30 54.28
6. NIGERIA 52,472.96 56,984.23 8.60 4,042.26 4,795.31 18.63
7. ZAMBIA 19,701.08 55,560.87 182.02 794.29 2,089.91 163.12
8. TANZANIA REP 38,027.79 50,004.74 31.50 1,284.99 2,744.00 113.54
9. UGANDA 30,262.34 47,987.67 58.57 1,190.51 1,751.19 47.10
10. GHANA 56,141.32 46,168.09 -17.76 3,094.27 3,171.20 2.49
11. CANADA 31,881.57 41,182.96 29.17 815.53 1,077.41 32.11
12. SRI LANKA DSR 30,895.57 37,907.46 22.70 2,186.07 2,524.10 15.46
13. GERMANY 46,706.23 36,989.36 -20.80 1,927.99 1,271.13 -34.07
14. ETHIOPIA 15,020.06 36,568.94 143.47 853.71 1,313.47 53.85
15. VIETNAM SOC REP 27,327.31 36,263.41 32.70 1,202.69 1,404.40 16.77
16. BRAZIL 33,577.30 33,090.45 -1.45 803.64 1,049.39 30.58
17. MYANMAR 22,465.71 32,790.88 45.96 1,660.65 1,870.17 12.62
18. UNSPECIFIED 6,138.44 29,545.73 381.32 94.57 491.57 419.81
19. PHILIPPINES 19,145.90 28,673.70 49.76 998.81 1,590.13 59.20
20. MALAWI 25,234.16 28,303.11 12.16 532.34 625.89 17.57
21. JAPAN 23,909.62 24,776.30 3.62 160.99 253.59 57.52
22. AUSTRALIA 23,028.79 24,576.59 6.72 1,190.70 1,148.50 -3.54
23. NETHERLAND 19,180.21 22,501.54 17.32 1,144.77 1,224.94 7.00
24. VENEZUELA 16,563.35 21,942.59 32.48 340.02 287.80 -15.36
25. FRANCE 18,707.79 21,177.94 13.20 1,087.64 1,204.06 10.70
26. ZIMBABWE 29,898.61 20,515.59 -31.38 991.70 551.07 -44.43
27. IRAN 14,891.06 19,839.02 33.23 531.42 461.85 -13.09
28. SLOVENIA 20,339.89 17,508.55 -13.92 180.81 170.34 -5.79
29. ANGOLA 8,500.99 17,469.38 105.50 1,933.87 1,971.35 1.94
30. BOTSWANA 13,954.67 17,043.56 22.14 407.31 408.35 0.25
31. MOZAMBIQUE 7,947.14 15,172.17 90.91 732.37 692.88 -5.39
32. THAILAND 14,726.30 14,322.03 -2.75 1,672.08 1,005.01 -39.89
33. BELGIUM 13,027.95 14,025.69 7.66 665.20 550.16 -17.29
34. UKRAINE 19,432.23 12,398.75 -36.19 1,318.39 649.37 -50.75
35. CAMEROON 6,333.50 12,136.34 91.62 561.95 515.07 -8.34
36. IRAQ 12,173.59 11,765.81 -3.35 964.35 3,642.48 277.71
37. BENIN 11,953.74 11,722.43 -1.94 1,788.94 1,343.02 -24.93
38. HUNGARY 9,147.12 11,487.78 25.59 303.45 175.60 -42.13
39. CONGO D. REP. 6,115.45 10,252.13 67.64 502.51 1,229.01 144.57
40. YEMEN REPUBLC 6,878.69 10,140.96 47.43 1,010.14 1,772.73 75.49
41. MALAYSIA 7,093.54 9,305.41 31.18 402.45 426.86 6.07
42. CHILE 9,364.61 9,287.44 -0.82 745.97 639.37 -14.29
43. CAMBODIA 4,940.22 9,075.52 83.71 1,637.75 1,112.61 -32.06
44. RWANDA 5,274.90 8,958.96 69.84 181.94 187.81 3.23
45. COLOMBIA 10,634.06 8,891.37 -16.39 290.98 537.15 84.60
46. SUDAN 5,955.72 8,848.51 48.57 317.13 561.60 77.09
47. KAZAKHSTAN 8,566.42 8,788.84 2.60 483.63 191.86 -60.33
48. MAURITIUS 6,362.29 8,718.65 37.04 338.15 381.41 12.79
49. ALGERIA 6,990.44 8,475.57 21.25 246.52 142.05 -42.38
50. BURKINA FASO 6,602.24 8,286.73 25.51 234.85 436.23 85.75
51. SINGAPORE 8,193.92 8,065.20 -1.57 475.96 239.43 -49.69
52. GUINEA 4,682.58 8,041.54 71.73 622.25 903.08 45.13
53. NIGER 4,657.54 7,906.28 69.75 609.26 1,039.53 70.62
54. U ARAB EMTS 4,518.91 7,257.22 60.60 321.82 485.60 50.89
55. DOMINIC REP 5,787.79 7,138.46 23.34 225.63 414.31 83.63
56. NEPAL 6,565.37 7,017.53 6.89 897.20 814.67 -9.20
57. LESOTHO 5,479.46 6,818.41 24.44 134.62 145.61 8.17
58. FINLAND 4,357.09 6,712.84 54.07 134.57 190.79 41.77
59. NAMIBIA 7,858.40 6,678.66 -15.01 170.48 305.54 79.23
60. NEW ZEALAND 4,387.30 6,029.27 37.43 271.56 334.58 23.20
61. ROMANIA 6,464.86 5,849.62 -9.52 153.07 131.42 -14.14
62. PERU 3,785.22 5,669.78 49.79 180.02 211.58 17.53
63. UZBEKISTAN 4,289.60 5,527.91 28.87 361.67 475.50 31.47
64. SPAIN 5,563.67 5,422.09 -2.54 373.76 217.96 -41.69
65. IRELAND 6,503.02 5,391.93 -17.09 289.74 429.08 48.09
66. JAMAICA 3,224.90 5,373.65 66.63 141.54 160.43 13.35
67. TURKMENISTAN 2,554.22 5,132.02 100.92 296.40 896.12 202.34
68. CONGO P REP 4,795.18 4,859.18 1.33 378.55 569.36 50.41
69. AFGHANISTAN TIS 3,590.56 4,802.71 33.76 1,235.67 716.39 -42.02
70. MALTA 4,624.39 4,739.99 2.50 240.15 214.20 -10.81
71. PORTUGAL 3,470.45 4,396.44 26.68 217.10 391.65 80.40
72. TAJIKISTAN 1,261.74 4,376.60 246.87 217.67 1,003.39 360.98
73. TOGO 3,393.99 4,324.64 27.42 417.86 311.77 -25.39
74. POLAND 5,883.06 4,301.39 -26.89 56.92 67.09 17.88
75. MOROCCO 2,848.00 4,220.51 48.19 71.84 65.72 -8.52
76. INDONESIA 1,878.31 4,098.59 118.21 343.50 516.88 50.47
77. SWAZILAND 6,849.66 4,056.04 -40.78 97.21 123.00 26.53
78. MEXICO 4,289.44 3,990.79 -6.96 150.44 135.18 -10.14
79. DENMARK 3,831.75 3,951.15 3.12 331.70 316.31 -4.64
80. HONG KONG 2,911.00 3,798.20 30.48 58.64 96.98 65.40
81. SWITZERLAND 3,019.41 3,752.81 24.29 168.06 75.26 -55.22
82. JORDAN 2,768.18 3,280.50 18.51 283.69 414.99 46.28
83. LEBANON 1,207.23 3,275.83 171.35 22.55 112.69 399.79
84. CHAD 2,265.74 3,254.05 43.62 153.97 180.82 17.44
85. BURUNDI 2,489.06 3,137.37 26.05 131.76 207.67 57.62
86. ITALY 3,861.46 3,080.80 -20.22 156.97 153.54 -2.19
87. SYRIA 1,989.47 2,985.12 50.05 56.29 1,311.66 2,230.15
88. CUBA 1,421.71 2,971.76 109.03 70.01 88.01 25.72
89. TURKEY 2,353.69 2,951.16 25.38 118.07 93.07 -21.17
90. KOREA RP 1,685.57 2,879.49 70.83 86.07 37.00 -57.01
91. CROATIA 2,926.87 2,866.50 -2.06 36.35 56.72 56.00
92. LIBYA 3,210.74 2,838.07 -11.61 293.09 241.72 -17.53
93. PAKISTAN IR 1,364.86 2,736.90 100.53 100.56 259.15 157.72
94. HAITI 3,327.33 2,729.73 -17.96 264.45 203.85 -22.92
95. MALDIVES 2,272.90 2,676.02 17.74 229.27 142.29 -37.94
96. PAPUA N GNA 1,699.71 2,655.24 56.22 507.83 271.15 -46.60
97. SWEDEN 1,909.81 2,643.73 38.43 84.61 162.15 91.66
98. TRINIDAD 2,049.75 2,581.34 25.93 133.08 107.03 -19.58
99. COSTA RICA 2,282.97 2,532.01 10.91 101.12 114.65 13.39
100. CZECH REPUBLIC 3,572.13 2,511.72 -29.69 69.92 102.86 47.12
101. MALI 2,823.88 2,481.35 -12.13 274.63 245.32 -10.67
102. SENEGAL 1,278.75 2,443.26 91.07 109.32 164.20 50.20
103. SOMALIA 1,219.63 2,442.00 100.23 412.96 424.46 2.79
104. LITHUANIA 1,332.39 2,418.36 81.50 49.66 76.08 53.18
105. ECUADOR 2,389.88 2,414.93 1.05 31.49 53.76 70.75
106. GUATEMALA 2,045.46 2,400.80 17.37 120.07 197.60 64.58
107. BELARUS 1,800.56 2,375.29 31.92 51.42 69.21 34.62
108. COTE D' IVOIRE 1,950.37 2,219.84 13.82 176.80 104.33 -40.99
109. PANAMA REPUBLIC 2,338.05 2,122.79 -9.21 71.16 77.59 9.04
110. BULGARIA 1,573.47 2,066.15 31.31 50.13 75.87 51.34
111. SIERRA LEONE 1,671.71 1,898.23 13.55 635.47 251.41 -60.44
112. MADAGASCAR 2,091.06 1,890.17 -9.61 296.13 186.50 -37.02
113. LATVIA 986.52 1,874.87 90.05 123.82 147.18 18.87
114. GUYANA 1,514.10 1,855.33 22.54 110.13 161.21 46.39
115. EL SALVADOR 1,734.62 1,836.62 5.88 115.64 152.59 31.96
116. ERITREA 996.78 1,813.21 81.91 78.97 94.44 19.59
117. GEORGIA 1,602.58 1,798.71 12.24 165.77 121.86 -26.49
118. AUSTRIA 2,747.78 1,771.75 -35.52 38.53 42.64 10.67
119. BOLIVIA 2,141.28 1,738.85 -18.79 243.16 98.77 -59.38
120. LIBERIA 1,622.98 1,606.53 -1.01 431.41 152.57 -64.63
121. GABON 1,308.66 1,569.82 19.96 46.05 32.20 -30.08
122. KYRGHYZSTAN 914.45 1,453.84 58.99 157.90 117.46 -25.61
123. OMAN 1,050.40 1,391.37 32.46 35.84 47.68 33.02
124. TAIWAN 758.20 1,250.84 64.98 13.65 19.49 42.73
125. NICARAGUA 1,540.09 1,205.88 -21.70 208.28 155.84 -25.18
126. C AFRI REP 1,419.97 1,146.73 -19.24 29.29 74.92 155.75
127. EGYPT A RP 1,173.87 1,127.16 -3.98 66.10 45.65 -30.93
128. CHINA P RP 747.07 1,126.88 50.84 18.09 51.68 185.69
129. SERBIA 1,124.10 8.47
130. MAURITANIA 419.18 1,027.62 145.15 58.64 131.51 124.27
131. UNION OF SERBIA & 1,483.07 1,026.94 -30.76 45.60 58.18 27.58
MONTENEGRO
132. MOLDOVA 967.09 956.49 -1.10 45.38 46.49 2.44
133. GAMBIA 554.55 953.30 71.91 81.77 74.10 -9.38
134. URUGUAY 1,361.38 952.69 -30.02 14.94 12.26 -17.96
135. VANUATU REP 1,062.00 952.37 -10.32 9.64 11.16 15.83
136. HONDURAS 2,773.69 827.07 -70.18 107.77 87.31 -18.99
137. ARGENTINA 651.59 820.23 25.88 5.60 11.44 104.16
138. AZERBAIJAN 1,451.50 791.54 -45.47 101.40 69.30 -31.66
139. SEYCHELLES 549.40 790.03 43.80 19.28 41.03 112.84
140. SAUDI ARAB 549.71 730.05 32.81 41.23 74.25 80.09
141. FIJI IS 702.67 633.50 -9.84 108.39 38.99 -64.03
142. CYPRUS 683.98 613.09 -10.36 12.05 17.41 44.44
143. BANGLADESH PR 804.09 592.66 -26.30 21.23 21.40 0.80
144. PARAGUAY 729.76 584.87 -19.85 20.48 10.71 -47.69
145. KOREA DP RP 521.52 478.88 -8.18 36.74 35.85 -2.41
146. SLOVAK REP 1,753.16 471.52 -73.10 24.36 9.35 -61.62
147. GUINEA BISSAU 263.05 441.41 67.80 19.11 36.00 88.35
148. BAHAMAS 466.69 412.48 -11.62 14.67 10.15 -30.80
149. BHUTAN 397.77 384.62 -3.31 35.51 108.86 206.54
151. MONGOLIA 223.26 351.14 57.28 16.39 29.20 78.22
152. BAHARAIN IS 427.79 347.19 -18.84 8.98 5.73 -36.21
153. SURINAME 155.89 344.39 120.92 8.37 7.94 -5.15
154. LAO PD RP 160.52 314.96 96.21 9.63 10.87 12.89
155. BOSNIA-HRZGOVIN 256.97 302.82 17.84 9.72 12.46 28.16
156. MACEDONIA 288.32 302.51 4.92 4.23 4.11 -2.77
157. EQUTL GUINEA 441.60 295.74 -33.03 57.52 31.80 -44.73
158. KUWAIT 122.60 287.74 134.69 9.81 19.78 101.72
159. ISRAEL 208.76 279.19 33.74 7.45 21.08 182.81
160. DJIBOUTI 192.69 271.73 41.02 39.83 8.04 -79.81
161. ARMENIA 123.86 234.24 89.11 11.06 12.82 15.99
162. GREECE 822.45 216.21 -73.71 39.71 6.05 -84.76
163. ST LUCIA 97.19 188.31 93.75 5.26 11.35 115.78
164. BARBADOS 616.58 131.34 -78.70 20.61 5.82 -71.75
165. MICRONESIA 90.81 101.34 11.60 1.88 3.67 95.37
166. BELIZE 141.73 97.32 -31.34 7.51 2.83 -62.26
167. FR GUIANA 85.08 1.30
168. QATAR 164.49 85.06 -48.29 14.84 8.58 -42.23
169. TONGA 19.55 80.00 309.30 0.19 12.42 6,576.34
170. SOLOMON IS 53.16 71.91 35.29 7.39 2.09 -71.66
171. COMOROS 13.72 70.17 411.31 1.30 36.06 2,682.41
172. ANTIGUA 52.77 65.67 24.45 1.30 1.34 2.85
173. CAYMAN IS 19.26 63.95 232.07 0.37 2.28 521.58
174. SAMOA 39.63 57.12 44.15 0.99 10.35 943.85
175. ESTONIA 184.33 51.87 -71.86 5.84 5.30 -9.20
176. MACAO 73.51 51.76 -29.59 3.22 1.25 -61.20
177. CAPE VERDE IS 29.07 48.20 65.83 0.39 1.13 190.75
178. ST KITT N A 38.86 43.06 10.80 0.95 2.03 114.24
179. TUNISIA 204.06 34.09 -83.29 1.89 0.79 -58.28
180. ST VINCENT 39.96 33.06 -17.28 0.83 0.78 -6.83
181. NORWAY 67.76 31.29 -53.82 10.77 1.05 -90.22
182. GRENADA 22.56 26.43 17.16 0.88 0.99 12.12
183. SAO TOME 14.62 26.07 78.27 0.23 0.76 234.21
184. MONTENEGRO 25.56 0.33
185. DOMINICA 326.29 23.11 -92.92 10.05 1.06 -89.45
186. ALBANIA 57.26 18.76 -67.23 1.77 0.48 -72.82
187. LUXEMBOURG 16.91 18.51 9.50 0.09 0.16 75.56
188. TIMOR LESTE 311.06 17.46 -94.39 14.21 2.18 -84.65
189. BR VIRGN IS 0.08 13.66 17,168.14 0.02 0.16 695.00
190. PALAU 16.00 12.14 -24.09 0.14 0.11 -18.84
191. KIRIBATI REP 3.50 11.70 234.44 0.90 0.68 -25.00
192. MARSHALL ISLAND 12.87 7.93 -38.35 0.33 0.25 -23.31
193. ICELAND 35.73 4.61 -87.09 0.55 0.32 -42.55
194. PUERTO RICO 0.42 4.38 954.08 0.02 0.25 1,150.00
195. BRUNEI 2.30 0.06
196. GUAM 103.37 2.02 -98.05 3.32 0.38 -88.57
197. MONTSERRAT 0.64 1.84 188.79 0.00 0.05 1,700.00
198. NAURU RP 1.76 0.03
199. ANGUILLA 1.03 1.70 64.98 0.03 0.03 -12.12
200. GIBRALTAR 1.67 0.04
201. TUVALU 0.44 0.03
202. REUNION 0.09 0.02
203. PANAMA C Z 0.02 0.00
Total 2,086,427.98 2,560,318.81 22.71
Approximate amount of Import Country wise from India:

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. SWITZERLAND 42,316.70 43,137.38 1.94 43.75 57.57 31.61
2. GERMANY 26,205.81 35,640.97 36.00 21.43 97.39 354.53
3. USA 29,105.65 32,629.05 12.11 27.80 45.67 64.27
4. ITALY 25,638.39 23,354.98 -8.91 18.00 38.91 116.19
5. UK 18,735.12 21,618.33 15.39 16.37 39.12 139.00
6. FRANCE 18,984.63 15,853.37 -16.49 18.72 24.01 28.28
7. NETHERLAND 8,196.64 10,341.38 26.17 6.83 13.94 104.07
8. BELGIUM 5,680.04 6,602.63 16.24 9.81 8.71 -11.16
9. IRELAND 8,403.77 5,705.67 -32.11 5.06 7.09 39.93
10. CANADA 2,243.56 5,163.37 130.14 2.94 12.28 317.87
11. FINLAND 2,101.45 5,086.05 142.03 1.95 20.69 963.80
12. CHINA P RP 3,585.55 4,574.38 27.58 6.53 25.94 297.15
13. SWEDEN 3,824.99 4,515.30 18.05 5.26 21.88 315.74
14. DENMARK 4,560.32 4,265.60 -6.46 4.06 4.14 1.87
15. PUERTO RICO 2,065.22 3,915.67 89.60 1.33 7.16 439.59
16. MEXICO 2,126.68 2,740.39 28.86 2.58 2.90 12.57
17. JAPAN 5,269.03 2,334.33 -55.70 5.24 2.68 -48.92
18. SPAIN 1,775.61 1,589.65 -10.47 2.91 2.99 2.92
19. AUSTRALIA 888.58 1,549.93 74.43 1.64 2.13 30.24
20. AUSTRIA 2,214.01 1,486.62 -32.85 2.61 1.65 -36.75
21. SINGAPORE 1,025.68 1,312.70 27.98 1.16 2.64 126.44
22. SOUTH AFRICA 791.27 947.76 19.78 4.91 0.80 -83.75
23. KOREA RP 989.10 785.44 -20.59 0.91 0.88 -3.07
24. MALAYSIA 2,076.59 720.81 -65.29 2.13 18.88 785.19
25. HUNGARY 126.44 634.29 401.63 0.61 0.84 39.50
26. TAIWAN 75.77 521.65 588.45 0.07 0.74 909.59
27. BRAZIL 454.66 457.00 0.52 0.49 0.36 -26.83
28. MALTA 319.27 432.33 35.41 0.58 0.32 -45.42
29. UNSPECIFIED 96.37 270.73 180.91 0.40 0.20 -49.88
30. CZECH REPUBLIC 129.80 194.77 50.05 1.22 11.37 833.58
31. ISRAEL 405.25 188.96 -53.37 0.87 1.07 22.08
32. URUGUAY 114.54 0.11
33. TURKEY 192.09 108.00 -43.78 0.08 0.32 289.02
34. RUSSIA 3.86 95.18 2,363.20 0.00 0.08 1,400.00
35. POLAND 176.58 39.89 -77.41 0.16 0.08 -47.77
36. ARGENTINA 30.30 36.34 19.91 0.03 0.01 -75.86
37. SLOVAK REP 26.31 0.03
38. PHILIPPINES 39.95 21.95 -45.07 0.07 0.02 -72.60
39. BULGARIA 4.33 21.93 406.41 0.00 0.02 375.00
40. PORTUGAL 29.63 20.98 -29.18 0.04 0.02 -46.34
41. HONG KONG 114.69 18.48 -83.89 0.11 0.01 -90.83
42. THAILAND 6.72 14.58 116.99 0.01 0.01 0.00
43. CYPRUS 3.83 12.47 225.47 0.00 0.02 325.00
44. LITHUANIA 11.05 0.01
45. U ARAB EMTS 10.46 10.21 -2.40 0.00 0.01 20.00
46. NEW ZEALAND 7.69 6.60 -14.24 0.01 0.01 100.00
47. MALDIVES 6.03 0.01
48. CHILE 63.37 5.01 -92.09 1.04 0.00 -99.52
49. LIBERIA 4.84 0.00
50. GREECE 7.85 2.38 -69.73 0.01 0.01 -46.15
52. ICELAND 15.80 1.84 -88.37 0.01 0.00 -70.00
53. SLOVENIA 21.89 1.82 -91.70 0.09 0.00 -97.73
54. AFGHANISTAN TIS 1.37 0.01
55. INDONESIA 0.99 1.00 1.22 0.00 0.00 0.00
56. LATVIA 6.21 0.97 -84.42 0.01 0.00 -87.50
57. ROMANIA 11.08 0.79 -92.84 0.01 0.01 -53.85
58. MOROCCO 0.10 0.62 546.69 0.00 0.01 175.00
59. GEORGIA 0.42 0.00
60. KENYA 0.38 0.14 -62.49 0.00
61. CROATIA 0.05 0.02 -58.08
62. COSTA RICA 0.02
63. ALGERIA 0.54 0.00
64. BANGLADESH PR 0.04
65. GABON 0.30
66. JORDAN 0.09
67. JAMAICA 0.69
68. KOREA DP RP 6.35 0.00
69. NAMIBIA 0.51
71. PERU 42.03 0.04
72. SAUDI ARAB 1.18 0.01
74. SWAZILAND 57.13 0.04
75. VENEZUELA 3.37
76. ZAMBIA 1.61 0.00
77. UKRAINE 0.16
Total 221,274.41 239,159.18 8.08
Major Export Markets
Countries: USA, South Africa, Kenya, UK, Nigeria, Zambia, Tanzania, Uganda, Ghana,
Canada, Sri Lanka, Germany, Ethiopia, Vietnam
Region: North America, Africa, Far East Asia, West Europe
7. LARG 9 SACHET
Contents: L-Arginine 3gm sachet
Basic Information: Eggs, meats, milk, soy proteins, peanuts, and walnuts are all sources
of arginine. The physiologically active form, L-arginine, is obtained by breaking down
proteins. Arginine also may be synthesized in the laboratory. Because L-arginine may be
synthesized in the body, it is classified as a nonessential amino acid in adults. However,
in children and in people with certain conditions (eg, infection, trauma), L-arginine
synthesis may become compromised and then may be considered semi-essential.
L-arginine is a nonessential amino acid that may play an important role in the treatment
of heart disease due to its block arterial plaque buildup, blood clots, platelet clumping,
and to increase blood flow through the coronary artery. L-arginine is commonly sold as a
health supplement claiming to improve vascular health and treat erectile dysfunction in
men. L-arginine, which is promoted as a human growth stimulant, has also been used in
bodybuilding. In the 1800s, it was first isolated from animal horn.
Indications: Vaso Dilator, Mainly used in erectile dysfunction, vascular health, for bette
blood circulation.
Branches: Gynecology, Neurology, GP
HS Code: 29224990
29  Organic Chemicals
2922  Harmonized Codes of Oxygen-function amino-compounds
292249  Other
29224990  Other

Duty Drawback: -
Commodity: 29224990 OTHER AMINO ACIDS AND THR ESTERS CNTNG NOT MORE THAN
ONE KIND OXGN FN. Unit: KGS
2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. USA 15,831.14 19,829.88 25.26 794.93 954.82 20.11
2. GERMANY 1,252.50 1,524.12 21.69 275.01 262.93 -4.39
3. NETHERLAND 372.00 956.63 157.16 101.61 205.10 101.85
4. ITALY 362.98 621.76 71.29 13.44 22.72 68.98
5. FRANCE 134.82 566.39 320.09 18.58 54.36 192.56
6. RUSSIA 7.54 559.20 7,317.66 0.01 0.51 4,509.09
7. JAPAN 793.97 518.53 -34.69 261.85 155.02 -40.80
8. BANGLADESH PR 304.38 502.84 65.20 37.92 55.09 45.30
9. CHINA P RP 57.31 500.73 773.74 1.47 167.52 11,264.93
10. MEXICO 677.34 343.91 -49.23 26.11 8.02 -69.30
11. U K 375.98 327.69 -12.84 122.61 108.65 -11.39
12. IRAN 126.78 324.13 155.67 47.39 104.00 119.45
13. PAKISTAN IR 105.65 272.24 157.68 19.33 25.81 33.48
14. EGYPT A RP 100.42 217.42 116.50 1.47 2.19 49.18
15. SPAIN 46.67 201.36 331.43 2.52 16.76 565.42
16. KOREA RP 457.31 196.77 -56.97 8.21 21.61 163.18
17. THAILAND 60.06 186.78 211.01 31.83 35.19 10.54
18. TAIWAN 100.46 157.81 57.09 21.19 77.02 263.38
19. SAUDI ARAB 1.33 134.40 9,985.24 2.94 12.96 340.33
20. VIETNAM SOC REP 63.65 117.68 84.90 26.47 50.48 90.72
21. BRAZIL 164.30 112.72 -31.40 10.16 15.98 57.22
22. INDONESIA 65.87 111.05 68.59 4.86 12.03 147.29
23. U ARAB EMTS 51.51 103.08 100.13 16.96 10.79 -36.36
24. AUSTRALIA 153.81 91.83 -40.30 46.65 29.78 -36.16
25. ARGENTINA 35.89 91.43 154.76 3.75 2.95 -21.23
26. SERBIA 87.74 3.00
27. ALGERIA 0.11 87.72 80,601.47 0.00 0.41 13,400.00
28. SLOVENIA 72.69 3.05
29. SOUTH AFRICA 2.29 71.70 3,037.16 0.03 26.20 87,233.34
30. TURKEY 15.94 66.31 316.05 0.71 2.80 293.68
31. SYRIA 32.66 65.34 100.08 2.90 1.00 -65.52
32. SWEDEN 47.38 34.00
33. GUATEMALA 43.00 0.86
34. CANADA 63.11 38.28 -39.34 19.30 20.02 3.77
35. HONG KONG 23.98 37.45 56.19 2.34 2.37 1.46
36. CUBA 35.09 18.90
37. ECUADOR 33.51 13.00
38. SINGAPORE 0.66 32.50 4,816.02 0.20 1.66 707.80
39. LEBANON 30.52 0.26
40. NEW ZEALAND 19.69 28.10 42.69 5.38 6.70 24.58
41. ISRAEL 1.53 24.43 1,491.82 0.42 0.12 -72.55
42. KENYA 4.29 22.19 417.16 0.32 10.71 3,225.16
43. NEPAL 6.13 20.95 241.54 0.10 2.35 2,160.58
44. AUSTRIA 20.04 19.73 -1.54 0.06 0.02 -69.23
45. HUNGARY 16.99 0.04
46. URUGUAY 16.47 0.07
47. FINLAND 26.47 16.41 -38.00 6.04 3.40 -43.68
48. PORTUGAL 0.91 15.23 1,567.35 0.10 0.12 20.00
49. COLOMBIA 14.12 15.11 6.97 0.34 0.24 -29.33
50. SWITZERLAND 49.48 14.96 -69.76 7.12 0.03 -99.59
51. MOROCCO 2.97 11.20 277.13 0.02 12.01 59,960.00
52. DENMARK 9.66 0.20
53. PERU 0.32 9.45 2,810.34 0.09 2.25 2,404.44
54. LATVIA 8.99 0.04
55. EL SALVADOR 3.15 8.96 184.42 0.03 0.08 141.94
56. NIGERIA 1.82 8.45 364.39 12.71 0.09 -99.25
57. YEMEN REPUBLC 4.46 5.78 29.65 10.60 0.30 -97.17
58. MALAYSIA 16.51 5.21 -68.43 1.69 6.00 255.06
59. GHANA 4.59 4.22 -8.05 5.70 0.53 -90.77
60. SRI LANKA DSR 3.57 4.06 13.61 1.55 1.74 12.55
61. JORDAN 2.67 2.30 -14.02 0.20 0.20 -0.99
62. PARAGUAY 2.02 1.00
63. TUNISIA 1.29 0.01
64. CYPRUS 1.24 0.01
65. CONGO D. REP. 1.04 0.10
66. CONGO P REP 0.52 0.05
67. IRAQ 0.45 0.12
68. ETHIOPIA 0.51 0.35 -32.34 0.16 0.06 -58.71
69. RWANDA 0.32 0.10
70. MALAWI 0.15 0.04
71. ZAMBIA 1.72 0.15 -91.13 3.62 0.01 -99.72
72. PHILIPPINES 2.70 0.13 -95.26 0.98 0.03 -97.34
73. OMAN 0.11 0.00
74. KUWAIT 0.03 0.10 301.17 0.01 0.02 140.00
75. GUYANA 0.07 0.02
76. CHILE 0.07 0.00
77. BAHARAIN IS 0.04 0.00
78. BURUNDI 1.09 1.50
79. BELGIUM 1.27 0.26
80. COSTA RICA 2.75 13.00
82. JAMAICA 1.37 1.08
83. POLAND 14.74 0.04
84. ROMANIA 1.20 0.50
85. UZBEKISTAN 0.69 0.10
86. TANZANIA REP 0.04 0.03
87. SUDAN 0.20 0.84
Total 22,055.86 29,616.51 34.28
Approximate amount of Import Countrywise to India
Commodity: 29224990 OTHER AMINO ACIDS AND THR ESTERS CNTNG NOT MORE THAN
ONE KIND OXGN FN. Unit: KGS
2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. ARGENTINA 2.22 0.30
2. AUSTRIA 149.31 2.70
3. BELGIUM 253.74 62.38 -75.41 27.28 0.22 -99.20
4. BRAZIL 1,283.51 1,029.84 -19.76 185.05 109.04 -41.08
5. CANADA 106.91 260.55
6. TAIWAN 40.79 86.02 110.92 1.29 0.51 -60.87
7. CHINA P RP 16,273.13 25,319.92 55.59 3,702.41 5,483.60 48.11
8. ESTONIA 0.41 0.01
9. FRANCE 638.49 61.21 -90.41 87.96 1.74 -98.03
10. GERMANY 11,054.09 9,790.91 -11.43 612.51 1,067.13 74.22
11. HONG KONG 642.53 224.41 -65.07 15.35 7.40 -51.82
12. ICELAND 112.46 3.00
13. INDONESIA 38.30 234.27 511.60 20.13 58.04 188.40
14. IRAN 0.01 0.00
15. IRELAND 0.33 0.01 -96.86 0.03 0.00 -92.86
16. ISRAEL 1,629.39 1,538.13 -5.60 44.43 41.94 -5.60
17. ITALY 3,618.04 1,187.07 -67.19 103.16 34.66 -66.40
18. JAPAN 2,414.08 1,648.30 -31.72 121.15 72.82 -39.89
19. JORDAN 0.11 0.00
20. KOREA RP 33.57 707.01 2,006.13 4.30 22.50 422.67
21. MALAYSIA 0.04 0.08 108.00 0.00 0.00 200.00
22. MEXICO 0.66 0.67 2.05 0.02 0.05 131.82
23. NEPAL 0.03 0.00
24. NETHERLAND 212.59 505.13 137.61 59.76 143.98 140.96
26. POLAND 120.10 270.07 124.86 3.43 0.09 -97.23
27. SINGAPORE 49.75 222.86 347.94 3.30 11.37 244.98
28. SLOVENIA 0.01 0.00
29. SPAIN 119.61 39.91 -66.63 4.36 7.52 72.45
30. SWEDEN 0.12 0.00
31. SWITZERLAND 355.45 177.30 -50.12 7.95 1.60 -79.92
32. THAILAND 6.76 5.00
33. U K 46.06 784.03 1,602.15 10.39 224.52 2,060.54
34. U S A 2,840.69 3,608.91 27.04 597.95 737.99 23.42
Total 41,935.54 47,672.60 13.68
Countries: USA, Germany, Netherlands, Italy, France, Russia, Japan, Bangladesh,

China, Mexico, UK, Iran, Pakistan, Egypt, Spain
Region: N. America, Europe, Russia, Far East Asia, Neighboring countries (Including
China), Egypt
8. REDCOR XT TAB, REDCOR XT SYP
Contents: REDCOR XT TAB: Ferrous ascorbate 100 mg, Folic acide 5 mg

REDCOR XT SYP: Ferrous ascorbate 100 mg, Folic acid 5 mg, zinc sulphate
Basic Information: Ferrous Ascorbate & Folic Acid, a synthetic form of iron and
vitamin C is prescribed for pregnant women to prevent spina bifida in an unborn fetus, to
improve iron utilization and to prevent folate or iron deficiency anemia.
Indications: Iron supplement, iron deficiency, anemia

HS Code: 30045090

packing for retail sale
30045090  Preparations of vitamins: Other

Duty Drawback: -
Commodity: 30045090 OTHERS PUT UP FOR RETAIL SALE Unit: KGS

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. NIGERIA 9,604.98 12,528.86 30.44 2,186.44 2,292.90 4.87
2. CONGO P REP 5,621.85 10,187.50 81.21 1,672.49 2,580.93 54.32
3. ANGOLA 4,513.52 5,689.09 26.05 1,216.51 1,492.25 22.67
4. GHANA 3,451.36 3,535.00 2.42 949.50 676.74 -28.73
5. USA 10,677.39 3,164.47 -70.36 268.52 173.66 -35.32
6. UNSPECIFIED 1.24 3,149.08 254,865.77 0.03 0.75 2,393.33
7. RUSSIA 2,895.35 3,085.07 6.55 78.13 119.23 52.60
8. TANZANIA REP 1,972.02 2,969.37 50.57 628.68 547.08 -12.98
9. SRI LANKA DSR 2,091.24 2,742.18 31.13 321.98 318.56 -1.06
10. ZAMBIA 2,605.63 1,799.76 -30.93 219.44 291.33 32.76
11. SOUTH AFRICA 2,391.89 1,702.17 -28.84 140.98 54.57 -61.29
12. UKRAINE 457.11 1,695.94 271.02 52.35 57.35 9.54
13. CAMBODIA 243.61 1,601.14 557.26 22.89 54.79 139.39
14. UGANDA 233.57 1,592.05 581.62 33.99 59.56 75.22
15. LESOTHO 461.76 1,587.91 243.88 15.39 224.68 1,360.17
16. UK 3,991.61 1,541.46 -61.38 348.11 137.50 -60.50
17. VIETNAM SOC REP 1,762.87 1,523.91 -13.56 123.55 113.11 -8.45
18. ROMANIA 1,138.52 1,310.41 15.10 22.94 35.67 55.47
19. ZIMBABWE 3,266.55 1,294.82 -60.36 131.96 30.51 -76.88
20. U ARAB EMTS 739.60 1,254.62 69.64 132.24 106.87 -19.18
21. MYANMAR 1,246.82 1,221.05 -2.07 173.92 141.30 -18.75
22. UZBEKISTAN 576.59 1,191.97 106.73 110.25 121.31 10.03
23. THAILAND 1,626.03 1,189.36 -26.86 75.62 48.29 -36.15
24. CONGO D. REP. 3,355.33 1,063.85 -68.29 582.30 95.08 -83.67
25. FRANCE 213.28 1,062.92 398.37 53.96 216.22 300.74
26. MAURITIUS 1,158.93 1,046.16 -9.73 20.31 12.62 -37.86
27. NEPAL 677.38 1,030.06 52.06 66.21 98.49 48.74
28. IRAN 808.23 971.79 20.24 68.79 16.01 -76.73
29. NIGER 591.84 924.29 56.17 146.35 131.68 -10.02
30. BRAZIL 1,105.66 919.55 -16.83 25.38 40.47 59.43
31. MALAWI 75.50 912.03 1,107.98 10.60 45.83 332.47
32. NETHERLAND 778.11 879.70 13.06 97.25 96.67 -0.60
33. BELGIUM 416.58 777.19 86.57 27.20 56.09 106.24
34. EGYPT A RP 1.81 753.12 41,433.37 0.37 94.50 25,579.35
35. KENYA 606.93 737.98 21.59 50.90 47.14 -7.38
36. AFGHANISTAN TIS 991.39 689.82 -30.42 245.57 167.94 -31.61
37. CHILE 47.11 682.15 1,347.92 1.27 38.23 2,898.67
38. SINGAPORE 2,563.40 612.65 -76.10 54.22 14.79 -72.72
39. TAJIKISTAN 139.80 480.48 243.70 33.75 70.39 108.55
40. C AFRI REP 463.11 472.32 1.99 160.71 117.94 -26.61
41. SUDAN 538.54 401.53 -25.44 64.83 44.03 -32.08
42. SWEDEN 98.13 393.86 301.36 13.75 22.96 66.95
43. AUSTRALIA 843.96 393.31 -53.40 75.01 31.50 -58.01
44. LIBYA 42.71 388.22 808.92 1.90 25.33 1,233.16
45. PHILIPPINES 608.28 383.24 -37.00 58.17 20.73 -64.37
46. DOMINIC REP 652.45 358.00 -45.13 18.21 36.50 100.50
47. KAZAKHSTAN 117.39 349.90 198.07 3.92 43.67 1,012.92
48. VENEZUELA 705.06 289.99 -58.87 12.77 9.62 -24.67
49. HAITI 566.38 286.21 -49.47 47.21 10.06 -78.69
50. GUINEA 251.74 285.37 13.36 59.65 59.11 -0.90
51. YEMEN REPUBLC 221.84 273.12 23.12 42.13 25.10 -40.43
52. SOMALIA 172.37 269.74 56.49 54.94 62.47 13.69
53. BURUNDI 58.81 247.02 320.01 4.99 13.24 165.55
54. NORWAY 327.13 235.64 -27.97 39.69 18.33 -53.82
55. MOZAMBIQUE 2,079.90 228.20 -89.03 61.50 25.99 -57.73
56. GERMANY 1,078.38 225.59 -79.08 45.30 17.10 -62.25
57. DENMARK 102.28 221.25 116.32 7.18 18.52 158.01
58. ETHIOPIA 231.42 207.66 -10.27 36.41 43.59 19.72
59. HUNGARY 84.33 206.53 144.92 5.00 11.00 120.00
60. CHAD 262.39 201.98 -23.02 47.09 7.53 -84.02
61. CANADA 121.20 193.56 59.71 19.94 10.15 -49.10
62. COTE D' IVOIRE 506.84 181.02 -64.28 16.69 7.17 -57.06
63. CUBA 105.09 180.60 71.86 3.37 8.01 137.97
64. BURKINA FASO 49.86 168.09 237.13 9.37 35.75 281.70
65. LEBANON 169.95 162.88 -4.16 1.56 1.83 17.08
66. JORDAN 82.44 159.34 93.28 8.00 11.60 45.00
67. SIERRA LEONE 206.07 157.35 -23.64 58.02 31.51 -45.68
68. IRAQ 20.44 131.15 541.49 3.20 5.88 83.49
69. IRELAND 7.59 131.11 1,627.33 0.19 8.54 4,279.49
70. CAMEROON 363.72 130.80 -64.04 59.52 12.14 -79.61
71. NEW ZEALAND 226.92 126.53 -44.24 14.13 5.86 -58.55
72. PERU 202.01 125.88 -37.69 8.77 3.72 -57.61
73. GUYANA 65.20 122.81 88.34 10.76 9.32 -13.43
74. BOLIVIA 70.67 121.62 72.10 9.49 3.11 -67.27
75. LATVIA 112.47 111.91 -0.50 32.41 17.98 -44.52
76. TOGO 685.02 109.68 -83.99 44.60 22.12 -50.41
77. AUSTRIA 4.95 103.95 2,000.02 0.49 5.40 1,006.56
78. SEYCHELLES 137.31 102.44 -25.40 1.84 1.66 -9.48
79. BELIZE 47.18 92.44 95.95 0.68 1.48 118.44
80. TURKMENISTAN 99.53 91.14 -8.43 11.94 8.85 -25.92
81. NAMIBIA 1,241.50 90.27 -92.73 25.31 4.19 -83.45
82. SWAZILAND 112.29 87.10 -22.43 11.15 5.51 -50.64
83. KYRGHYZSTAN 66.48 83.42 25.48 7.14 13.49 88.93
84. GUATEMALA 106.87 79.65 -25.47 6.03 4.53 -24.89
85. PAPUA N GNA 116.93 78.25 -33.08 4.14 2.67 -35.46
86. BOTSWANA 98.06 77.49 -20.97 6.40 2.54 -60.33
87. AZERBAIJAN 17.02 69.42 307.97 1.61 10.80 569.98
88. VANUATU REP 219.38 65.98 -69.92 1.98 1.95 -1.87
89. MALI 101.27 64.59 -36.22 7.82 4.56 -41.69
90. MOROCCO 1.72 64.23 3,627.32 0.15 3.93 2,522.67
91. BARBADOS 88.07 63.87 -27.47 2.40 1.71 -29.02
92. SENEGAL 7.95 63.42 698.25 0.50 0.95 90.00
93. BULGARIA 62.77 1.25
94. BENIN 257.96 61.97 -75.98 36.98 13.66 -63.07
95. RWANDA 86.88 61.34 -29.39 3.73 3.26 -12.58
96. MADAGASCAR 164.85 59.22 -64.08 36.70 17.52 -52.26
97. MAURITANIA 66.02 59.05 -10.56 6.92 1.72 -75.20
98. MALAYSIA 74.54 57.05 -23.47 5.13 6.29 22.67
99. BAHAMAS 41.12 56.39 37.12 1.80 1.86 3.33
100. LIBERIA 112.57 55.15 -51.01 19.60 16.01 -18.35
102. TURKEY 11.15 49.07 340.03 0.20 1.36 577.61
103. GEORGIA 69.51 48.67 -29.98 12.70 7.95 -37.44
104. PARAGUAY 18.48 48.06 160.09 0.89 0.78 -12.19
105. GABON 24.03 44.69 85.99 0.31 0.87 181.29
106. PORTUGAL 17.67 43.35 145.42 1.65 4.94 199.03
107. EQUTL GUINEA 31.81 43.06 35.39 1.08 1.43 32.65
108. BELARUS 21.76 41.43 90.39 0.33 0.36 7.88
109. HONG KONG 27.54 40.07 45.49 1.57 2.27 44.22
110. SURINAME 42.83 39.13 -8.62 1.63 0.66 -59.39
111. COLOMBIA 383.91 38.64 -89.94 25.66 1.50 -94.15
112. BANGLADESH PR 1,130.96 37.31 -96.70 19.91 1.82 -90.88
113. CAPE VERDE IS 36.76 0.79
114. ALGERIA 112.41 36.46 -67.57 5.61 0.56 -90.02
115. MALDIVES 65.55 32.91 -49.80 8.95 6.82 -23.84
116. HONDURAS 12.46 30.52 144.92 2.12 2.95 39.58
117. PANAMA REPUBLIC 60.11 29.35 -51.18 11.02 1.28 -88.38
118. SPAIN 18.31 26.18 43.00 1.20 0.60 -50.00
119. JAPAN 2.16 25.90 1,100.79 0.00 0.50 24,900.00
120. PAKISTAN IR 51.59 25.54 -50.49 6.76 1.50 -77.81
121. CROATIA 25.49 3.10
122. JAMAICA 27.13 24.46 -9.86 1.79 0.24 -86.36
123. COSTA RICA 31.96 22.81 -28.62 8.55 1.94 -77.30
124. NICARAGUA 18.32 2.45
125. TRINIDAD 27.31 17.09 -37.44 2.45 2.09 -14.89
126. MACEDONIA 0.90 16.25 1,701.90 0.02 0.16 742.11
127. CHINA P RP 24.84 16.07 -35.32 3.02 0.56 -81.46
128. BAHARAIN IS 15.91 0.43
130. SLOVENIA 0.22 13.95 6,321.50 0.03 1.25 4,707.69
131. GAMBIA 50.15 13.90 -72.27 11.15 1.13 -89.86
132. ALBANIA 1.23 12.57 925.31 0.04 1.50 3,388.37
133. URUGUAY 16.28 12.26 -24.67 5.00 0.51 -89.80
134. MOLDOVA 8.52 12.11 42.03 0.06 0.54 801.67
135. LITHUANIA 0.81 9.75 1,102.17 0.22 1.27 474.66
136. CAYMAN IS 5.92 8.23 38.95 0.19 0.37 98.92
137. CZECH REPUBLIC 15.22 8.07 -46.95 1.12 0.62 -44.64
138. TIMOR LESTE 9.88 6.72 -31.94 0.04 1.07 2,954.29
139. SAMOA 17.45 5.69 -67.37 0.62 0.22 -64.74
140. EL SALVADOR 50.17 5.49 -89.05 1.01 0.14 -86.21
141. GRENADA 0.44 5.47 1,142.69 0.05 0.16 192.59
142. KIRIBATI REP 4.72 0.30
143. OMAN 1.36 4.49 229.84 0.05 0.21 366.67
144. ERITREA 3.83 4.14 8.22 0.95 0.15 -84.21
145. MONGOLIA 4.12 0.06
146. KOREA DP RP 3.60 1.90
147. ST VINCENT 0.79 3.45 337.15 0.03 0.04 25.00
148. SOLOMON IS 3.08 3.25 5.70 1.03 0.52 -49.37
149. ECUADOR 1.83 3.11 69.35 0.90 0.80 -11.11
150. POLAND 1.36 2.98 119.41 0.25 0.24 -4.80
151. GUADELOUPE 1.59 2.86 79.77 0.13 0.10 -23.08
152. ARMENIA 2.49 2.79 11.95 0.87 0.08 -90.78
153. DJIBOUTI 69.10 2.61 -96.23 10.99 0.05 -99.53
154. FINLAND 2.51 0.06
155. INDONESIA 162.61 1.48 -99.09 3.01 0.04 -98.67
156. DOMINICA 1.47 0.06
157. KUWAIT 1.34 0.15
158. ST LUCIA 0.34 1.09 224.87 0.01 0.14 800.00
159. LAO PD RP 0.94 0.03
160. FIJI IS 7.46 0.83 -88.83 0.37 0.04 -89.19
161. QATAR 0.37 0.02
162. GUINEA BISSAU 0.35 0.00
163. KOREA RP 66.33 0.34 -99.49 2.08 0.01 -99.61
164. ANTIGUA 0.09 0.32 248.42 0.00 0.04 620.00
165. CYPRUS 0.23 0.00
166. SYRIA 0.19 0.01
167. GUAM 0.11 0.01
168. ARGENTINA 9.32 0.25
169. ANGUILLA 1.67 0.01
170. TAIWAN 1.57 0.47
171. BR VIRGN IS 7.44 0.14
172. MACAO 0.37 0.04
173. MALTA 4.33 0.21
174. ISRAEL 1.42 0.40
175. ITALY 18.09 1.76
176. SAUDI ARAB 3.65 0.71
177. UNION OF SERBIA & 7.70 0.20
MONTENEGRO
178. SLOVAK REP 0.46 0.05
179. MEXICO 63.04 10.74
180. ST KITT N A 0.15 0.01
181. TUNISIA 2.16 0.05
Total 93,801.41 92,589.91 -1.29
Approximate amount of import to India
Commodity: 30045090 OTHERS PUT UP FOR RETAIL SALE Unit: KGS

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. USA 470.85 1,405.71 198.55 0.63 3.24 418.37
2. SWITZERLAND 295.16 299.72 1.54 1.15 0.17 -85.39
3. AUSTRALIA 281.26 137.97 -50.95 0.43 0.10 -76.64
4. BELGIUM 7.65 0.00
5. CANADA 0.11 4.62 4,107.01 0.00 0.00 100.00
6. JAPAN 2.23 0.00
7. ROMANIA 1.79 0.00
8. SINGAPORE 1.15 0.00
9. FRANCE 0.01 1.02 6,967.36 0.00
10. GERMANY 0.01 1.00 16,576.67 0.00
11. CHILE 0.87 0.00
12. IRELAND 0.83 0.00
13. U K 0.83 0.46 -44.05 0.00 0.00 100.00
14. BRAZIL 0.30
15. SPAIN 0.20 0.00
18. CHINA P RP 5.93 0.00
19. SOUTH AFRICA 0.08
Total 1,074.43 1,865.52 73.63
Approximate amount of Export Country wise
Countries: Nigeria, Congo, Angola, Ghana, USA, Russia, Tanzania, Sri Lanka, Zambia,
South Africa, Ukraine, Cambodia, Uganda, Lesotho, UK
Region: USA, Africa, CIS, Neighboring countries, Cambodia, UK
9. MORE D3 SACHET
Contents: Cholecalciferol 60000 IU Sachet

Basic Information: Cholecalciferol (toxiferol, vitamin D3) is one of the five forms of
vitamin D. It is a secosteroid, that is, a steroid molecule with one ring open. This and all
forms of vitamin D are misnamed: vitamins by definition are essential organic
compounds which cannot be synthesized by the body and must be ingested;
cholecalciferol is synthesized by the body, and functions as a prehormone.
Cholecalciferol is inactive: it is converted to its active form by two hydroxylations: the
first in the liver, the second in the kidney, to form calcitriol, whose action is mediated by
the vitamin D receptor, anuclear receptor which regulates the synthesis of hundreds of
enzymes and is present in virtually every cell in the body.
Indications: Vitamin D3 supplement, to absorb Calcium

Branches: Ortho, GP, Pediatrics, Gynecology
HS Code: 30049099
Duty Drawback: -
HS Code: 30049099

300490  Other
3004099  Other

Duty Drawback: -

2012- 2013-
2012-2013 2013-2014 %Growth %Growth
2013 2014
1. USA 692,553.76 828,084.65 19.57 16,310.52 19,455.86 19.28
2. SOUTH AFRICA 107,628.55 198,417.36 84.35 2,633.03 4,843.38 83.95
3. RUSSIA 80,764.08 80,041.31 -0.89 3,280.55 2,361.99 -28.00
4. KENYA 70,077.96 76,782.37 9.57 2,768.15 2,407.90 -13.01
5. UK 55,884.64 62,434.13 11.72 3,558.03 5,489.30 54.28
6. NIGERIA 52,472.96 56,984.23 8.60 4,042.26 4,795.31 18.63
7. ZAMBIA 19,701.08 55,560.87 182.02 794.29 2,089.91 163.12
8. TANZANIA REP 38,027.79 50,004.74 31.50 1,284.99 2,744.00 113.54
9. UGANDA 30,262.34 47,987.67 58.57 1,190.51 1,751.19 47.10
10. GHANA 56,141.32 46,168.09 -17.76 3,094.27 3,171.20 2.49
11. CANADA 31,881.57 41,182.96 29.17 815.53 1,077.41 32.11
12. SRI LANKA DSR 30,895.57 37,907.46 22.70 2,186.07 2,524.10 15.46
13. GERMANY 46,706.23 36,989.36 -20.80 1,927.99 1,271.13 -34.07
14. ETHIOPIA 15,020.06 36,568.94 143.47 853.71 1,313.47 53.85
15. VIETNAM SOC REP 27,327.31 36,263.41 32.70 1,202.69 1,404.40 16.77
16. BRAZIL 33,577.30 33,090.45 -1.45 803.64 1,049.39 30.58
17. MYANMAR 22,465.71 32,790.88 45.96 1,660.65 1,870.17 12.62
18. UNSPECIFIED 6,138.44 29,545.73 381.32 94.57 491.57 419.81
19. PHILIPPINES 19,145.90 28,673.70 49.76 998.81 1,590.13 59.20
20. MALAWI 25,234.16 28,303.11 12.16 532.34 625.89 17.57
21. JAPAN 23,909.62 24,776.30 3.62 160.99 253.59 57.52
22. AUSTRALIA 23,028.79 24,576.59 6.72 1,190.70 1,148.50 -3.54
23. NETHERLAND 19,180.21 22,501.54 17.32 1,144.77 1,224.94 7.00
24. VENEZUELA 16,563.35 21,942.59 32.48 340.02 287.80 -15.36
25. FRANCE 18,707.79 21,177.94 13.20 1,087.64 1,204.06 10.70
26. ZIMBABWE 29,898.61 20,515.59 -31.38 991.70 551.07 -44.43
27. IRAN 14,891.06 19,839.02 33.23 531.42 461.85 -13.09
28. SLOVENIA 20,339.89 17,508.55 -13.92 180.81 170.34 -5.79
29. ANGOLA 8,500.99 17,469.38 105.50 1,933.87 1,971.35 1.94
30. BOTSWANA 13,954.67 17,043.56 22.14 407.31 408.35 0.25
31. MOZAMBIQUE 7,947.14 15,172.17 90.91 732.37 692.88 -5.39
32. THAILAND 14,726.30 14,322.03 -2.75 1,672.08 1,005.01 -39.89
33. BELGIUM 13,027.95 14,025.69 7.66 665.20 550.16 -17.29
34. UKRAINE 19,432.23 12,398.75 -36.19 1,318.39 649.37 -50.75
35. CAMEROON 6,333.50 12,136.34 91.62 561.95 515.07 -8.34
36. IRAQ 12,173.59 11,765.81 -3.35 964.35 3,642.48 277.71
37. BENIN 11,953.74 11,722.43 -1.94 1,788.94 1,343.02 -24.93
38. HUNGARY 9,147.12 11,487.78 25.59 303.45 175.60 -42.13
39. CONGO D. REP. 6,115.45 10,252.13 67.64 502.51 1,229.01 144.57
40. YEMEN REPUBLC 6,878.69 10,140.96 47.43 1,010.14 1,772.73 75.49
41. MALAYSIA 7,093.54 9,305.41 31.18 402.45 426.86 6.07
42. CHILE 9,364.61 9,287.44 -0.82 745.97 639.37 -14.29
43. CAMBODIA 4,940.22 9,075.52 83.71 1,637.75 1,112.61 -32.06
44. RWANDA 5,274.90 8,958.96 69.84 181.94 187.81 3.23
45. COLOMBIA 10,634.06 8,891.37 -16.39 290.98 537.15 84.60
46. SUDAN 5,955.72 8,848.51 48.57 317.13 561.60 77.09
47. KAZAKHSTAN 8,566.42 8,788.84 2.60 483.63 191.86 -60.33
48. MAURITIUS 6,362.29 8,718.65 37.04 338.15 381.41 12.79
49. ALGERIA 6,990.44 8,475.57 21.25 246.52 142.05 -42.38
50. BURKINA FASO 6,602.24 8,286.73 25.51 234.85 436.23 85.75
51. SINGAPORE 8,193.92 8,065.20 -1.57 475.96 239.43 -49.69
52. GUINEA 4,682.58 8,041.54 71.73 622.25 903.08 45.13
53. NIGER 4,657.54 7,906.28 69.75 609.26 1,039.53 70.62
54. U ARAB EMTS 4,518.91 7,257.22 60.60 321.82 485.60 50.89
55. DOMINIC REP 5,787.79 7,138.46 23.34 225.63 414.31 83.63
56. NEPAL 6,565.37 7,017.53 6.89 897.20 814.67 -9.20
57. LESOTHO 5,479.46 6,818.41 24.44 134.62 145.61 8.17
58. FINLAND 4,357.09 6,712.84 54.07 134.57 190.79 41.77
59. NAMIBIA 7,858.40 6,678.66 -15.01 170.48 305.54 79.23
60. NEW ZEALAND 4,387.30 6,029.27 37.43 271.56 334.58 23.20
61. ROMANIA 6,464.86 5,849.62 -9.52 153.07 131.42 -14.14
62. PERU 3,785.22 5,669.78 49.79 180.02 211.58 17.53
63. UZBEKISTAN 4,289.60 5,527.91 28.87 361.67 475.50 31.47
64. SPAIN 5,563.67 5,422.09 -2.54 373.76 217.96 -41.69
65. IRELAND 6,503.02 5,391.93 -17.09 289.74 429.08 48.09
66. JAMAICA 3,224.90 5,373.65 66.63 141.54 160.43 13.35
67. TURKMENISTAN 2,554.22 5,132.02 100.92 296.40 896.12 202.34
68. CONGO P REP 4,795.18 4,859.18 1.33 378.55 569.36 50.41
69. AFGHANISTAN TIS 3,590.56 4,802.71 33.76 1,235.67 716.39 -42.02
70. MALTA 4,624.39 4,739.99 2.50 240.15 214.20 -10.81
71. PORTUGAL 3,470.45 4,396.44 26.68 217.10 391.65 80.40
72. TAJIKISTAN 1,261.74 4,376.60 246.87 217.67 1,003.39 360.98
73. TOGO 3,393.99 4,324.64 27.42 417.86 311.77 -25.39
74. POLAND 5,883.06 4,301.39 -26.89 56.92 67.09 17.88
75. MOROCCO 2,848.00 4,220.51 48.19 71.84 65.72 -8.52
76. INDONESIA 1,878.31 4,098.59 118.21 343.50 516.88 50.47
77. SWAZILAND 6,849.66 4,056.04 -40.78 97.21 123.00 26.53
78. MEXICO 4,289.44 3,990.79 -6.96 150.44 135.18 -10.14
79. DENMARK 3,831.75 3,951.15 3.12 331.70 316.31 -4.64
80. HONG KONG 2,911.00 3,798.20 30.48 58.64 96.98 65.40
81. SWITZERLAND 3,019.41 3,752.81 24.29 168.06 75.26 -55.22
82. JORDAN 2,768.18 3,280.50 18.51 283.69 414.99 46.28
83. LEBANON 1,207.23 3,275.83 171.35 22.55 112.69 399.79
84. CHAD 2,265.74 3,254.05 43.62 153.97 180.82 17.44
85. BURUNDI 2,489.06 3,137.37 26.05 131.76 207.67 57.62
86. ITALY 3,861.46 3,080.80 -20.22 156.97 153.54 -2.19
87. SYRIA 1,989.47 2,985.12 50.05 56.29 1,311.66 2,230.15
88. CUBA 1,421.71 2,971.76 109.03 70.01 88.01 25.72
89. TURKEY 2,353.69 2,951.16 25.38 118.07 93.07 -21.17
90. KOREA RP 1,685.57 2,879.49 70.83 86.07 37.00 -57.01
91. CROATIA 2,926.87 2,866.50 -2.06 36.35 56.72 56.00
92. LIBYA 3,210.74 2,838.07 -11.61 293.09 241.72 -17.53
93. PAKISTAN IR 1,364.86 2,736.90 100.53 100.56 259.15 157.72
94. HAITI 3,327.33 2,729.73 -17.96 264.45 203.85 -22.92
95. MALDIVES 2,272.90 2,676.02 17.74 229.27 142.29 -37.94
96. PAPUA N GNA 1,699.71 2,655.24 56.22 507.83 271.15 -46.60
97. SWEDEN 1,909.81 2,643.73 38.43 84.61 162.15 91.66
98. TRINIDAD 2,049.75 2,581.34 25.93 133.08 107.03 -19.58
99. COSTA RICA 2,282.97 2,532.01 10.91 101.12 114.65 13.39
100. CZECH REPUBLIC 3,572.13 2,511.72 -29.69 69.92 102.86 47.12
101. MALI 2,823.88 2,481.35 -12.13 274.63 245.32 -10.67
102. SENEGAL 1,278.75 2,443.26 91.07 109.32 164.20 50.20
103. SOMALIA 1,219.63 2,442.00 100.23 412.96 424.46 2.79
104. LITHUANIA 1,332.39 2,418.36 81.50 49.66 76.08 53.18
105. ECUADOR 2,389.88 2,414.93 1.05 31.49 53.76 70.75
106. GUATEMALA 2,045.46 2,400.80 17.37 120.07 197.60 64.58
107. BELARUS 1,800.56 2,375.29 31.92 51.42 69.21 34.62
108. COTE D' IVOIRE 1,950.37 2,219.84 13.82 176.80 104.33 -40.99
109. PANAMA REPUBLIC 2,338.05 2,122.79 -9.21 71.16 77.59 9.04
110. BULGARIA 1,573.47 2,066.15 31.31 50.13 75.87 51.34
111. SIERRA LEONE 1,671.71 1,898.23 13.55 635.47 251.41 -60.44
112. MADAGASCAR 2,091.06 1,890.17 -9.61 296.13 186.50 -37.02
113. LATVIA 986.52 1,874.87 90.05 123.82 147.18 18.87
114. GUYANA 1,514.10 1,855.33 22.54 110.13 161.21 46.39
115. EL SALVADOR 1,734.62 1,836.62 5.88 115.64 152.59 31.96
116. ERITREA 996.78 1,813.21 81.91 78.97 94.44 19.59
117. GEORGIA 1,602.58 1,798.71 12.24 165.77 121.86 -26.49
118. AUSTRIA 2,747.78 1,771.75 -35.52 38.53 42.64 10.67
119. BOLIVIA 2,141.28 1,738.85 -18.79 243.16 98.77 -59.38
120. LIBERIA 1,622.98 1,606.53 -1.01 431.41 152.57 -64.63
121. GABON 1,308.66 1,569.82 19.96 46.05 32.20 -30.08
122. KYRGHYZSTAN 914.45 1,453.84 58.99 157.90 117.46 -25.61
123. OMAN 1,050.40 1,391.37 32.46 35.84 47.68 33.02
124. TAIWAN 758.20 1,250.84 64.98 13.65 19.49 42.73
125. NICARAGUA 1,540.09 1,205.88 -21.70 208.28 155.84 -25.18
126. C AFRI REP 1,419.97 1,146.73 -19.24 29.29 74.92 155.75
127. EGYPT A RP 1,173.87 1,127.16 -3.98 66.10 45.65 -30.93
128. CHINA P RP 747.07 1,126.88 50.84 18.09 51.68 185.69
129. SERBIA 1,124.10 8.47
130. MAURITANIA 419.18 1,027.62 145.15 58.64 131.51 124.27
131. UNION OF SERBIA & 1,483.07 1,026.94 -30.76 45.60 58.18 27.58
MONTENEGRO
132. MOLDOVA 967.09 956.49 -1.10 45.38 46.49 2.44
133. GAMBIA 554.55 953.30 71.91 81.77 74.10 -9.38
134. URUGUAY 1,361.38 952.69 -30.02 14.94 12.26 -17.96
135. VANUATU REP 1,062.00 952.37 -10.32 9.64 11.16 15.83
136. HONDURAS 2,773.69 827.07 -70.18 107.77 87.31 -18.99
137. ARGENTINA 651.59 820.23 25.88 5.60 11.44 104.16
138. AZERBAIJAN 1,451.50 791.54 -45.47 101.40 69.30 -31.66
139. SEYCHELLES 549.40 790.03 43.80 19.28 41.03 112.84
140. SAUDI ARAB 549.71 730.05 32.81 41.23 74.25 80.09
141. FIJI IS 702.67 633.50 -9.84 108.39 38.99 -64.03
142. CYPRUS 683.98 613.09 -10.36 12.05 17.41 44.44
143. BANGLADESH PR 804.09 592.66 -26.30 21.23 21.40 0.80
144. PARAGUAY 729.76 584.87 -19.85 20.48 10.71 -47.69
145. KOREA DP RP 521.52 478.88 -8.18 36.74 35.85 -2.41
146. SLOVAK REP 1,753.16 471.52 -73.10 24.36 9.35 -61.62
147. GUINEA BISSAU 263.05 441.41 67.80 19.11 36.00 88.35
148. BAHAMAS 466.69 412.48 -11.62 14.67 10.15 -30.80
149. BHUTAN 397.77 384.62 -3.31 35.51 108.86 206.54
151. MONGOLIA 223.26 351.14 57.28 16.39 29.20 78.22
152. BAHARAIN IS 427.79 347.19 -18.84 8.98 5.73 -36.21
153. SURINAME 155.89 344.39 120.92 8.37 7.94 -5.15
154. LAO PD RP 160.52 314.96 96.21 9.63 10.87 12.89
155. BOSNIA-HRZGOVIN 256.97 302.82 17.84 9.72 12.46 28.16
156. MACEDONIA 288.32 302.51 4.92 4.23 4.11 -2.77
157. EQUTL GUINEA 441.60 295.74 -33.03 57.52 31.80 -44.73
158. KUWAIT 122.60 287.74 134.69 9.81 19.78 101.72
159. ISRAEL 208.76 279.19 33.74 7.45 21.08 182.81
160. DJIBOUTI 192.69 271.73 41.02 39.83 8.04 -79.81
161. ARMENIA 123.86 234.24 89.11 11.06 12.82 15.99
162. GREECE 822.45 216.21 -73.71 39.71 6.05 -84.76
163. ST LUCIA 97.19 188.31 93.75 5.26 11.35 115.78
164. BARBADOS 616.58 131.34 -78.70 20.61 5.82 -71.75
165. MICRONESIA 90.81 101.34 11.60 1.88 3.67 95.37
166. BELIZE 141.73 97.32 -31.34 7.51 2.83 -62.26
167. FR GUIANA 85.08 1.30
168. QATAR 164.49 85.06 -48.29 14.84 8.58 -42.23
169. TONGA 19.55 80.00 309.30 0.19 12.42 6,576.34
170. SOLOMON IS 53.16 71.91 35.29 7.39 2.09 -71.66
171. COMOROS 13.72 70.17 411.31 1.30 36.06 2,682.41
172. ANTIGUA 52.77 65.67 24.45 1.30 1.34 2.85
173. CAYMAN IS 19.26 63.95 232.07 0.37 2.28 521.58
174. SAMOA 39.63 57.12 44.15 0.99 10.35 943.85
175. ESTONIA 184.33 51.87 -71.86 5.84 5.30 -9.20
176. MACAO 73.51 51.76 -29.59 3.22 1.25 -61.20
177. CAPE VERDE IS 29.07 48.20 65.83 0.39 1.13 190.75
178. ST KITT N A 38.86 43.06 10.80 0.95 2.03 114.24
179. TUNISIA 204.06 34.09 -83.29 1.89 0.79 -58.28
180. ST VINCENT 39.96 33.06 -17.28 0.83 0.78 -6.83
181. NORWAY 67.76 31.29 -53.82 10.77 1.05 -90.22
182. GRENADA 22.56 26.43 17.16 0.88 0.99 12.12
183. SAO TOME 14.62 26.07 78.27 0.23 0.76 234.21
184. MONTENEGRO 25.56 0.33
185. DOMINICA 326.29 23.11 -92.92 10.05 1.06 -89.45
186. ALBANIA 57.26 18.76 -67.23 1.77 0.48 -72.82
187. LUXEMBOURG 16.91 18.51 9.50 0.09 0.16 75.56
188. TIMOR LESTE 311.06 17.46 -94.39 14.21 2.18 -84.65
189. BR VIRGN IS 0.08 13.66 17,168.14 0.02 0.16 695.00
190. PALAU 16.00 12.14 -24.09 0.14 0.11 -18.84
191. KIRIBATI REP 3.50 11.70 234.44 0.90 0.68 -25.00
192. MARSHALL ISLAND 12.87 7.93 -38.35 0.33 0.25 -23.31
193. ICELAND 35.73 4.61 -87.09 0.55 0.32 -42.55
194. PUERTO RICO 0.42 4.38 954.08 0.02 0.25 1,150.00
195. BRUNEI 2.30 0.06
196. GUAM 103.37 2.02 -98.05 3.32 0.38 -88.57
197. MONTSERRAT 0.64 1.84 188.79 0.00 0.05 1,700.00
198. NAURU RP 1.76 0.03
199. ANGUILLA 1.03 1.70 64.98 0.03 0.03 -12.12
200. GIBRALTAR 1.67 0.04
201. TUVALU 0.44 0.03
202. REUNION 0.09 0.02
203. PANAMA C Z 0.02 0.00
Total 2,086,427.98 2,560,318.81 22.71

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. SWITZERLAND 42,316.70 43,137.38 1.94 43.75 57.57 31.61
2. GERMANY 26,205.81 35,640.97 36.00 21.43 97.39 354.53
3. USA 29,105.65 32,629.05 12.11 27.80 45.67 64.27
4. ITALY 25,638.39 23,354.98 -8.91 18.00 38.91 116.19
5. UK 18,735.12 21,618.33 15.39 16.37 39.12 139.00
6. FRANCE 18,984.63 15,853.37 -16.49 18.72 24.01 28.28
7. NETHERLAND 8,196.64 10,341.38 26.17 6.83 13.94 104.07
8. BELGIUM 5,680.04 6,602.63 16.24 9.81 8.71 -11.16
9. IRELAND 8,403.77 5,705.67 -32.11 5.06 7.09 39.93
10. CANADA 2,243.56 5,163.37 130.14 2.94 12.28 317.87
11. FINLAND 2,101.45 5,086.05 142.03 1.95 20.69 963.80
12. CHINA P RP 3,585.55 4,574.38 27.58 6.53 25.94 297.15
13. SWEDEN 3,824.99 4,515.30 18.05 5.26 21.88 315.74
14. DENMARK 4,560.32 4,265.60 -6.46 4.06 4.14 1.87
15. PUERTO RICO 2,065.22 3,915.67 89.60 1.33 7.16 439.59
16. MEXICO 2,126.68 2,740.39 28.86 2.58 2.90 12.57
17. JAPAN 5,269.03 2,334.33 -55.70 5.24 2.68 -48.92
18. SPAIN 1,775.61 1,589.65 -10.47 2.91 2.99 2.92
19. AUSTRALIA 888.58 1,549.93 74.43 1.64 2.13 30.24
20. AUSTRIA 2,214.01 1,486.62 -32.85 2.61 1.65 -36.75
21. SINGAPORE 1,025.68 1,312.70 27.98 1.16 2.64 126.44
22. SOUTH AFRICA 791.27 947.76 19.78 4.91 0.80 -83.75
23. KOREA RP 989.10 785.44 -20.59 0.91 0.88 -3.07
24. MALAYSIA 2,076.59 720.81 -65.29 2.13 18.88 785.19
25. HUNGARY 126.44 634.29 401.63 0.61 0.84 39.50
26. TAIWAN 75.77 521.65 588.45 0.07 0.74 909.59
27. BRAZIL 454.66 457.00 0.52 0.49 0.36 -26.83
28. MALTA 319.27 432.33 35.41 0.58 0.32 -45.42
29. UNSPECIFIED 96.37 270.73 180.91 0.40 0.20 -49.88
30. CZECH REPUBLIC 129.80 194.77 50.05 1.22 11.37 833.58
31. ISRAEL 405.25 188.96 -53.37 0.87 1.07 22.08
32. URUGUAY 114.54 0.11
33. TURKEY 192.09 108.00 -43.78 0.08 0.32 289.02
34. RUSSIA 3.86 95.18 2,363.20 0.00 0.08 1,400.00
35. POLAND 176.58 39.89 -77.41 0.16 0.08 -47.77
36. ARGENTINA 30.30 36.34 19.91 0.03 0.01 -75.86
37. SLOVAK REP 26.31 0.03
38. PHILIPPINES 39.95 21.95 -45.07 0.07 0.02 -72.60
39. BULGARIA 4.33 21.93 406.41 0.00 0.02 375.00
40. PORTUGAL 29.63 20.98 -29.18 0.04 0.02 -46.34
41. HONG KONG 114.69 18.48 -83.89 0.11 0.01 -90.83
42. THAILAND 6.72 14.58 116.99 0.01 0.01 0.00
43. CYPRUS 3.83 12.47 225.47 0.00 0.02 325.00
44. LITHUANIA 11.05 0.01
45. U ARAB EMTS 10.46 10.21 -2.40 0.00 0.01 20.00
46. NEW ZEALAND 7.69 6.60 -14.24 0.01 0.01 100.00
47. MALDIVES 6.03 0.01
48. CHILE 63.37 5.01 -92.09 1.04 0.00 -99.52
49. LIBERIA 4.84 0.00
50. GREECE 7.85 2.38 -69.73 0.01 0.01 -46.15
52. ICELAND 15.80 1.84 -88.37 0.01 0.00 -70.00
53. SLOVENIA 21.89 1.82 -91.70 0.09 0.00 -97.73
55. INDONESIA 0.99 1.00 1.22 0.00 0.00 0.00
56. LATVIA 6.21 0.97 -84.42 0.01 0.00 -87.50
57. ROMANIA 11.08 0.79 -92.84 0.01 0.01 -53.85
58. MOROCCO 0.10 0.62 546.69 0.00 0.01 175.00
59. GEORGIA 0.42 0.00
60. KENYA 0.38 0.14 -62.49 0.00
61. CROATIA 0.05 0.02 -58.08
62. COSTA RICA 0.02
63. ALGERIA 0.54 0.00
65. GABON 0.30
66. JORDAN 0.09
67. JAMAICA 0.69
68. KOREA DP RP 6.35 0.00
69. NAMIBIA 0.51
71. PERU 42.03 0.04
72. SAUDI ARABIA 1.18 0.01
74. SWAZILAND 57.13 0.04
75. VENEZUELA 3.37
76. ZAMBIA 1.61 0.00
77. UKRAINE 0.16
Total 221,274.41 239,159.18 8.08
Countries: USA, South Africa, Russia, Kenya, UK, Nigeria, Zambia, Tanzania, Uganda,
Ghana, Canada, Sri Lanka, Germany, Ethiopia, Vietnam
Region: N.America, Africa, Russia, West Europe, Far East Asia
10. D COR 6 TAB
Contents: Deflazacort 6 mg tablet

Indications: Gluco corticoid, anti inflammatory, immuno suppression
Speciality: Orthopedic, GP
Basic Information: Deflazacort is a glucocorticoid used as an anti
inflammatory and immunosuppressant. Deflazacort is an inactive prodrug which
is metabolized rapidly to the active drug 21-desacetyldeflazacort. Its potency is around
70–90% that of prednisone.
HS Code: 30049099

300490  Other
30049099  Other

Duty Drawback: -

N.E.S Unit: KGS
%Grow 2012- 2013- %Grow

2012-2013 2013-2014
th 2013 2014 th
1. USA 692,553.7 828,084.6 19.57 16,310. 19,455. 19.28
6 5 52 86
2. SOUTH AFRICA 107,628.5 198,417.3 84.35 2,633.0 4,843.3 83.95
5 6 3 8
3. RUSSIA 80,764.08 80,041.31 -0.89 3,280.5 2,361.9 -28.00
5 9
4. KENYA 70,077.96 76,782.37 9.57 2,768.1 2,407.9 -13.01
5 0
5. UK 55,884.64 62,434.13 11.72 3,558.0 5,489.3 54.28
3 0
6. NIGERIA 52,472.96 56,984.23 8.60 4,042.2 4,795.3 18.63
6 1
7. ZAMBIA 19,701.08 55,560.87 182.02 794.29 2,089.9 163.12
1
8. TANZANIA REP 38,027.79 50,004.74 31.50 1,284.9 2,744.0 113.54
9 0
9. UGANDA 30,262.34 47,987.67 58.57 1,190.5 1,751.1 47.10
1 9
10. GHANA 56,141.32 46,168.09 -17.76 3,094.2 3,171.2 2.49
7 0
11. CANADA 31,881.57 41,182.96 29.17 815.53 1,077.4 32.11
1
12. SRI LANKA DSR 30,895.57 37,907.46 22.70 2,186.0 2,524.1 15.46
7 0
13. GERMANY 46,706.23 36,989.36 -20.80 1,927.9 1,271.1 -34.07
9 3
14. ETHIOPIA 15,020.06 36,568.94 143.47 853.71 1,313.4 53.85
7
15. VIETNAM SOC 27,327.31 36,263.41 32.70 1,202.6 1,404.4 16.77
REP 9 0
16. BRAZIL 33,577.30 33,090.45 -1.45 803.64 1,049.3 30.58
9
17. MYANMAR 22,465.71 32,790.88 45.96 1,660.6 1,870.1 12.62
5 7
18. UNSPECIFIED 6,138.44 29,545.73 381.32 94.57 491.57 419.81
19. PHILIPPINES 19,145.90 28,673.70 49.76 998.81 1,590.1 59.20
3
20. MALAWI 25,234.16 28,303.11 12.16 532.34 625.89 17.57
21. JAPAN 23,909.62 24,776.30 3.62 160.99 253.59 57.52
22. AUSTRALIA 23,028.79 24,576.59 6.72 1,190.7 1,148.5 -3.54
0 0
23. NETHERLAND 19,180.21 22,501.54 17.32 1,144.7 1,224.9 7.00
7 4
24. VENEZUELA 16,563.35 21,942.59 32.48 340.02 287.80 -15.36
25. FRANCE 18,707.79 21,177.94 13.20 1,087.6 1,204.0 10.70
4 6
26. ZIMBABWE 29,898.61 20,515.59 -31.38 991.70 551.07 -44.43
27. IRAN 14,891.06 19,839.02 33.23 531.42 461.85 -13.09
28. SLOVENIA 20,339.89 17,508.55 -13.92 180.81 170.34 -5.79
29. ANGOLA 8,500.99 17,469.38 105.50 1,933.8 1,971.3 1.94
7 5
30. BOTSWANA 13,954.67 17,043.56 22.14 407.31 408.35 0.25
31. MOZAMBIQUE 7,947.14 15,172.17 90.91 732.37 692.88 -5.39
32. THAILAND 14,726.30 14,322.03 -2.75 1,672.0 1,005.0 -39.89
8 1
33. BELGIUM 13,027.95 14,025.69 7.66 665.20 550.16 -17.29
34. UKRAINE 19,432.23 12,398.75 -36.19 1,318.3 649.37 -50.75
9
35. CAMEROON 6,333.50 12,136.34 91.62 561.95 515.07 -8.34
36. IRAQ 12,173.59 11,765.81 -3.35 964.35 3,642.4 277.71
8
37. BENIN 11,953.74 11,722.43 -1.94 1,788.9 1,343.0 -24.93
4 2
38. HUNGARY 9,147.12 11,487.78 25.59 303.45 175.60 -42.13
39. CONGO D. REP. 6,115.45 10,252.13 67.64 502.51 1,229.0 144.57
1
40. YEMEN 6,878.69 10,140.96 47.43 1,010.1 1,772.7 75.49
REPUBLC 4 3
41. MALAYSIA 7,093.54 9,305.41 31.18 402.45 426.86 6.07
42. CHILE 9,364.61 9,287.44 -0.82 745.97 639.37 -14.29
43. CAMBODIA 4,940.22 9,075.52 83.71 1,637.7 1,112.6 -32.06
5 1
44. RWANDA 5,274.90 8,958.96 69.84 181.94 187.81 3.23
45. COLOMBIA 10,634.06 8,891.37 -16.39 290.98 537.15 84.60
46. SUDAN 5,955.72 8,848.51 48.57 317.13 561.60 77.09
47. KAZAKHSTAN 8,566.42 8,788.84 2.60 483.63 191.86 -60.33
48. MAURITIUS 6,362.29 8,718.65 37.04 338.15 381.41 12.79
49. ALGERIA 6,990.44 8,475.57 21.25 246.52 142.05 -42.38
50. BURKINA FASO 6,602.24 8,286.73 25.51 234.85 436.23 85.75
51. SINGAPORE 8,193.92 8,065.20 -1.57 475.96 239.43 -49.69
52. GUINEA 4,682.58 8,041.54 71.73 622.25 903.08 45.13
53. NIGER 4,657.54 7,906.28 69.75 609.26 1,039.5 70.62
3
54. U ARAB EMTS 4,518.91 7,257.22 60.60 321.82 485.60 50.89
55. DOMINIC REP 5,787.79 7,138.46 23.34 225.63 414.31 83.63
56. NEPAL 6,565.37 7,017.53 6.89 897.20 814.67 -9.20
57. LESOTHO 5,479.46 6,818.41 24.44 134.62 145.61 8.17
58. FINLAND 4,357.09 6,712.84 54.07 134.57 190.79 41.77
59. NAMIBIA 7,858.40 6,678.66 -15.01 170.48 305.54 79.23
60. NEW ZEALAND 4,387.30 6,029.27 37.43 271.56 334.58 23.20
61. ROMANIA 6,464.86 5,849.62 -9.52 153.07 131.42 -14.14
62. PERU 3,785.22 5,669.78 49.79 180.02 211.58 17.53
63. UZBEKISTAN 4,289.60 5,527.91 28.87 361.67 475.50 31.47
64. SPAIN 5,563.67 5,422.09 -2.54 373.76 217.96 -41.69
65. IRELAND 6,503.02 5,391.93 -17.09 289.74 429.08 48.09
66. JAMAICA 3,224.90 5,373.65 66.63 141.54 160.43 13.35
67. TURKMENISTAN 2,554.22 5,132.02 100.92 296.40 896.12 202.34
68. CONGO P REP 4,795.18 4,859.18 1.33 378.55 569.36 50.41
69. AFGHANISTAN 3,590.56 4,802.71 33.76 1,235.6 716.39 -42.02
TIS 7
70. MALTA 4,624.39 4,739.99 2.50 240.15 214.20 -10.81
71. PORTUGAL 3,470.45 4,396.44 26.68 217.10 391.65 80.40
72. TAJIKISTAN 1,261.74 4,376.60 246.87 217.67 1,003.3 360.98
9
73. TOGO 3,393.99 4,324.64 27.42 417.86 311.77 -25.39
74. POLAND 5,883.06 4,301.39 -26.89 56.92 67.09 17.88
75. MOROCCO 2,848.00 4,220.51 48.19 71.84 65.72 -8.52
76. INDONESIA 1,878.31 4,098.59 118.21 343.50 516.88 50.47
77. SWAZILAND 6,849.66 4,056.04 -40.78 97.21 123.00 26.53
78. MEXICO 4,289.44 3,990.79 -6.96 150.44 135.18 -10.14
79. DENMARK 3,831.75 3,951.15 3.12 331.70 316.31 -4.64
80. HONG KONG 2,911.00 3,798.20 30.48 58.64 96.98 65.40
81. SWITZERLAND 3,019.41 3,752.81 24.29 168.06 75.26 -55.22
82. JORDAN 2,768.18 3,280.50 18.51 283.69 414.99 46.28
83. LEBANON 1,207.23 3,275.83 171.35 22.55 112.69 399.79
84. CHAD 2,265.74 3,254.05 43.62 153.97 180.82 17.44
85. BURUNDI 2,489.06 3,137.37 26.05 131.76 207.67 57.62
86. ITALY 3,861.46 3,080.80 -20.22 156.97 153.54 -2.19
87. SYRIA 1,989.47 2,985.12 50.05 56.29 1,311.6 2,230.15
6
88. CUBA 1,421.71 2,971.76 109.03 70.01 88.01 25.72
89. TURKEY 2,353.69 2,951.16 25.38 118.07 93.07 -21.17
90. KOREA RP 1,685.57 2,879.49 70.83 86.07 37.00 -57.01
91. CROATIA 2,926.87 2,866.50 -2.06 36.35 56.72 56.00
92. LIBYA 3,210.74 2,838.07 -11.61 293.09 241.72 -17.53
93. PAKISTAN IR 1,364.86 2,736.90 100.53 100.56 259.15 157.72
94. HAITI 3,327.33 2,729.73 -17.96 264.45 203.85 -22.92
95. MALDIVES 2,272.90 2,676.02 17.74 229.27 142.29 -37.94
96. PAPUA N GNA 1,699.71 2,655.24 56.22 507.83 271.15 -46.60
97. SWEDEN 1,909.81 2,643.73 38.43 84.61 162.15 91.66
98. TRINIDAD 2,049.75 2,581.34 25.93 133.08 107.03 -19.58
99. COSTA RICA 2,282.97 2,532.01 10.91 101.12 114.65 13.39
100 CZECH 3,572.13 2,511.72 -29.69 69.92 102.86 47.12
. REPUBLIC
101 MALI 2,823.88 2,481.35 -12.13 274.63 245.32 -10.67
.
102 SENEGAL 1,278.75 2,443.26 91.07 109.32 164.20 50.20
.
103 SOMALIA 1,219.63 2,442.00 100.23 412.96 424.46 2.79
.
104 LITHUANIA 1,332.39 2,418.36 81.50 49.66 76.08 53.18
.
105 ECUADOR 2,389.88 2,414.93 1.05 31.49 53.76 70.75
.
106 GUATEMALA 2,045.46 2,400.80 17.37 120.07 197.60 64.58
.
107 BELARUS 1,800.56 2,375.29 31.92 51.42 69.21 34.62
.
108 COTE D' IVOIRE 1,950.37 2,219.84 13.82 176.80 104.33 -40.99
.
109 PANAMA 2,338.05 2,122.79 -9.21 71.16 77.59 9.04
. REPUBLIC
110 BULGARIA 1,573.47 2,066.15 31.31 50.13 75.87 51.34
.
111 SIERRA LEONE 1,671.71 1,898.23 13.55 635.47 251.41 -60.44
.
112 MADAGASCAR 2,091.06 1,890.17 -9.61 296.13 186.50 -37.02
.
113 LATVIA 986.52 1,874.87 90.05 123.82 147.18 18.87
.
114 GUYANA 1,514.10 1,855.33 22.54 110.13 161.21 46.39
.
115 EL SALVADOR 1,734.62 1,836.62 5.88 115.64 152.59 31.96
.
116 ERITREA 996.78 1,813.21 81.91 78.97 94.44 19.59
.
117 GEORGIA 1,602.58 1,798.71 12.24 165.77 121.86 -26.49
.
118 AUSTRIA 2,747.78 1,771.75 -35.52 38.53 42.64 10.67
.
119 BOLIVIA 2,141.28 1,738.85 -18.79 243.16 98.77 -59.38
.
120 LIBERIA 1,622.98 1,606.53 -1.01 431.41 152.57 -64.63
.
121 GABON 1,308.66 1,569.82 19.96 46.05 32.20 -30.08
.
122 KYRGHYZSTAN 914.45 1,453.84 58.99 157.90 117.46 -25.61
.
123 OMAN 1,050.40 1,391.37 32.46 35.84 47.68 33.02
.
124 TAIWAN 758.20 1,250.84 64.98 13.65 19.49 42.73
.
125 NICARAGUA 1,540.09 1,205.88 -21.70 208.28 155.84 -25.18
.
126 C AFRI REP 1,419.97 1,146.73 -19.24 29.29 74.92 155.75
.
127 EGYPT A RP 1,173.87 1,127.16 -3.98 66.10 45.65 -30.93
.
128 CHINA P RP 747.07 1,126.88 50.84 18.09 51.68 185.69
.
129 SERBIA 1,124.10 8.47
.
130 MAURITANIA 419.18 1,027.62 145.15 58.64 131.51 124.27
.
131 UNION OF 1,483.07 1,026.94 -30.76 45.60 58.18 27.58
. SERBIA &
MONTENEGRO
132 MOLDOVA 967.09 956.49 -1.10 45.38 46.49 2.44
.
133 GAMBIA 554.55 953.30 71.91 81.77 74.10 -9.38
.
134 URUGUAY 1,361.38 952.69 -30.02 14.94 12.26 -17.96
.
135 VANUATU REP 1,062.00 952.37 -10.32 9.64 11.16 15.83
.
136 HONDURAS 2,773.69 827.07 -70.18 107.77 87.31 -18.99
.
137 ARGENTINA 651.59 820.23 25.88 5.60 11.44 104.16
.
138 AZERBAIJAN 1,451.50 791.54 -45.47 101.40 69.30 -31.66
.
139 SEYCHELLES 549.40 790.03 43.80 19.28 41.03 112.84
.
140 SAUDI ARAB 549.71 730.05 32.81 41.23 74.25 80.09
.
141 FIJI IS 702.67 633.50 -9.84 108.39 38.99 -64.03
.
142 CYPRUS 683.98 613.09 -10.36 12.05 17.41 44.44
.
143 BANGLADESH 804.09 592.66 -26.30 21.23 21.40 0.80
. PR
144 PARAGUAY 729.76 584.87 -19.85 20.48 10.71 -47.69
.
145 KOREA DP RP 521.52 478.88 -8.18 36.74 35.85 -2.41
.
146 SLOVAK REP 1,753.16 471.52 -73.10 24.36 9.35 -61.62
.
147 GUINEA BISSAU 263.05 441.41 67.80 19.11 36.00 88.35
.
148 BAHAMAS 466.69 412.48 -11.62 14.67 10.15 -30.80
.
149 BHUTAN 397.77 384.62 -3.31 35.51 108.86 206.54
.
150 NETHERLANDAN 632.14 368.88 -41.65 45.51 21.41 -52.95
. TIL
151 MONGOLIA 223.26 351.14 57.28 16.39 29.20 78.22
.
152 BAHARAIN IS 427.79 347.19 -18.84 8.98 5.73 -36.21
.
153 SURINAME 155.89 344.39 120.92 8.37 7.94 -5.15
.
154 LAO PD RP 160.52 314.96 96.21 9.63 10.87 12.89
.
155 BOSNIA- 256.97 302.82 17.84 9.72 12.46 28.16
. HRZGOVIN
156 MACEDONIA 288.32 302.51 4.92 4.23 4.11 -2.77
.
157 EQUTL GUINEA 441.60 295.74 -33.03 57.52 31.80 -44.73
.
158 KUWAIT 122.60 287.74 134.69 9.81 19.78 101.72
.
159 ISRAEL 208.76 279.19 33.74 7.45 21.08 182.81
.
160 DJIBOUTI 192.69 271.73 41.02 39.83 8.04 -79.81
.
161 ARMENIA 123.86 234.24 89.11 11.06 12.82 15.99
.
162 GREECE 822.45 216.21 -73.71 39.71 6.05 -84.76
.
163 ST LUCIA 97.19 188.31 93.75 5.26 11.35 115.78
.
164 BARBADOS 616.58 131.34 -78.70 20.61 5.82 -71.75
.
165 MICRONESIA 90.81 101.34 11.60 1.88 3.67 95.37
.
166 BELIZE 141.73 97.32 -31.34 7.51 2.83 -62.26
.
167 FR GUIANA 85.08 1.30
.
168 QATAR 164.49 85.06 -48.29 14.84 8.58 -42.23
.
169 TONGA 19.55 80.00 309.30 0.19 12.42 6,576.34
.
170 SOLOMON IS 53.16 71.91 35.29 7.39 2.09 -71.66
.
171 COMOROS 13.72 70.17 411.31 1.30 36.06 2,682.41
.
172 ANTIGUA 52.77 65.67 24.45 1.30 1.34 2.85
.
173 CAYMAN IS 19.26 63.95 232.07 0.37 2.28 521.58
.
174 SAMOA 39.63 57.12 44.15 0.99 10.35 943.85
.
175 ESTONIA 184.33 51.87 -71.86 5.84 5.30 -9.20
.
176 MACAO 73.51 51.76 -29.59 3.22 1.25 -61.20
.
177 CAPE VERDE IS 29.07 48.20 65.83 0.39 1.13 190.75
.
178 ST KITT N A 38.86 43.06 10.80 0.95 2.03 114.24
.
179 TUNISIA 204.06 34.09 -83.29 1.89 0.79 -58.28
.
180 ST VINCENT 39.96 33.06 -17.28 0.83 0.78 -6.83
.
181 NORWAY 67.76 31.29 -53.82 10.77 1.05 -90.22
.
182 GRENADA 22.56 26.43 17.16 0.88 0.99 12.12
.
183 SAO TOME 14.62 26.07 78.27 0.23 0.76 234.21
.
184 MONTENEGRO 25.56 0.33
.
185 DOMINICA 326.29 23.11 -92.92 10.05 1.06 -89.45
.
186 ALBANIA 57.26 18.76 -67.23 1.77 0.48 -72.82
.
187 LUXEMBOURG 16.91 18.51 9.50 0.09 0.16 75.56
.
188 TIMOR LESTE 311.06 17.46 -94.39 14.21 2.18 -84.65
.
189 BR VIRGN IS 0.08 13.66 17,168.1 0.02 0.16 695.00
. 4
190 PALAU 16.00 12.14 -24.09 0.14 0.11 -18.84
.
191 KIRIBATI REP 3.50 11.70 234.44 0.90 0.68 -25.00
.
192 MARSHALL 12.87 7.93 -38.35 0.33 0.25 -23.31
. ISLAND
193 ICELAND 35.73 4.61 -87.09 0.55 0.32 -42.55
.
194 PUERTO RICO 0.42 4.38 954.08 0.02 0.25 1,150.00
.
195 BRUNEI 2.30 0.06
.
196 GUAM 103.37 2.02 -98.05 3.32 0.38 -88.57
.
197 MONTSERRAT 0.64 1.84 188.79 0.00 0.05 1,700.00
.
198 NAURU RP 1.76 0.03
.
199 ANGUILLA 1.03 1.70 64.98 0.03 0.03 -12.12
.
200 GIBRALTAR 1.67 0.04
.
201 TUVALU 0.44 0.03
.
202 REUNION 0.09 0.02
.
203 PANAMA C Z 0.02 0.00
.
2,086,427. 2,560,318.
Total 22.71
98 81

N.E.S Unit: KGS
2012- 2013-
2012-2013 2013-2014 %Growth %Growth
2013 2014
1. SWITZERLAND 42,316.70 43,137.38 1.94 43.75 57.57 31.61
2. GERMANY 26,205.81 35,640.97 36.00 21.43 97.39 354.53
3. U S A 29,105.65 32,629.05 12.11 27.80 45.67 64.27
4. ITALY 25,638.39 23,354.98 -8.91 18.00 38.91 116.19
5. U K 18,735.12 21,618.33 15.39 16.37 39.12 139.00
6. FRANCE 18,984.63 15,853.37 -16.49 18.72 24.01 28.28
7. NETHERLAND 8,196.64 10,341.38 26.17 6.83 13.94 104.07
8. BELGIUM 5,680.04 6,602.63 16.24 9.81 8.71 -11.16
9. IRELAND 8,403.77 5,705.67 -32.11 5.06 7.09 39.93
10. CANADA 2,243.56 5,163.37 130.14 2.94 12.28 317.87
11. FINLAND 2,101.45 5,086.05 142.03 1.95 20.69 963.80
12. CHINA P RP 3,585.55 4,574.38 27.58 6.53 25.94 297.15
13. SWEDEN 3,824.99 4,515.30 18.05 5.26 21.88 315.74
14. DENMARK 4,560.32 4,265.60 -6.46 4.06 4.14 1.87
15. PUERTO RICO 2,065.22 3,915.67 89.60 1.33 7.16 439.59
16. MEXICO 2,126.68 2,740.39 28.86 2.58 2.90 12.57
17. JAPAN 5,269.03 2,334.33 -55.70 5.24 2.68 -48.92
18. SPAIN 1,775.61 1,589.65 -10.47 2.91 2.99 2.92
19. AUSTRALIA 888.58 1,549.93 74.43 1.64 2.13 30.24
20. AUSTRIA 2,214.01 1,486.62 -32.85 2.61 1.65 -36.75
21. SINGAPORE 1,025.68 1,312.70 27.98 1.16 2.64 126.44
22. SOUTH AFRICA 791.27 947.76 19.78 4.91 0.80 -83.75
23. KOREA RP 989.10 785.44 -20.59 0.91 0.88 -3.07
24. MALAYSIA 2,076.59 720.81 -65.29 2.13 18.88 785.19
25. HUNGARY 126.44 634.29 401.63 0.61 0.84 39.50
26. TAIWAN 75.77 521.65 588.45 0.07 0.74 909.59
27. BRAZIL 454.66 457.00 0.52 0.49 0.36 -26.83
28. MALTA 319.27 432.33 35.41 0.58 0.32 -45.42
29. UNSPECIFIED 96.37 270.73 180.91 0.40 0.20 -49.88
30. CZECH 129.80 194.77 50.05 1.22 11.37 833.58
REPUBLIC
31. ISRAEL 405.25 188.96 -53.37 0.87 1.07 22.08
32. URUGUAY 114.54 0.11
33. TURKEY 192.09 108.00 -43.78 0.08 0.32 289.02
34. RUSSIA 3.86 95.18 2,363.20 0.00 0.08 1,400.00
35. POLAND 176.58 39.89 -77.41 0.16 0.08 -47.77
36. ARGENTINA 30.30 36.34 19.91 0.03 0.01 -75.86
37. SLOVAK REP 26.31 0.03
38. PHILIPPINES 39.95 21.95 -45.07 0.07 0.02 -72.60
39. BULGARIA 4.33 21.93 406.41 0.00 0.02 375.00
40. PORTUGAL 29.63 20.98 -29.18 0.04 0.02 -46.34
41. HONG KONG 114.69 18.48 -83.89 0.11 0.01 -90.83
42. THAILAND 6.72 14.58 116.99 0.01 0.01 0.00
43. CYPRUS 3.83 12.47 225.47 0.00 0.02 325.00
44. LITHUANIA 11.05 0.01
45. U ARAB EMTS 10.46 10.21 -2.40 0.00 0.01 20.00
46. NEW ZEALAND 7.69 6.60 -14.24 0.01 0.01 100.00
47. MALDIVES 6.03 0.01
48. CHILE 63.37 5.01 -92.09 1.04 0.00 -99.52
49. LIBERIA 4.84 0.00
50. GREECE 7.85 2.38 -69.73 0.01 0.01 -46.15
52. ICELAND 15.80 1.84 -88.37 0.01 0.00 -70.00
53. SLOVENIA 21.89 1.82 -91.70 0.09 0.00 -97.73
54. AFGHANISTAN 1.37 0.01
TIS
55. INDONESIA 0.99 1.00 1.22 0.00 0.00 0.00
56. LATVIA 6.21 0.97 -84.42 0.01 0.00 -87.50
57. ROMANIA 11.08 0.79 -92.84 0.01 0.01 -53.85
58. MOROCCO 0.10 0.62 546.69 0.00 0.01 175.00
59. GEORGIA 0.42 0.00
60. KENYA 0.38 0.14 -62.49 0.00
61. CROATIA 0.05 0.02 -58.08
62. COSTA RICA 0.02
63. ALGERIA 0.54 0.00
64. BANGLADESH 0.04
PR
65. GABON 0.30
66. JORDAN 0.09
67. JAMAICA 0.69
68. KOREA DP RP 6.35 0.00
69. NAMIBIA 0.51
71. PERU 42.03 0.04
72. SAUDI ARAB 1.18 0.01
74. SWAZILAND 57.13 0.04
75. VENEZUELA 3.37
76. ZAMBIA 1.61 0.00
77. UKRAINE 0.16
Total 221,274.41 239,159.18 8.08

Countries: USA, South Africa, Russia, Kenya, UK, Nigeria, Zambia, Tanzania,
Uganda, Ghana, Canada, Sri Lanka, Germany, Ethiopia, Vietnam
Region: N. America, Africa, Russia, Europe
11. PROTISURE POW MANGO / PROTISURE POW CHOCO
Indications: Protein supplement during pregnancy and for child
HS Code: 21061000
21061000  Soups and broths and preparations therefor: Protein concentrates and
textured protein substances

Duty Drawback: - 1%
Commodity: 21061000 PROTEIN CONCNTRTS AND TEXTURED PROTN SBSTNCS Unit: KGS

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. SAUDI ARABIA 2,110.17 2,687.23 27.35 3,440.39 4,724.82 37.33
2. PHILIPPINES 1,435.05 1,844.45 28.53 2,592.65 3,052.42 17.73
3. UNSPECIFIED 1,666.98 513.48
4. KOREA RP 889.01 1,648.03 85.38 1,685.17 2,742.20 62.73
5. U ARAB EMTS 626.52 1,058.27 68.91 1,028.03 1,592.47 54.90
6. INDONESIA 519.89 845.41 62.61 961.72 1,347.90 40.16
7. NETHERLAND 545.67 573.10 5.03 449.95 969.33 115.43
8. TURKEY 703.77 554.20 -21.25 1,421.15 981.57 -30.93
9. VIETNAM SOC REP 291.28 514.28 76.56 538.96 760.20 41.05
10. JORDAN 236.24 425.89 80.28 461.14 704.90 52.86
11. MALAYSIA 193.48 370.03 91.25 228.99 565.78 147.08
12. TAIWAN 217.47 365.75 68.18 416.59 654.90 57.21
13. NEPAL 240.21 315.11 31.18 227.52 329.11 44.65
14. NEW ZEALAND 284.26 294.11 3.46 547.73 488.20 -10.87
15. KUWAIT 123.87 252.07 103.49 228.71 434.80 90.11
16. JAPAN 145.79 244.11 67.45 69.88 121.26 73.53
17. AUSTRALIA 136.97 213.16 55.63 227.17 322.87 42.13
18. SOUTH AFRICA 171.94 203.52 18.37 302.33 318.67 5.40
19. QATAR 134.29 122.70 -8.63 136.45 176.10 29.06
20. YEMEN REPUBLC 72.25 102.04 41.25 129.68 189.00 45.74
21. OMAN 11.04 98.98 796.49 22.11 172.66 680.91
22. EGYPT A RP 6.73 98.84 1,368.97 10.00 175.00 1,650.00
23. IRAN 50.70 95.60 88.58 96.00 137.00 42.71
24. ARGENTINA 41.98 71.05 69.25 20.00 30.00 50.00
25. SPAIN 159.72 68.56 -57.07 186.02 136.25 -26.76
26. MAURITIUS 22.08 45.74 107.13 37.22 61.83 66.10
27. PERU 27.84 45.69 64.14 38.00 76.00 100.00
28. ISRAEL 4.87 45.33 829.94 9.00 75.00 733.33
29. SUDAN 45.31 79.00
30. IRAQ 43.27 80.00
31. NIGERIA 0.77 43.02 5,484.24 1.40 34.39 2,356.57
32. PAKISTAN IR 28.30 41.18 45.53 53.50 54.00 0.94
33. FRANCE 15.52 40.65 161.83 6.79 14.59 114.71
34. GHANA 35.32 48.20
35. CHINA P RP 29.76 14.00
36. CANADA 36.45 27.32 -25.06 42.48 26.72 -37.10
37. U K 64.43 26.42 -59.00 131.22 36.25 -72.37
38. SRI LANKA DSR 63.23 24.47 -61.30 38.58 12.12 -68.60
39. KOREA DP RP 23.82 9.50
40. BANGLADESH PR 1.93 22.93 1,089.38 0.60 12.08 1,913.33
41. THAILAND 16.22 24.00
42. LEBANON 13.68 7.00
43. BAHARAIN IS 16.92 11.30 -33.21 21.30 8.25 -61.27
44. SINGAPORE 8.04 9.25 14.98 16.48 3.50 -78.77
45. BHUTAN 34.16 7.68 -77.52 16.00 12.00 -25.00
46. MALTA 7.46 12.00
47. FIJI IS 6.10 4.00
48. GERMANY 44.34 5.28 -88.10 65.17 5.43 -91.67
49. U S A 292.50 4.97 -98.30 92.97 1.56 -98.32
50. ITALY 0.45 3.95 784.59 0.02 6.60 32,900.00
51. GEORGIA 3.71 9.00
52. MYANMAR 3.03 1.20
53. GUINEA 1.32 2.18
54. GREECE 0.89 0.53
55. KENYA 1.91 0.77 -59.90 0.66 0.80 20.85
56. URUGUAY 0.71 1.02
57. CONGO P REP 0.50 0.43
58. RWANDA 0.21 0.46 115.58 0.06 0.20 212.50
59. HONG KONG 0.97 0.44 -54.65 1.30 0.29 -77.62
60. NETHERLANDANTIL 0.03 0.28 871.78 0.03 0.21 603.33
61. BELGIUM 5.97 0.26 -95.68 8.64 0.24 -97.21
62. MOZAMBIQUE 11.67 0.22 -98.09 19.77 0.10 -99.49
63. MALDIVES 3.88 0.16 -95.76 2.78 0.20 -92.82
64. CONGO D. REP. 0.03 0.02
65. ZAMBIA 0.28 0.14
66. UKRAINE 36.56 30.00
67. UGANDA 0.53 0.20
69. SWEDEN 3.06 8.45
71. CHAD 0.02 0.00
72. CHILE 21.73 41.99
74. IRELAND 28.52 44.00
75. LIBERIA 0.16 0.23
76. LITHUANIA 2.50 0.62
Total 10,135.93 15,372.39 51.66

Approximate amount of Import Countrywise to India
Commodity: 21061000 PROTEIN CONCNTRTS AND TEXTURED PROTN SBSTNCS Unit: KGS

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. USA 7,489.46 8,087.65 7.99 1,466.73 1,591.70 8.52
2. GERMANY 310.34 391.02 26.00 81.83 87.52 6.95
3. THAILAND 96.88 331.34 242.01 47.05 263.79 460.68
4. CHINA P RP 173.23 282.53 63.09 54.35 65.30 20.16
5. U ARAB EMTS 338.33 227.58 -32.73 147.27 59.28 -59.75
6. DENMARK 6.77 221.23 3,169.05 5.03 51.40 921.95
7. MALAYSIA 152.94 167.09 9.25 12.19 9.38 -23.03
8. FRANCE 9.61 142.09 1,378.19 4.16 12.89 209.93
9. NETHERLAND 190.43 124.70 -34.52 54.59 18.54 -66.03
10. U K 74.43 105.51 41.76 14.23 13.41 -5.72
11. CANADA 185.78 94.56 -49.10 42.70 27.19 -36.32
12. HUNGARY 108.49 84.08 -22.50 11.69 10.51 -10.09
13. SAUDI ARAB 0.57 64.19 11,106.22 0.02 52.10 325,524.97
14. TURKEY 15.81 24.00
15. SINGAPORE 46.95 11.93 -74.58 20.33 1.51 -92.56
16. ISRAEL 145.06 9.45 -93.49 1.82 4.50 147.25
17. JAPAN 3.48 8.52 144.96 0.40 3.15 692.21
18. BRAZIL 0.23 8.42 3,600.18 0.01 5.04 50,300.00
19. SWITZERLAND 15.79 7.38 -53.25 1.83 0.70 -61.64
20. BAHARAIN IS 5.73 14.18
21. POLAND 124.99 2.87 -97.70 33.82 1.10 -96.75
22. SPAIN 9.70 0.96 -90.13 7.05 0.32 -95.50
23. ITALY 0.15 0.69 350.10 0.03 0.43 1,228.12
24. BELGIUM 7.24 0.55 -92.36 1.30 0.04 -97.23
25. MEXICO 0.34 0.05
26. SOUTH AFRICA 0.31 0.11
27. NEW ZEALAND 12.36 2.70
28. PERU 3.15 0.35
29. KOREA RP 2.11 0.46
30. TAIWAN 5.95 1.15
31. CZECH REPUBLIC 4.41 0.83
Total 9,518.83 10,396.53 9.22
Countries: Saudi Arabia, Philippines, Korea, UAE, Indonesia, Netherlands, Turkey,

Vietnam, Jordan, Malaysia, Taiwan, Nepal, New Zealand, Kuwait
Region: Middle East, Far East. Asia, Europe, New Zealand
12. RABECORE DSR
Contents: RABEPRAZOLE 20 MG + DOMPERIDONE 30 MG SR CAP
Indications: Antacid, in treatment of gerd, nausea vomiting, Protein pump inhibitor (PPI)
Branches: GP, Gynecology, Orthopedic, Neurology

HS Code: 30049039

Duty Drawback: - -

300490  Other
30049039  Antihistaminics drugs; Antacids preparations; Antiulcer drugs; Antiemitics

and other Gastro intestinal drugs: Other
Commodity: 30049039 OTHER ANTINISTANINICS ,ANTACIDS,ANTIULCER,ANTIEMITICS AND

OTHER GASTOINTESTINAL DRUGS Unit: KGS
2012- 2013- 2012- 2013-
%Growth %Growth
2013 2014 2013 2014
1. USA 18,782.92 37,274.26 98.45 797.75 1,218.88 52.79
2. GERMANY 7,230.88 7,035.41 -2.70 693.95 1,049.21 51.19
3. SOUTH AFRICA 5,024.81 5,709.97 13.64 264.95 215.59 -18.63
4. NIGERIA 3,112.40 5,300.06 70.29 490.15 709.18 44.68
5. BRAZIL 2,304.72 4,521.57 96.19 93.53 127.75 36.58
6. UK 6,904.47 4,512.69 -34.64 846.29 293.41 -65.33
7. UNSPECIFIED 564.25 4,353.13 671.48 13.46 8.90 -33.85
8. VENEZUELA 1,999.06 4,107.90 105.49 19.08 20.04 5.04
9. MYANMAR 1,874.23 3,508.96 87.22 231.35 393.21 69.96
10. BELGIUM 4,990.65 3,453.89 -30.79 109.19 241.79 121.44
11. SRI LANKA DSR 2,409.80 3,398.22 41.02 212.60 311.33 46.44
12. IRELAND 2,380.91 3,198.24 34.33 179.10 275.38 53.76
13. AUSTRALIA 3,261.85 3,005.77 -7.85 103.06 76.15 -26.11
14. FRANCE 3,549.59 2,809.75 -20.84 154.51 153.76 -0.48
15. RUSSIA 2,803.77 2,804.37 0.02 57.49 62.85 9.32
16. VIETNAM SOC REP 2,651.71 2,725.11 2.77 170.05 160.23 -5.78
17. GHANA 1,878.63 2,578.56 37.26 394.47 469.82 19.10
18. LIBYA 1,286.67 2,413.21 87.56 129.10 216.03 67.33
19. INDONESIA 609.41 1,951.96 220.30 23.23 37.01 59.28
20. NETHERLAND 1,016.00 1,819.67 79.10 58.15 87.96 51.28
21. MAURITIUS 2,531.32 1,746.03 -31.02 33.39 27.92 -16.38
22. AFGHANISTAN TIS 740.34 1,364.84 84.35 130.12 212.97 63.67
23. SUDAN 457.97 1,041.16 127.34 29.92 36.52 22.05
24. CANADA 927.90 980.81 5.70 23.72 28.93 21.99
25. PERU 393.75 968.09 145.86 27.14 63.47 133.90
26. SPAIN 1,177.93 946.49 -19.65 144.65 181.64 25.57
27. HAITI 566.06 900.51 59.08 139.41 133.82 -4.01
28. UKRAINE 652.08 837.32 28.41 17.07 8.41 -50.76
29. TAIWAN 180.37 741.16 310.91 5.37 23.89 345.17
30. COSTA RICA 554.65 698.58 25.95 24.87 26.53 6.67
31. BENIN 284.64 668.91 135.00 37.70 112.28 197.78
32. MALAYSIA 499.18 647.66 29.75 30.22 22.94 -24.11
33. EGYPT A RP 1,107.79 640.80 -42.16 76.50 55.30 -27.71
34. KENYA 7,539.44 629.72 -91.65 99.25 45.66 -53.99
35. ECUADOR 9.04 613.31 6,681.18 0.10 5.60 5,729.17
36. MEXICO 70.48 564.09 700.41 3.69 28.57 673.10
37. NEPAL 113.55 536.16 372.16 25.20 41.21 63.49
38. BURKINA FASO 53.35 506.69 849.72 11.52 41.22 257.75
39. SINGAPORE 677.56 484.98 -28.42 37.51 15.93 -57.55
40. CAMBODIA 472.53 443.62 -6.12 62.67 56.72 -9.49
41. ROMANIA 376.13 417.04 10.87 12.68 6.57 -48.20
42. YEMEN REPUBLC 220.89 406.67 84.11 30.46 48.09 57.87
43. TANZANIA REP 385.98 405.35 5.02 44.97 33.04 -26.51
44. UZBEKISTAN 363.29 400.34 10.20 48.12 35.55 -26.12
45. ALGERIA 44.87 395.99 782.50 2.09 7.56 261.58
46. PHILIPPINES 359.86 385.91 7.24 34.80 20.93 -39.85
47. KAZAKHSTAN 851.76 359.26 -57.82 33.79 6.58 -80.54
48. NEW ZEALAND 624.82 351.82 -43.69 32.88 15.93 -51.56
49. ETHIOPIA 197.63 348.04 76.10 19.59 26.45 35.05
50. CROATIA 325.66 347.94 6.84 4.65 5.71 22.87
51. DENMARK 13.91 332.34 2,289.81 0.89 22.41 2,415.38
52. MOROCCO 140.13 332.10 137.00 1.90 2.42 27.53
53. SIERRA LEONE 285.13 289.67 1.59 44.37 61.07 37.64
54. IRAN 523.75 277.41 -47.03 12.77 15.26 19.55
55. THAILAND 162.21 267.43 64.86 18.71 42.03 124.64
56. CHINA P RP 21.22 266.73 1,156.90 0.40 5.16 1,189.50
57. HONG KONG 243.76 242.73 -0.42 15.43 14.74 -4.46
58. PANAMA REPUBLIC 177.66 241.77 36.09 15.25 13.53 -11.30
59. KOREA DP RP 15.54 231.92 1,392.84 0.04 98.19 228,251.16
60. HONDURAS 173.22 229.31 32.38 25.39 22.94 -9.63
61. GEORGIA 131.80 216.40 64.20 6.36 14.10 121.81
62. JORDAN 38.22 211.40 453.15 11.19 5.16 -53.88
63. JAMAICA 69.61 202.52 190.92 5.28 7.45 41.25
64. U ARAB EMTS 96.93 187.60 93.55 3.75 3.54 -5.44
65. JAPAN 203.11 186.60 -8.13 34.35 44.43 29.33
66. ANGOLA 234.28 184.25 -21.36 33.57 12.41 -63.05
67. UGANDA 115.80 184.09 58.97 18.47 22.50 21.83
68. MALI 138.62 177.17 27.81 20.66 23.82 15.28
69. ZIMBABWE 58.79 175.57 198.67 4.35 6.06 39.23
70. AUSTRIA 174.69 2.19
71. PORTUGAL 165.80 159.60 -3.74 4.18 7.93 89.73
72. MAURITANIA 2.20 149.33 6,677.54 0.37 26.70 7,059.52
73. CHILE 224.20 148.39 -33.81 21.44 7.35 -65.71
74. GAMBIA 113.74 145.33 27.77 13.44 9.34 -30.50
75. ITALY 200.32 141.42 -29.40 6.90 8.19 18.73
76. TRINIDAD 46.90 134.82 187.44 5.08 10.25 101.99
77. BELARUS 96.17 133.15 38.45 13.02 5.35 -58.92
78. BAHARAIN IS 31.08 132.24 325.51 0.70 1.05 50.21
79. MALDIVES 151.47 117.89 -22.17 15.73 11.79 -25.00
80. GUINEA 91.68 116.94 27.56 18.05 10.05 -44.29
81. IRAQ 65.86 105.81 60.65 5.21 4.36 -16.25
82. CONGO D. REP. 40.39 102.40 153.53 19.59 12.81 -34.62
83. ZAMBIA 509.76 96.88 -81.00 37.23 14.97 -59.79
84. FINLAND 57.07 93.30 63.48 1.27 2.47 95.04
85. PAPUA N GNA 3.35 84.93 2,436.25 0.64 4.49 601.56
86. CAMEROON 20.75 83.38 301.82 3.28 13.56 313.67
87. GUATEMALA 57.01 83.09 45.74 5.11 2.89 -43.39
88. CONGO P REP 89.80 80.01 -10.90 18.68 8.88 -52.46
89. MALTA 25.86 74.22 186.97 1.40 4.66 232.57
90. LITHUANIA 25.63 59.27 131.25 3.83 3.51 -8.25
91. COLOMBIA 116.81 58.85 -49.62 5.20 21.24 308.70
92. KYRGHYZSTAN 22.45 54.42 142.39 3.56 8.47 137.70
93. MOLDOVA 22.42 51.72 130.65 4.06 1.99 -51.01
94. AZERBAIJAN 29.86 49.91 67.13 4.94 5.65 14.37
95. NETHERLANDANTIL 0.19 47.64 24,686.63 0.02 3.34 18,427.78
96. DOMINIC REP 142.77 47.42 -66.79 28.64 3.86 -86.53
97. TAJIKISTAN 74.69 45.34 -39.29 28.71 11.45 -60.10
98. OMAN 5.25 44.25 743.07 0.78 2.33 196.68
99. HUNGARY 134.99 43.72 -67.62 17.61 2.63 -85.07
100. MOZAMBIQUE 157.60 42.33 -73.14 40.38 2.50 -93.81
101. BANGLADESH PR 41.40 40.18 -2.95 7.31 6.13 -16.16
102. LIBERIA 105.90 37.69 -64.41 15.63 26.11 67.09
103. SOMALIA 47.46 35.42 -25.38 11.35 3.59 -68.41
104. TOGO 426.10 33.21 -92.21 37.19 0.80 -97.84
105. BOTSWANA 7.81 30.16 285.97 0.35 0.76 116.19
106. MADAGASCAR 82.59 29.51 -64.27 20.96 3.87 -81.56
107. LEBANON 101.90 25.60 -74.88 9.34 1.80 -80.74
108. TURKEY 121.46 22.88 -81.16 2.47 1.58 -35.90
109. ARMENIA 31.09 22.14 -28.80 3.80 0.75 -80.26
110. RWANDA 22.15 20.69 -6.58 2.65 1.64 -38.02
111. MALAWI 31.98 19.37 -39.43 7.47 1.49 -80.06
112. SENEGAL 19.10 1.21
113. EL SALVADOR 1.11 17.93 1,512.55 0.10 1.00 900.00
114. FIJI IS 30.80 17.89 -41.91 1.99 1.45 -27.37
115. GUYANA 17.40 2.37
116. TURKMENISTAN 146.92 15.81 -89.24 19.02 2.21 -88.38
117. CZECH REPUBLIC 15.55 0.46
118. PAKISTAN IR 19.01 14.75 -22.37 3.46 4.07 17.84
119. BOLIVIA 47.94 13.92 -70.95 1.56 0.57 -63.39
120. BAHAMAS 9.21 11.50 24.89 0.64 0.50 -21.56
121. KOREA RP 296.80 10.85 -96.35 64.64 1.51 -97.66
122. KUWAIT 3.96 10.80 172.90 0.79 0.54 -30.88
123. NAMIBIA 25.28 10.75 -57.49 0.42 0.37 -12.26
124. PARAGUAY 5.89 9.53 61.89 0.25 1.60 529.92
125. LESOTHO 3.13 8.77 179.95 0.90 0.63 -30.56
126. LAO PD RP 3.02 8.53 182.70 0.41 0.32 -21.18
127. LATVIA 87.79 8.45 -90.37 12.21 0.35 -97.16
128. GABON 7.73 4.18
129. POLAND 18.00 7.30 -59.47 1.00 0.45 -55.30
130. MONGOLIA 19.24 6.40 -66.75 1.98 0.50 -74.68
131. CUBA 5.95 0.15
132. NICARAGUA 19.46 5.66 -70.92 1.44 0.70 -51.49
133. DOMINICA 5.50 0.09
134. VANUATU REP 11.16 4.41 -60.47 0.16 0.09 -43.75
135. SWEDEN 12.11 3.21 -73.51 0.29 0.05 -82.41
136. SAMOA 2.58 0.09
137. BURUNDI 44.58 2.25 -94.96 16.08 0.40 -97.51
138. CHAD 98.22 1.00 -98.98 10.20 0.10 -99.02
139. BELIZE 0.43 0.01
140. BARBADOS 15.97 0.23 -98.56 2.20 0.05 -97.95
141. ST KITT N A 2.67 0.09 -96.51 0.09 0.01 -86.05
142. ANTIGUA 0.07 0.01
143. NIGER 74.50 0.03 -99.96 5.58 0.02 -99.62
144. GRENADA 0.03 0.00
145. ANGUILLA 0.01 0.00
146. ARGENTINA 0.07 0.00
147. BOSNIA-HRZGOVIN 1.47 0.02
148. COTE D' IVOIRE 1.89 0.16
149. PUERTO RICO 1.21 0.10
150. MONACO 19.02 1.50
151. MACEDONIA 8.45 0.45
152. ST VINCENT 0.17 0.01
153. SURINAME 3.98 0.20
154. UNION OF SERBIA & 36.62 1.68
MONTENEGRO
156. SOLOMON IS 2.74 0.30
Total 105,067.77 134,182.91 27.71
Commodity: 30049039 OTHER ANTINISTANINICS ,ANTACIDS,ANTIULCER,ANTIEMITICS AND

OTHER GASTOINTESTINAL DRUGS Unit: KGS
2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. GERMANY 600.23 666.96 11.12 0.36 2.10 483.06
2. UK 560.43 0.20
3. ITALY 199.41 236.49 18.60 0.09 0.10 5.26
4. SWITZERLAND 370.18 208.09 -43.79 0.10 0.14 36.00
5. MALAYSIA 194.26 192.88 -0.71 0.15 0.08 -45.95
6. USA 150.07 87.35 -41.80 0.07 0.08 18.84
7. SOUTH AFRICA 7.83 55.07 602.86 0.01 0.99 10,900.00
8. FRANCE 41.01 0.04
9. BRAZIL 3.31 0.00
10. MEXICO 0.80 1.00 26.30 0.00
11. CANADA 2.79 0.49 -82.30 0.00
12. IRELAND 0.07 0.17 147.43 0.00
13. VENEZUELA 0.08
Total 1,542.08 2,053.33 33.15
Company: USA, Germany, South Africa, Nigeria, Brazil, UK, Venezuela, Myanmar,
Belgium, Sri Lanka, Ireland, Australia, France, Russia
Region: USA, Europe, Africa, Neighboring countries Europe, CIS, Australia
13. Cyclo Sure:
Basic: Norethisterone (or norethindrone) (or 19-nor-17α-ethynyltestosterone) is a

molecule used in some combined oral contraceptive pills, progestogen only pills and is
also available as a stand-alone drug. It is a progestogen and can be used to treat
premenstrual syndrome, painful periods, abnormal heavy bleeding, irregular periods,
menopausal syndrome (in combination with oestrogen), or to postpone a period. It is also
commonly used to help prevent uterine hemorrhage in complicated non-surgical or pre-
surgical gynecologic cases.
Indications: to regulate menstrual cycle
Contents: Norethisterone 5 mg
HS Code: 30049099

300490  Other
3004099  Other

Duty Drawback: -

2012- 2013-
2012-2013 2013-2014 %Growth %Growth
2013 2014
1. USA 692,553.76 828,084.65 19.57 16,310.52 19,455.86 19.28
2. SOUTH AFRICA 107,628.55 198,417.36 84.35 2,633.03 4,843.38 83.95
3. RUSSIA 80,764.08 80,041.31 -0.89 3,280.55 2,361.99 -28.00
4. KENYA 70,077.96 76,782.37 9.57 2,768.15 2,407.90 -13.01
5. UK 55,884.64 62,434.13 11.72 3,558.03 5,489.30 54.28
6. NIGERIA 52,472.96 56,984.23 8.60 4,042.26 4,795.31 18.63
7. ZAMBIA 19,701.08 55,560.87 182.02 794.29 2,089.91 163.12
8. TANZANIA REP 38,027.79 50,004.74 31.50 1,284.99 2,744.00 113.54
9. UGANDA 30,262.34 47,987.67 58.57 1,190.51 1,751.19 47.10
10. GHANA 56,141.32 46,168.09 -17.76 3,094.27 3,171.20 2.49
11. CANADA 31,881.57 41,182.96 29.17 815.53 1,077.41 32.11
12. SRI LANKA DSR 30,895.57 37,907.46 22.70 2,186.07 2,524.10 15.46
13. GERMANY 46,706.23 36,989.36 -20.80 1,927.99 1,271.13 -34.07
14. ETHIOPIA 15,020.06 36,568.94 143.47 853.71 1,313.47 53.85
15. VIETNAM SOC REP 27,327.31 36,263.41 32.70 1,202.69 1,404.40 16.77
16. BRAZIL 33,577.30 33,090.45 -1.45 803.64 1,049.39 30.58
17. MYANMAR 22,465.71 32,790.88 45.96 1,660.65 1,870.17 12.62
18. UNSPECIFIED 6,138.44 29,545.73 381.32 94.57 491.57 419.81
19. PHILIPPINES 19,145.90 28,673.70 49.76 998.81 1,590.13 59.20
20. MALAWI 25,234.16 28,303.11 12.16 532.34 625.89 17.57
21. JAPAN 23,909.62 24,776.30 3.62 160.99 253.59 57.52
22. AUSTRALIA 23,028.79 24,576.59 6.72 1,190.70 1,148.50 -3.54
23. NETHERLAND 19,180.21 22,501.54 17.32 1,144.77 1,224.94 7.00
24. VENEZUELA 16,563.35 21,942.59 32.48 340.02 287.80 -15.36
25. FRANCE 18,707.79 21,177.94 13.20 1,087.64 1,204.06 10.70
26. ZIMBABWE 29,898.61 20,515.59 -31.38 991.70 551.07 -44.43
27. IRAN 14,891.06 19,839.02 33.23 531.42 461.85 -13.09
28. SLOVENIA 20,339.89 17,508.55 -13.92 180.81 170.34 -5.79
29. ANGOLA 8,500.99 17,469.38 105.50 1,933.87 1,971.35 1.94
30. BOTSWANA 13,954.67 17,043.56 22.14 407.31 408.35 0.25
31. MOZAMBIQUE 7,947.14 15,172.17 90.91 732.37 692.88 -5.39
32. THAILAND 14,726.30 14,322.03 -2.75 1,672.08 1,005.01 -39.89
33. BELGIUM 13,027.95 14,025.69 7.66 665.20 550.16 -17.29
34. UKRAINE 19,432.23 12,398.75 -36.19 1,318.39 649.37 -50.75
35. CAMEROON 6,333.50 12,136.34 91.62 561.95 515.07 -8.34
36. IRAQ 12,173.59 11,765.81 -3.35 964.35 3,642.48 277.71
37. BENIN 11,953.74 11,722.43 -1.94 1,788.94 1,343.02 -24.93
38. HUNGARY 9,147.12 11,487.78 25.59 303.45 175.60 -42.13
39. CONGO D. REP. 6,115.45 10,252.13 67.64 502.51 1,229.01 144.57
40. YEMEN REPUBLC 6,878.69 10,140.96 47.43 1,010.14 1,772.73 75.49
41. MALAYSIA 7,093.54 9,305.41 31.18 402.45 426.86 6.07
42. CHILE 9,364.61 9,287.44 -0.82 745.97 639.37 -14.29
43. CAMBODIA 4,940.22 9,075.52 83.71 1,637.75 1,112.61 -32.06
44. RWANDA 5,274.90 8,958.96 69.84 181.94 187.81 3.23
45. COLOMBIA 10,634.06 8,891.37 -16.39 290.98 537.15 84.60
46. SUDAN 5,955.72 8,848.51 48.57 317.13 561.60 77.09
47. KAZAKHSTAN 8,566.42 8,788.84 2.60 483.63 191.86 -60.33
48. MAURITIUS 6,362.29 8,718.65 37.04 338.15 381.41 12.79
49. ALGERIA 6,990.44 8,475.57 21.25 246.52 142.05 -42.38
50. BURKINA FASO 6,602.24 8,286.73 25.51 234.85 436.23 85.75
51. SINGAPORE 8,193.92 8,065.20 -1.57 475.96 239.43 -49.69
52. GUINEA 4,682.58 8,041.54 71.73 622.25 903.08 45.13
53. NIGER 4,657.54 7,906.28 69.75 609.26 1,039.53 70.62
54. U ARAB EMTS 4,518.91 7,257.22 60.60 321.82 485.60 50.89
55. DOMINIC REP 5,787.79 7,138.46 23.34 225.63 414.31 83.63
56. NEPAL 6,565.37 7,017.53 6.89 897.20 814.67 -9.20
57. LESOTHO 5,479.46 6,818.41 24.44 134.62 145.61 8.17
58. FINLAND 4,357.09 6,712.84 54.07 134.57 190.79 41.77
59. NAMIBIA 7,858.40 6,678.66 -15.01 170.48 305.54 79.23
60. NEW ZEALAND 4,387.30 6,029.27 37.43 271.56 334.58 23.20
61. ROMANIA 6,464.86 5,849.62 -9.52 153.07 131.42 -14.14
62. PERU 3,785.22 5,669.78 49.79 180.02 211.58 17.53
63. UZBEKISTAN 4,289.60 5,527.91 28.87 361.67 475.50 31.47
64. SPAIN 5,563.67 5,422.09 -2.54 373.76 217.96 -41.69
65. IRELAND 6,503.02 5,391.93 -17.09 289.74 429.08 48.09
66. JAMAICA 3,224.90 5,373.65 66.63 141.54 160.43 13.35
67. TURKMENISTAN 2,554.22 5,132.02 100.92 296.40 896.12 202.34
68. CONGO P REP 4,795.18 4,859.18 1.33 378.55 569.36 50.41
69. AFGHANISTAN TIS 3,590.56 4,802.71 33.76 1,235.67 716.39 -42.02
70. MALTA 4,624.39 4,739.99 2.50 240.15 214.20 -10.81
71. PORTUGAL 3,470.45 4,396.44 26.68 217.10 391.65 80.40
72. TAJIKISTAN 1,261.74 4,376.60 246.87 217.67 1,003.39 360.98
73. TOGO 3,393.99 4,324.64 27.42 417.86 311.77 -25.39
74. POLAND 5,883.06 4,301.39 -26.89 56.92 67.09 17.88
75. MOROCCO 2,848.00 4,220.51 48.19 71.84 65.72 -8.52
76. INDONESIA 1,878.31 4,098.59 118.21 343.50 516.88 50.47
77. SWAZILAND 6,849.66 4,056.04 -40.78 97.21 123.00 26.53
78. MEXICO 4,289.44 3,990.79 -6.96 150.44 135.18 -10.14
79. DENMARK 3,831.75 3,951.15 3.12 331.70 316.31 -4.64
80. HONG KONG 2,911.00 3,798.20 30.48 58.64 96.98 65.40
81. SWITZERLAND 3,019.41 3,752.81 24.29 168.06 75.26 -55.22
82. JORDAN 2,768.18 3,280.50 18.51 283.69 414.99 46.28
83. LEBANON 1,207.23 3,275.83 171.35 22.55 112.69 399.79
84. CHAD 2,265.74 3,254.05 43.62 153.97 180.82 17.44
85. BURUNDI 2,489.06 3,137.37 26.05 131.76 207.67 57.62
86. ITALY 3,861.46 3,080.80 -20.22 156.97 153.54 -2.19
87. SYRIA 1,989.47 2,985.12 50.05 56.29 1,311.66 2,230.15
88. CUBA 1,421.71 2,971.76 109.03 70.01 88.01 25.72
89. TURKEY 2,353.69 2,951.16 25.38 118.07 93.07 -21.17
90. KOREA RP 1,685.57 2,879.49 70.83 86.07 37.00 -57.01
91. CROATIA 2,926.87 2,866.50 -2.06 36.35 56.72 56.00
92. LIBYA 3,210.74 2,838.07 -11.61 293.09 241.72 -17.53
93. PAKISTAN IR 1,364.86 2,736.90 100.53 100.56 259.15 157.72
94. HAITI 3,327.33 2,729.73 -17.96 264.45 203.85 -22.92
95. MALDIVES 2,272.90 2,676.02 17.74 229.27 142.29 -37.94
96. PAPUA N GNA 1,699.71 2,655.24 56.22 507.83 271.15 -46.60
97. SWEDEN 1,909.81 2,643.73 38.43 84.61 162.15 91.66
98. TRINIDAD 2,049.75 2,581.34 25.93 133.08 107.03 -19.58
99. COSTA RICA 2,282.97 2,532.01 10.91 101.12 114.65 13.39
100. CZECH REPUBLIC 3,572.13 2,511.72 -29.69 69.92 102.86 47.12
101. MALI 2,823.88 2,481.35 -12.13 274.63 245.32 -10.67
102. SENEGAL 1,278.75 2,443.26 91.07 109.32 164.20 50.20
103. SOMALIA 1,219.63 2,442.00 100.23 412.96 424.46 2.79
104. LITHUANIA 1,332.39 2,418.36 81.50 49.66 76.08 53.18
105. ECUADOR 2,389.88 2,414.93 1.05 31.49 53.76 70.75
106. GUATEMALA 2,045.46 2,400.80 17.37 120.07 197.60 64.58
107. BELARUS 1,800.56 2,375.29 31.92 51.42 69.21 34.62
108. COTE D' IVOIRE 1,950.37 2,219.84 13.82 176.80 104.33 -40.99
109. PANAMA REPUBLIC 2,338.05 2,122.79 -9.21 71.16 77.59 9.04
110. BULGARIA 1,573.47 2,066.15 31.31 50.13 75.87 51.34
111. SIERRA LEONE 1,671.71 1,898.23 13.55 635.47 251.41 -60.44
112. MADAGASCAR 2,091.06 1,890.17 -9.61 296.13 186.50 -37.02
113. LATVIA 986.52 1,874.87 90.05 123.82 147.18 18.87
114. GUYANA 1,514.10 1,855.33 22.54 110.13 161.21 46.39
115. EL SALVADOR 1,734.62 1,836.62 5.88 115.64 152.59 31.96
116. ERITREA 996.78 1,813.21 81.91 78.97 94.44 19.59
117. GEORGIA 1,602.58 1,798.71 12.24 165.77 121.86 -26.49
118. AUSTRIA 2,747.78 1,771.75 -35.52 38.53 42.64 10.67
119. BOLIVIA 2,141.28 1,738.85 -18.79 243.16 98.77 -59.38
120. LIBERIA 1,622.98 1,606.53 -1.01 431.41 152.57 -64.63
121. GABON 1,308.66 1,569.82 19.96 46.05 32.20 -30.08
122. KYRGHYZSTAN 914.45 1,453.84 58.99 157.90 117.46 -25.61
123. OMAN 1,050.40 1,391.37 32.46 35.84 47.68 33.02
124. TAIWAN 758.20 1,250.84 64.98 13.65 19.49 42.73
125. NICARAGUA 1,540.09 1,205.88 -21.70 208.28 155.84 -25.18
126. C AFRI REP 1,419.97 1,146.73 -19.24 29.29 74.92 155.75
127. EGYPT A RP 1,173.87 1,127.16 -3.98 66.10 45.65 -30.93
128. CHINA P RP 747.07 1,126.88 50.84 18.09 51.68 185.69
129. SERBIA 1,124.10 8.47
130. MAURITANIA 419.18 1,027.62 145.15 58.64 131.51 124.27
131. UNION OF SERBIA & 1,483.07 1,026.94 -30.76 45.60 58.18 27.58
MONTENEGRO
132. MOLDOVA 967.09 956.49 -1.10 45.38 46.49 2.44
133. GAMBIA 554.55 953.30 71.91 81.77 74.10 -9.38
134. URUGUAY 1,361.38 952.69 -30.02 14.94 12.26 -17.96
135. VANUATU REP 1,062.00 952.37 -10.32 9.64 11.16 15.83
136. HONDURAS 2,773.69 827.07 -70.18 107.77 87.31 -18.99
137. ARGENTINA 651.59 820.23 25.88 5.60 11.44 104.16
138. AZERBAIJAN 1,451.50 791.54 -45.47 101.40 69.30 -31.66
139. SEYCHELLES 549.40 790.03 43.80 19.28 41.03 112.84
140. SAUDI ARAB 549.71 730.05 32.81 41.23 74.25 80.09
141. FIJI IS 702.67 633.50 -9.84 108.39 38.99 -64.03
142. CYPRUS 683.98 613.09 -10.36 12.05 17.41 44.44
143. BANGLADESH PR 804.09 592.66 -26.30 21.23 21.40 0.80
144. PARAGUAY 729.76 584.87 -19.85 20.48 10.71 -47.69
145. KOREA DP RP 521.52 478.88 -8.18 36.74 35.85 -2.41
146. SLOVAK REP 1,753.16 471.52 -73.10 24.36 9.35 -61.62
147. GUINEA BISSAU 263.05 441.41 67.80 19.11 36.00 88.35
148. BAHAMAS 466.69 412.48 -11.62 14.67 10.15 -30.80
149. BHUTAN 397.77 384.62 -3.31 35.51 108.86 206.54
151. MONGOLIA 223.26 351.14 57.28 16.39 29.20 78.22
152. BAHARAIN IS 427.79 347.19 -18.84 8.98 5.73 -36.21
153. SURINAME 155.89 344.39 120.92 8.37 7.94 -5.15
154. LAO PD RP 160.52 314.96 96.21 9.63 10.87 12.89
155. BOSNIA-HRZGOVIN 256.97 302.82 17.84 9.72 12.46 28.16
156. MACEDONIA 288.32 302.51 4.92 4.23 4.11 -2.77
157. EQUTL GUINEA 441.60 295.74 -33.03 57.52 31.80 -44.73
158. KUWAIT 122.60 287.74 134.69 9.81 19.78 101.72
159. ISRAEL 208.76 279.19 33.74 7.45 21.08 182.81
160. DJIBOUTI 192.69 271.73 41.02 39.83 8.04 -79.81
161. ARMENIA 123.86 234.24 89.11 11.06 12.82 15.99
162. GREECE 822.45 216.21 -73.71 39.71 6.05 -84.76
163. ST LUCIA 97.19 188.31 93.75 5.26 11.35 115.78
164. BARBADOS 616.58 131.34 -78.70 20.61 5.82 -71.75
165. MICRONESIA 90.81 101.34 11.60 1.88 3.67 95.37
166. BELIZE 141.73 97.32 -31.34 7.51 2.83 -62.26
167. FR GUIANA 85.08 1.30
168. QATAR 164.49 85.06 -48.29 14.84 8.58 -42.23
169. TONGA 19.55 80.00 309.30 0.19 12.42 6,576.34
170. SOLOMON IS 53.16 71.91 35.29 7.39 2.09 -71.66
171. COMOROS 13.72 70.17 411.31 1.30 36.06 2,682.41
172. ANTIGUA 52.77 65.67 24.45 1.30 1.34 2.85
173. CAYMAN IS 19.26 63.95 232.07 0.37 2.28 521.58
174. SAMOA 39.63 57.12 44.15 0.99 10.35 943.85
175. ESTONIA 184.33 51.87 -71.86 5.84 5.30 -9.20
176. MACAO 73.51 51.76 -29.59 3.22 1.25 -61.20
177. CAPE VERDE IS 29.07 48.20 65.83 0.39 1.13 190.75
178. ST KITT N A 38.86 43.06 10.80 0.95 2.03 114.24
179. TUNISIA 204.06 34.09 -83.29 1.89 0.79 -58.28
180. ST VINCENT 39.96 33.06 -17.28 0.83 0.78 -6.83
181. NORWAY 67.76 31.29 -53.82 10.77 1.05 -90.22
182. GRENADA 22.56 26.43 17.16 0.88 0.99 12.12
183. SAO TOME 14.62 26.07 78.27 0.23 0.76 234.21
184. MONTENEGRO 25.56 0.33
185. DOMINICA 326.29 23.11 -92.92 10.05 1.06 -89.45
186. ALBANIA 57.26 18.76 -67.23 1.77 0.48 -72.82
187. LUXEMBOURG 16.91 18.51 9.50 0.09 0.16 75.56
188. TIMOR LESTE 311.06 17.46 -94.39 14.21 2.18 -84.65
189. BR VIRGN IS 0.08 13.66 17,168.14 0.02 0.16 695.00
190. PALAU 16.00 12.14 -24.09 0.14 0.11 -18.84
191. KIRIBATI REP 3.50 11.70 234.44 0.90 0.68 -25.00
192. MARSHALL ISLAND 12.87 7.93 -38.35 0.33 0.25 -23.31
193. ICELAND 35.73 4.61 -87.09 0.55 0.32 -42.55
194. PUERTO RICO 0.42 4.38 954.08 0.02 0.25 1,150.00
195. BRUNEI 2.30 0.06
196. GUAM 103.37 2.02 -98.05 3.32 0.38 -88.57
197. MONTSERRAT 0.64 1.84 188.79 0.00 0.05 1,700.00
198. NAURU RP 1.76 0.03
199. ANGUILLA 1.03 1.70 64.98 0.03 0.03 -12.12
200. GIBRALTAR 1.67 0.04
201. TUVALU 0.44 0.03
202. REUNION 0.09 0.02
203. PANAMA C Z 0.02 0.00
Total 2,086,427.98 2,560,318.81 22.71

2013- 2013-
2012-2013 %Growth 2012-2013 %Growth
2014 2014
1. SWITZERLAND 42,316.70 43,137.38 1.94 43.75 57.57 31.61
2. GERMANY 26,205.81 35,640.97 36.00 21.43 97.39 354.53
3. USA 29,105.65 32,629.05 12.11 27.80 45.67 64.27
4. ITALY 25,638.39 23,354.98 -8.91 18.00 38.91 116.19
5. UK 18,735.12 21,618.33 15.39 16.37 39.12 139.00
6. FRANCE 18,984.63 15,853.37 -16.49 18.72 24.01 28.28
7. NETHERLAND 8,196.64 10,341.38 26.17 6.83 13.94 104.07
8. BELGIUM 5,680.04 6,602.63 16.24 9.81 8.71 -11.16
9. IRELAND 8,403.77 5,705.67 -32.11 5.06 7.09 39.93
10. CANADA 2,243.56 5,163.37 130.14 2.94 12.28 317.87
11. FINLAND 2,101.45 5,086.05 142.03 1.95 20.69 963.80
12. CHINA P RP 3,585.55 4,574.38 27.58 6.53 25.94 297.15
13. SWEDEN 3,824.99 4,515.30 18.05 5.26 21.88 315.74
14. DENMARK 4,560.32 4,265.60 -6.46 4.06 4.14 1.87
15. PUERTO RICO 2,065.22 3,915.67 89.60 1.33 7.16 439.59
16. MEXICO 2,126.68 2,740.39 28.86 2.58 2.90 12.57
17. JAPAN 5,269.03 2,334.33 -55.70 5.24 2.68 -48.92
18. SPAIN 1,775.61 1,589.65 -10.47 2.91 2.99 2.92
19. AUSTRALIA 888.58 1,549.93 74.43 1.64 2.13 30.24
20. AUSTRIA 2,214.01 1,486.62 -32.85 2.61 1.65 -36.75
21. SINGAPORE 1,025.68 1,312.70 27.98 1.16 2.64 126.44
22. SOUTH AFRICA 791.27 947.76 19.78 4.91 0.80 -83.75
23. KOREA RP 989.10 785.44 -20.59 0.91 0.88 -3.07
24. MALAYSIA 2,076.59 720.81 -65.29 2.13 18.88 785.19
25. HUNGARY 126.44 634.29 401.63 0.61 0.84 39.50
26. TAIWAN 75.77 521.65 588.45 0.07 0.74 909.59
27. BRAZIL 454.66 457.00 0.52 0.49 0.36 -26.83
28. MALTA 319.27 432.33 35.41 0.58 0.32 -45.42
29. UNSPECIFIED 96.37 270.73 180.91 0.40 0.20 -49.88
30. CZECH REPUBLIC 129.80 194.77 50.05 1.22 11.37 833.58
31. ISRAEL 405.25 188.96 -53.37 0.87 1.07 22.08
32. URUGUAY 114.54 0.11
33. TURKEY 192.09 108.00 -43.78 0.08 0.32 289.02
34. RUSSIA 3.86 95.18 2,363.20 0.00 0.08 1,400.00
35. POLAND 176.58 39.89 -77.41 0.16 0.08 -47.77
36. ARGENTINA 30.30 36.34 19.91 0.03 0.01 -75.86
37. SLOVAK REP 26.31 0.03
38. PHILIPPINES 39.95 21.95 -45.07 0.07 0.02 -72.60
39. BULGARIA 4.33 21.93 406.41 0.00 0.02 375.00
40. PORTUGAL 29.63 20.98 -29.18 0.04 0.02 -46.34
41. HONG KONG 114.69 18.48 -83.89 0.11 0.01 -90.83
42. THAILAND 6.72 14.58 116.99 0.01 0.01 0.00
43. CYPRUS 3.83 12.47 225.47 0.00 0.02 325.00
44. LITHUANIA 11.05 0.01
45. U ARAB EMTS 10.46 10.21 -2.40 0.00 0.01 20.00
46. NEW ZEALAND 7.69 6.60 -14.24 0.01 0.01 100.00
47. MALDIVES 6.03 0.01
48. CHILE 63.37 5.01 -92.09 1.04 0.00 -99.52
49. LIBERIA 4.84 0.00
50. GREECE 7.85 2.38 -69.73 0.01 0.01 -46.15
52. ICELAND 15.80 1.84 -88.37 0.01 0.00 -70.00
53. SLOVENIA 21.89 1.82 -91.70 0.09 0.00 -97.73
55. INDONESIA 0.99 1.00 1.22 0.00 0.00 0.00
56. LATVIA 6.21 0.97 -84.42 0.01 0.00 -87.50
57. ROMANIA 11.08 0.79 -92.84 0.01 0.01 -53.85
58. MOROCCO 0.10 0.62 546.69 0.00 0.01 175.00
59. GEORGIA 0.42 0.00
60. KENYA 0.38 0.14 -62.49 0.00
61. CROATIA 0.05 0.02 -58.08
62. COSTA RICA 0.02
63. ALGERIA 0.54 0.00
65. GABON 0.30
66. JORDAN 0.09
67. JAMAICA 0.69
68. KOREA DP RP 6.35 0.00
69. NAMIBIA 0.51
71. PERU 42.03 0.04
72. SAUDI ARAB 1.18 0.01
74. SWAZILAND 57.13 0.04
75. VENEZUELA 3.37
76. ZAMBIA 1.61 0.00
77. UKRAINE 0.16
Total 221,274.41 239,159.18 8.08
Countries: USA, South Africa, Russia, Kenya, UK, Nigeria, Zambia, Tanzania, Uganda,
Ghana, Canada, Sri Lanka, Germany, Ethiopia, Vietnam
Region: N. America, Africa, Russia, Europe
Pharmexcil:
http://www.ipapharma.org/regulations.aspx
http://www.pharmexcil.com/members
USA Regulations:
Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 60(RE-2010) /2009-2014
New Delhi, Dated the 30th June, 2011
Subject: Procedure relating to export of pharmaceuticals and drugs.
In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy,
2004-2009, as amended from time to time, Director General of Foreign Trade, notifies with
immediate effect, procedures/guidelines to strengthen the enforcement mechanism available
under the Drugs and Cosmetics Act, 1940 to ensure that counterfeit drugs do not get exported out
of the country.
2. Procedure for export of Drugs & Pharmaceuticals, covered under the provisions of Drugs
& Cosmetics Act, 1940 and the rules made there under, shall be as given below:
3. Every exporter of Drugs & Pharmaceuticals at the time of shipment shall submit, along
with other required documents, the following:
i. A copy of Certificate of Analysis issued by the manufacturer for the subject product;
or
ii. A copy of Certificate of Analysis issued by approved laboratory of the importing

country / FDA;
or
iii. A copy of Certificate of Analysis issued by a laboratory approved by Drugs Controller

under Drugs & Cosmetics Act, 1940 and the rules made there under.
4. Wherever required the officials of the Drug Control Department posted at the port offices
may retain a sample of the subject consignment for the purpose of reference and tracking
of the manufacturer / exporter of the subject product.
(Anup K.Pujari)
Director General of Foreign Trade
U.S. FDA Drug Establishment

Registration and Listing Requirements
Owners or operators of all drug establishments, not exempt under section
510(g) of the Food, Drug, and Cosmetic Act (Act), that engage in the
manufacture, preparation, propagation, compounding, or processing of a drug
or drugs shall register and submit a list of every drug in commercial
distribution.
Manufacturing or processing means the manufacture, preparation, propagation,

compounding, or processing of a drug or drugs as used in section 510 of the
Act and is the making by chemical, physical, biological, or other procedures of
any articles that meet the definition of drugs in section 201(g) of the Act. The
term includes manipulation, sampling, testing, or control procedures applied to
the final product or to any part of the process.
The term "drug" means (A) articles recognized in the official United States
Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or
official National Formulary, or any supplement to any of them; and (B) articles
intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals; and (C) articles (other than food) intended to
affect the structure or any function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in clause
(A), (B), or (C).
Registrar Corp helps businesses comply with U.S. FDA Drug registration and
listing requirements. For U.S. FDA Drug assistance, simply click the U.S. FDA
Drug category applicable to your drug products.
CDER Small Business and Industry Assistance:

Import and Export of Human Drugs and Biologics
 Imports
 Exports
 Related Links
Imports
The Federal Food, Drug, and Cosmetic Act (Act) prohibits the interstate shipment (which includes importation and
exportation) of unapproved new drugs. Thus, the importation of new drugs that lack FDA approval, whether for personal
use or otherwise, violates the Act. Unapproved new drugs include any drugs--including foreign-made versions of U.S.
approved drugs--that have not been manufactured in accordance with FDA approval.
Imported products regulated by the FDA are subject to inspection at the time of entry by the U.S. Bureau of Customs &
Border Protection (Customs). Shipments not found to comply with the law are subject to detention. They must be brought
into compliance, destroyed, or re-exported. Under the Act, FDA may refuse admission to any drug that "appears" to be
unapproved, misbranded, or adulterated, placing the burden on the importer to prove that specific drugs sought to be
imported are not in violation of the Act. For example, without evidence that specific drugs sought to be imported have
been manufactured pursuant to an approved new drug application or abbreviated new drug application, in the
manufacturing facility permitted under the application, the drugs might appear to be unapproved new drugs.
The importation and exportation of controlled substances requires compliance with provisions enforced by the U.S. Drug
Enforcement Administration (DEA). Information can be obtained at the DEA Office of Diversion Control website. Also, the
United States Department of Agriculture (USDA) has certain requirements for the importation and exportation of animal-
derived products, such as biological drugs. Information can be obtained at the USDA Veterinary Services Import and
Export website.
Information about how drugs are approved in the U.S. can be found on the CDER Small Business and Industry
Assistance (CDER SBIA) website. A draft guidance, Unapproved Drugs - Compliance Policy Guide (PDF - 66KB), on
current agency policy regarding drugs marketed in the u.s. that lack required fda approval is available. the following
information on imports/exports contains references to the act and regulations set forth at title 21, code of federal
regulations (cfr) (regulations of the food and drug administration). you can download the referenced sections of the act or
the regulations by using this link to the act: Federal Food, Drug, and Cosmetic Act and this link to the regulations: Code of
Federal Regulations.
Registration of Foreign Manufacturers
Effective May 24, 2002, all foreign drug establishments whose products are imported or offered for import into the United
States are required to register with FDA: Federal Register Notice (PDF - 136KB). Foreign firms must also identify a
United States agent and submit a list of every drug in commercial distribution. For additional information, see:
 Drug Registration and Listing website

 Drug Listing Requirements for Foreign Drug Establishments (Code of Federal Regulations)
Back to Top
FDA's Import Program / General Procedures
Entry of Product into the United States
To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her
representative, must file an entry notice and an entry bond with Customs pending a decision regarding the admissibility of
the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs. FDA is notified
by Customs of the product’s entry and makes a decision as to its admissibility. If FDA does not wish to examine the entry,
the product is allowed to proceed into United States commerce. Generally, if FDA decides to examine an entry, an
agency representative will collect a sample from the shipment for laboratory evaluation. If the analysis indicates that the
product complies with the Act and related regulations, the shipment may be released into United States commerce. If
there is a violation, the product will be detained. If not brought into compliance, the product will be refused admission.
When a sample of an article offered for import has been requested by FDA, the owner or consignee must hold the
shipment and not distribute it until further notice is received regarding the results of the examination of the sample. If it
appears that the article is violative, FDA issues a Notice of Detention and Hearing to the owner or consignee of the article,
specifying a place and a time period whereby the individual may introduce testimony concerning the acceptability of the
product.
For specific information on Customs procedures, requirements, forms, and other mattters, contact your local Customs
office. Information is also available at the U.S. Customs website.
Refusal of Admission
Section 801 of the Act directs FDA to refuse admission to any article that appears to be in violation of the Act. If
admission of the product is refused, the importer must either re-export or destroy the product under Customs or other
approved supervision. If the product is not destroyed or re-exported, Customs issues a notice for redelivery to the
importer of record. Failure to redeliver the refused product may result in Customs assessing liquidated damages against
the importer's bond.
Application to Recondition
If admission is refused, the importer may submit an application to recondition the product to bring it into compliance with
the Act. The owner or consignee also may submit an application to FDA to relabel or perform other actions to bring the
article into compliance. An application for authorization to relabel or perform other actions to bring the article into
compliance must contain a detailed proposal of the steps to be taken and specify the place where the operations will be
carried out and the approximate time for completion. All applications to recondition a product are subject to FDA review
and approval. See the Regulatory Procedures Manual (Chapter 9) for details on reconditioning.
Detention Without Physical Examination
In some instances, a product may be detained without physical examination as soon as it is offered for entry into the
United States. This process is based on history and/or other information indicating that the product may be violative.
When a product is subject to detention without physical examination, the shipper or importer must prove that the product
meets FDA requirements. Occasionally, when the violative conditions appear to be geographically widespread, FDA
identifies products from an entire country or geographic region for detention without physical examination. See
the Regulatory Procedures Manual (Chapter 9) for details on Automatic Detention.
Import Alerts
The purpose of an Import Alert is to identify and disseminate import information (such as problems and violative trends) to
FDA personnel, thus providing more uniform and effective import coverage. Import Alerts identify problem commodities
and/or shippers and provide guidance to FDA personnel regarding the importation of the products and/or firms covered in
the alert. They may also concern products or manufacturers that have met the criteria for detention without physical
examination. See the Regulatory Procedures Manual (Chapter 9).
For additional information or questions regarding detention without physical examination or import alerts, contact the
Division of Import Operations and Policy (DIOP), HFC-170, 5600 Fisher Lane, Rockville, MD 20857.
Computerization
To assure the expeditious handling of imported products, FDA has automated its import operations. By combining FDA's
Operational and Administrative System for Import Support (OASIS) and Customs' Automated Commercial System (ACS),
an FDA reviewer can more efficiently evaluate and process each import entry. The import filer transmits the required
shipment-specific FDA data into the ACS. Within several minutes, the filer receives notification that either their shipment
has been released or FDA wishes to further review the entry. This system provides FDA with immediate data on imported
products, provides information on potential problems, and maintains national historical data files to develop profiles on
specific products, shippers, and manufacturers. Eventually all filers processing entries through Customs' ACS will provide
FDA information electronically.
For additional information on the Import Program's general procedures, see
 Regulatory Procedures Manual (Chapter 9)
 Investigations Operations Manual, Chapter 6, Imports
Back to Top
Import of Active Pharmaceutical Ingredients (APIs)
Import Alert #66-66 provides useful guidance on the import of APIs. This guidance includes information on the detention
of APIs, when they can be detained without physical examination, and the type of evidence needed to obtain their release.
For additional information, see the Federal Register Notice (PDF -121KB).
Import of Over-the-Counter (OTC) Drug Products
An OTC Drug Product is a product marketed for use by the consumer without the intervention of a health care
professional to obtain the product. In addition to marketing under an approved new drug application or abbreviated new
drug application, OTC drug products can be marketed in compliance with an OTC monograph regulation. OTC
monographs represent regulatory standards for the marketing of non-prescription drug products without an approved new
drug application. An OTC drug can be imported into the United States under an approved new drug application, an
approved abbreviated new drug application, or in compliance with an OTC monograph.
 The OTC monographs and ingredients covered by the monographs are provided by the following
website: Status of OTC Rulemakings
 The Small Business Assistance website provides the requirements for the approval of a new drug application or
an abbreviated new drug application
Both websites provide contact information for inquiries.
Currently there are still several categories of OTC drug products that are not subject to final regulations. Proposed
monographs at the OTC website cited above provide guidance for the marketing of products not yet subject to a final rule.
Import for Export
Import for Export refers to the provision of the FDA Export Reform and Enhancement Act of 1996 that allows the
importation of certain articles that are unapproved or otherwise do not comply with the Act, provided that those articles are
further processed or incorporated into products that will be exported from the United States by their initial owner or
consignee. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act),
effective September 9, 2002, added some requirements to the Import for Export provisions. Information on Import for
Export can be found in the Regulatory Procedures Manual (Chapter 9).
Back to Top
Exports
Export of Drugs and Biologics Under the FDA Export Reform and Enhancement Act of 1996
A draft guidance document is available that summarizes and explains the basic requirements and procedures for
exporting human drugs (also drug components) and biologics that may not be sold or distributed in the United States.
This guidance document also summarizes and explains the requirements for exporting drugs that are approved for
marketing in the United States, but which are being exported for an unapproved use. The draft guidance document is
available online: Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996. It also
provides contacts for additional information.
Export Certificates for Drugs/Biologics
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a
certification relating to products subject to the Act. An export certificate is a document prepared by FDA containing
information about a product's regulatory or marketing status.
The following websites provides information and contacts on export certificates for drugs and biologics:
 FDA Export Information: Exports and Export Certificates
 Guidance on FDA Export Certificates
 Certificate of a Pharmaceutical Product application guidelines and instructions (PDF - 33KB)
For general information, refer to:
 Compliance Policy Guide Manual for FDA Staff
 FDA Import Program website
Back to Top
The import program managers in FDA's District Offices are an additional point of contact.
See ORA Field Program Monitors (Import Program Managers section) for contact information.

Related Links
 FDA Import Program website
 Importing Prescription Drugs - information from FDA for consumers
 U.S. Export Assistance Centers
Exports Under the FDA Export Reform and

Enhancement Act of 1996
Guidance for Industry - Exports Under the FDA Export
Reform and Enhancement Act of 1996

<< Return to Import and Export Guidance Documents

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Submit written comments at any time. Submit comments to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the
Docket No. 1998D-0307.
For questions regarding this document contact the Center for Veterinary Medicine at 301-594-1785, Center for
Biologics Evaluation and Research at 301-827-6201, Center for Devices and Radiological Health at 301-594-4699,
Center for Drug Evaluation and Research at 301-796-3218, or Center for Food Safety and Applied Nutrition at 1-888-723-
3366.
Additional copies are available from:
Office of International Programs (HFG-1)
Food and Drug Administration
5600 Fishers Lane,
Rockville, MD 20857
(Tel) 301-827-4480
http://www.fda.gov/ohrms/dockets/default.htm
U.S. Department of Health and Human Services
Office of International Programs
July 23, 2007

Table of Contents

I. Introduction
II. Terms Used in This Guidance
III. Quick Guide
IV. Statutory Background
A. Historical Background - Exports of Drugs and Biological Products That May Not Be Sold in the United States
B. Historical Background - Exports of Animal Drugs That May Not Be Sold in the United States
C. Historical Background - Exports of Devices That May Not Be Sold in the United States
D. Enactment of the FDA Export Reform and Enhancement Act of 1996
V. General Requirements for Products Exported Under Section 801(e) (1) of the Act
A. Summary of Section 801(e)(1) of the Act
B. Determining Compliance with Section 801(e)(1) of the Act
1. Meeting a Foreign Purchaser’s Specifications
2. Not in Conflict with the Laws of the Importing Country
3. Shipping Package Labeling Showing that the Product is Intended for Export
4. Product is Not Sold or Offered for Sale in the United States
C. Special Restrictions on Animal Drugs
D. Special Requirements for Certain Devices
E. Special Requirements for Partially Processed Biological Products
1. What Constitutes a Partially Processed Biological Product?
2. cGMP Requirements
3. Additional Requirements Under Section 351(h) of the Public Health Service (PHS) Act
VI. Labeling Requirements for Drugs and Biological Products Exported Under Section 801(e) (1) of the Act - Section
801(f) of the Act
VII. Exports of Unapproved Drugs, Biological Products, and Devices Under Section 802(b) of the Act
A. Drugs and Biological Products
B. Devices
C. Basic Requirements for All Products Exported Under Section 802 of the Act
D. Exports of Unapproved New Drugs, Biological Products, and Devices to a Listed Country - Section 802(b) (1) (A) of the
Act
E. Expanding the List of Countries in Section 802(b) (1) (A) of the Act
F. Exports of Unapproved New Drugs and Biological Products to an Unlisted Country - Section 802(b)(2) and (b)(3) of the
Act
VIII. Exports of Unapproved Drugs and Devices for Investigational Use to Listed Countries Under Section 802(c) of the
Act
A. Historical Background
B. Impact of the 1996 Amendments on Drug Exports for Investigational Use
C. Impact of the 1996 Amendments on Device Exports for Investigational Use
IX. Exports of Unapproved Drugs and Devices in Anticipation of Foreign Approval - Section 802(d) of the Act
X. Exports of Drugs and Devices for Diagnosing, Preventing, or Treating a Tropical Disease or a Disease “Not of
Significant Prevalence in the United States” - Section 802(e) of the Act
XI. Export Notification and Recordkeeping Under Section 802(g) of the Act
A. The Content of the Simple Notification
B. Where to Send the Simple Notification
C. Recordkeeping
XII. For Further Information, Contact

Guidance for Industry: Exports Under the FDA Export

Reform and Enhancement Act of 1996 1
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic and replaces
FDA’s previous guidance on exports entitled, “A Review of FDA’s Implementation of the Drug Export Amendments of
1986.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this
guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this
guidance.

I. Introduction

This guidance document summarizes and explains the basic requirements and procedures under the FDA Export Reform
and Enhancement Act of 1996 (Public Law 104-134, as amended by Public Law 104-180) for exporting human drugs,
animal drugs, biological products, devices, food, food additives, color additives, and dietary supplements that may not be
sold or distributed in the United States. This law amended sections 801 and 802 of the Federal Food, Drug, and Cosmetic
Act (the Act), as well as section 351(h) of the Public Health Service Act, simplifying the requirements for exporting
unapproved human drugs, biological products, and devices. In addition, the FDA Export Reform and Enhancement Act
substantially reduced the requirements for exporting unapproved new animal drugs and provided a new option for
exporting unapproved devices.
The 1996 Amendments did not change the general export requirements in section 801(e)(1) of the Act with respect to
foods or cosmetics. This document provides guidance on these general export requirements under section 801(e)(1) of
the Act for all products that are subject to this provision. Guidance is also provided on the export requirements for
unapproved human drugs, biological products and devices in sections 801 and 802 of the Act resulting from the 1996
Amendments.
If a product meets the Act’s requirements for sale and distribution in the United States, the Act has no additional
restrictions on its exportation (i.e., sections 801 and 802 of the Act do not apply to such exports). However, other federal
statutes or regulations administered by other federal agencies (such as the Department of Commerce) may apply.
This guidance document does not address export certificates and any associated fees. Information on these subjects can
be found in FDA’s Compliance Policy Guide 7150.01, “Certification for Exports” , and FDA’s Guidance for Industry, “FDA
Export Certificates”.
This guidance document also does not address the importation and subsequent exportation of certain articles under
section 801(d)(3) and (d)(4) of the Act, which is sometimes referred to as the “import-for-export” provision. Although the
draft guidance document on the 1996 Export Reform and Enhancement Act discussed the importation of certain
components, parts, and accessories of human drugs, biological products, devices, food additives, color additives, and
dietary supplements for further processing or incorporation into products intended for export, the Public Health Security
and Bioterrorism Preparedness and Response Act of 20022significantly revised section 801(d)(3) of the Act. The revised
statutory provision went into effect on September 9, 2002, and FDA announced, in a September 18, 2002, Federal
Register notice (67 FR 58810), that it had revised the relevant FDA Regulatory Procedures Manual chapter to incorporate
those changes.
Please note that a firm or product may be subject to additional statutory or regulatory requirements beyond
those described in this guidance. For example, a firm may be subject to the establishment registration requirements
under section 510 of the Act (21 U.S.C. 360). Please contact the appropriate FDA center for additional information.
Additionally, exports involving controlled substances may be subject to requirements administered by the Drug
Enforcement Administration. Exports of certain products or exports to specific countries may be subject to licensing and
other requirements administered by the Department of Commerce or the Bureau of the Census.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead,
guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless
specific regulatory or statutory requirements are cited. The use of the word shouldin Agency guidances means that
something is suggested or recommended, but not required.

II. Terms Used in This Guidance

This guidance uses the following terms:
“Act” means the Federal Food, Drug, and Cosmetic Act. Citations to specific sections of the Act will use the numerical
sequence specified in the Act rather than the section numbers used in the United States Code (U.S.C.).
“cGMP” means current good manufacturing practice. For drugs and most biological products, cGMP regulations can be
found at parts 210 and 211 (21 CFR Parts 210 and 211). For devices and biological products regulated as devices, cGMP
regulations (referred to as quality systems regulations or QSR) can be found at part 820 (21 CFR Part 820). For blood and
blood components, additional regulations can be found at part 606 (21 CFR Part 606).
“FDA” or “agency” means the Food and Drug Administration.
“IDE” means an investigational device exemption application. These are applications containing requests to use an
unapproved device in clinical tests using human subjects. The regulations are authorized under section 520(g) of the Act
(21 U.S.C. 360(g)), and the implementing regulations can be found at part 812 (21 CFR Part 812).
“IND” means an investigational new drug application. These applications are usually required for persons who intend to
conduct clinical investigations involving products subject to section 505 of the Act (21 U.S.C. 355) or to the licensure
provisions in section 351 of the Public Health Service Act (42 U.S.C. 262). The IND regulations are authorized by section
505(i) of the Act and are found at part 312 (21 CFR Part 312).
“1986 Amendments” means the Drug Export Amendments Act of 1986 (Public Law 99-960). The FDA Export Reform and
Enhancement Act of 1996 revised or eliminated most provisions in the 1986 Amendments.
“1996 Amendments” means the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134 and amended
by Public Law 104-180).
“PHS Act” means the Public Health Service Act (42 U.S.C. 201 et seq.). Citations to specific sections of the PHS Act will
use the numbers specified in the PHS Act rather than the section numbers used in the U.S. Code.
“PMA” means a premarket approval application. This is a marketing application for certain devices under section 515 of
the Act. The PMA regulation is at 21 CFR part 814.
“312 Program” means the regulatory program used by FDA for permitting the exportation of investigational drugs or
biological products for clinical use in foreign countries. The principal statutory authority for the 312 Program is section
505(i) of the Act, and the implementing regulation is at 21 CFR § 312.110.

III. Quick Guide

The chart below can be used to identify possible export routes for FDA-regulated products in various circumstances. You
should examine the requirements of the cited export provision or provisions carefully to determine whether you can export
a particular product in compliance with those requirements.

Type of Status Under the Intended for Approved Possible Section Sections Special
Product Federal Food, Drug, Commercial / Legally Export 801 (e) 802 (f) Requiremen
and Cosmetic Act or Distribution Marketed Provision (1) and 802 ts
the Public Health or in a Listed Options applies (g)
Service Act (PHSA) Investigation Country and ? apply?
al Use Relevant
Guidance
Document
Chapter
Drug Approved as Commercial n/a 801(f) Yes No –

(includin distributed in the U.S., See part VI
g but to be exported with
Biologic different or additional Yes 802 (b) (1) Yes Yes –
al labeling requirements See part
Products or conditions for use VII C and D
)
Drug Requires approval Commercial Yes 802 (b) (1) Yes Yes –
(includin under section 505 of See part
g the Act or licensing VII C and D
Biologic under section 351 of
al the PHSA, and does
Products not haveOR not in
) compliance with
approval – includes
drugs not in
compliance with OTC
monographs – or
licensing
Drug Requires approval Investigationa Yes 802 (b) (1) Yes Yes -
(includin under section 505 of l See part
g the Act or licensing VII C and D
Biologic under section 351 of
al the PHSA, and does n/a 802(c) Yes Yes, -
Products not haveOR not in See part except
) compliance with VIII for
approval – includes notificatio
drugs not in n under
compliance with OTC (g)
monographs – or
licensing
Drug Requires approval Investigationa n/a 21 CFR - - See

(includin under section 505 of l 312.110 provisions of
g the Act or licensing 312.110 for
Biologic under section 351 of specific
al the PHSA, and does options and
Products not haveOR not in requirements
) compliance with
approval - includes
drugs not in
compliance with OTC
monographs - or
licensing
Drug Requires approval Commercial, No, but 802 (d) Yes Yes, –
(includin under section 505 of but exported exported in See part IX except
g the Act or licensing to a listed anticipation for
Biologic under section 351 of country for of market notificatio
al the PHSA, and does further authorizatio n under
Products not haveOR not in formulation, n (g)
) compliance with processing,
approval – includes etc.
drugs not in
compliance with OTC
monographs – or
licensing
Drug Requires approval Commercial; No 802 (b) (2) Yes Yes, Both require
(includin under section 505 of exported to or 802 (b) except a submission
g the Act or licensing an unlisted (3) for notifi- to FDA and a
Biologic under section 351 of country See part cation determination
al the PHSA, and does VII F under (g) by FDA
Products not haveOR not in before the
) compliance with export can
approval – includes begin
drugs not in
compliance with OTC
monographs– or
licensing
Drug Requires approval Intended for No 802(e) is Yes Yes, Requires

(includin under section 505 of use in a an option except approval of
g the Act or licensing tropical for an for an
Biologic under section 351 of disease or export to notificatio application to
al the PHSA, and does other disease an unlisted n under FDA before
Products not haveOR not in not of country if (g) the export
) compliance with significant the product can begin
approval – includes prevalence in does not
drugs not in the U.S. qualify for
compliance with OTC export
monographs – or under any
licensing other
provision of
section 802
of the Act
See part X
Drug Adulterated or Commercial n/a 801 (e) (1) Yes No –

(includin MisbrandedBUT does
g not require approval See part V
Biologic under section 505 of A and B
al the Act or licensing
Product) under section 351 of
the PHSA
Insulin Adulterated or Commercial n/a 802 (i) and Yes No –

or Misbranded 801 (e) (1)
Antibioti (irrespective of status
c Drug under section 505 of See part V
the Act or section 351 A and B
of the PHSA
Biologic Partially processed To be n/a section Yes No –

al biological product exported for 351(h) of
Product under section 351 of further the PHSA
the PHSA manufacture
outside the See part V
U.S. A, B, and E
Device Adulterated or Either n/a 801 (e) (1) Yes No –

MisbrandedBUT compl
ies with any applicable See part V
requirement of A, B, and D
sections 514 and 515
of the Act, is not
exempt from sections
514 or 515 of the Act
by section 520(g) of
the Act, and is not a
banned device under
section 516 of the Act
Device Does not comply with Commercial Yes 802 (b) (1) Yes Yes –
an applicable
requirement of See part
sections 514 or 515 of VII C and D
the Act, is exempt
from section 514 or
515 of the Act by
section 520(g) of the
Act, or is a banned
device under section
516 of the Act
Device Does not comply with Investigationa n/a 802 (c) Yes Yes, A party may
an applicable l except instead
requirement of See part for conduct the
sections 514 or 515 of VIII C notificatio export and
the Act, is exempt n under investigation
from section 514 or (g) pursuant to
515 of the Act by the
section 520(g) of the requirements
Act, or is a banned of 21 CFR
device under section Part 812
516 of the Act
Yes 802 (b) (1) Yes Yes

See parts
VII C and
D, VIII C
Device Does not comply with Commercial, No, but 802 (d) Yes Yes, –
an applicable but exported exported in except
requirement of to a listed anticipation See part IX for
sections 514 or 515 of country for of market notificatio
the Act, is exempt further authorizatio n under
from section 514 or formulation, n (g)
515 of the Act by or processing,
section 520(g) of the etc.
Act, or is a banned
516 of the Act
Device Does not comply with Either n/a 801 (e) (2) Yes No Must submit
an applicable request to
requirement of See part V FDA
sections 514 or 515 of D
the Act, is exempt
from section 514 or
515 of the Act by
section 520(g) of the
Act, or is a banned
516 of the Act
Device Does not comply with Intended for No 802(e) is Yes Yes, Requires
an applicable use in a an option except approval of
requirements of tropical for an for an
sections 514 or 515 of disease or export to notificatio application to
the Act, is exempt other disease an unlisted n under FDA before
from section 514 or not of country if (g) the export
515 of the Act by significant the product can begin
section 520(g) of the prevalence in does not
Act, or is a banned the U.S. qualify for
device under section export
516 of the Act under any
other
provision in
section 802
of the Act
See part X
Animal Adulterated or Either n/a 801 (e) (1) Yes No If requires

Drug or Misbranded approval
Feed See part V under section
A and B 512 of the
Act and is
banned in the
United
States,
section 801
(e) (3) of the
Act prohibits
export
Food or Adulterated or n/a n/a 801 (e) (1) Yes No –

Cosmeti Misbranded
c See part V
A and B
Drug, In full compliance with Commercial n/a No specific No No –

Device, the applicable Act or export
Biologic PHSA requirements requiremen
al for distribution and ts
Product, sale in the United
Animal States
Drug or
Feed,
Food,
Cosmeti
c
IV. Statutory Background

Some background information on the statutory requirements that existed before the enactment of the 1996 Amendments
is helpful to understand why the 1996 Amendments were enacted.
A. Historical Background - Exports of Drugs and Biological
Products That May Not be Sold in the United States
The Act’s export provision originated in 1906 as part of the Federal Food and Drugs Act (Public Law 59-384). Section 2 of
the 1906 Federal Food and Drugs Act stated that:
* * * no article shall be deemed misbranded or adulterated within the provisions of this act when intended for export to any
foreign country and prepared or packed according to the specifications or directions of the foreign purchaser when no
substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article
is intended to be shipped; but if said article shall be in fact sold or offered for sale for domestic use or consumption, then
this proviso shall not exempt said article from the operation of any of the other provisions of this act.
This export provision was included, with some modifications, in the Federal Food, Drug, and Cosmetic Act of 1938 (Public
Law 75-717) where it was codified as section 801(d). Section 801(d) of the 1938 Act stated that:
A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act
if it (1) accords to the specifications of the foreign purchaser, (2) is not in conflict with the laws of the country to which it is
intended for export, (3) is labeled on the outside of the shipping package that it is intended for export, and (4) is not sold
or offered for sale in domestic commerce * * *.
The 1938 act also defined the terms, “drug” and “new drug,” and these definitions led to the conclusion that section 801(d)
of the 1938 Act did not apply to new drugs that did not comply with section 505 of the Act. (See, e.g., United States v. An
Article of Drug, etc * * * Ethionamide-INH, No. 67 C 288 (E.D. N.Y. Aug. 19, 1967);United States v. Yaron Laboratories,
Inc., 365 F.Supp. 917, 919 (N.D. Cal. 1972); Compliance Policy Guide 7132c.01 (Oct. 1, 1980).) As a result, the Act was
interpreted as permitting the export of approved drugs, but not permitting the export of unapproved new drugs. This
interpretation was viewed as imposing hardships on the pharmaceutical industry (by impairing its ability to compete in
international markets) without any accompanying public health benefits (see S. Rept. 99-225, 99th Cong., 2d sess. 5-6
(1985)).
To remedy the situation, Congress enacted the Drug Export Amendments Act of 1986 (Public Law 99-660). For human
drug products and biological products, the 1986 Amendments created section 802 of the Act and established three
separate “tracks” for exporting unapproved drugs and unlicensed biological products. Under “track 1,” FDA was
authorized to approve an application for the export of new human and animal drugs and biological products that were not
approved in the United States, so long as the drug contained the same active ingredient(s) as a product for which
marketing approval in the United States was being sought or the biological product was one for which licensing was
actively being pursued. Exports under “track 1" were confined to 21 specific countries listed in section 802 of the Act.
Those countries were: Australia, Austria, Belgium, Canada, Denmark, the Federal Republic of Germany, Finland, France,
Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden,
Switzerland, and the United Kingdom.
Under “track 2,” FDA was authorized to approve the export of drugs and biological products intended for the treatment of
tropical diseases. Persons seeking to export a drug under track 2 had to submit an application to FDA, and FDA had to
find, based on “credible scientific evidence,” that the drug would be safe and effective in the country to which it would be
exported in the prevention or treatment of a tropical disease in that country.
“Track 3" applied to partially processed biological products and amended section 351 of the PHS Act. FDA was
authorized to approve the export of partially processed human biological products intended for further manufacture in any
of the 21 listed countries, but the final product had to be approved or in the process of receiving approval from the foreign
country.
Additionally, the 1986 Amendments added a new section 801(d) of the Act (regarding importation of drugs), and
renumbered the existing section 801(d) as a new section 801(e)(1) of the Act.3
The 1986 Amendments, however, presented several problems and concerns. One significant problem was that the 1986
Amendments limited exports of most unapproved drugs and biological products to 21 countries. Although the 1986
Amendments provided criteria for adding more countries to the list, it omitted any administrative mechanism for doing so.
Consequently, exports of unapproved drugs and biological products to countries that were not on the list were not
permitted.
The requirement that the drug contain the same active ingredient as a drug for which marketing approval in the United
States was being “actively pursued” also caused some concern in the industry. Questions arose concerning the degree to
which the active ingredient had to be the “same” or how “actively” the manufacturer had to be seeking approval.
The requirements in the 1986 Amendments for FDA approval before a product could be exported generated criticism and
debate as well. The 1986 Amendments required a person to file an application to export a drug at least 90 days before the
date on which the applicant proposed to export the drug, and required FDA to publish a notice in the Federal
Register identifying the applicant, the drug to be exported, and the country to which the drug was being exported (for
Track 1 exports only). The 1986 Amendments also established requirements for the application as well as the agency's
action on an application. For example, if the agency decided to disapprove an application, it had to provide a written
statement to the applicant describing deficiencies that the applicant must correct and give the applicant 60 days to correct
those deficiencies. Some firms charged that this approval process took too long; others questioned why the United States
should have to approve the export of a product to a foreign country, particularly when the foreign country had its own
public health authorities or had approved the product for marketing.
B. Historical Background - Exports of Animal Drugs That May
Not Be Sold in the United States
As stated earlier, section 801(e) of the Act was construed as not applying to the exportation of unapproved new human
drugs. This interpretation also covered unapproved new animal drugs, and was made explicit in 1968 as part of the
Animal Drug Amendments of 1968 (Public Law 90-399). Although the initial Congressional bill would have permitted
exportation of unapproved new animal drugs, Congress, at the request of the then-Department of Health, Education, and
Welfare, elected to amend section 801 of the Act to prevent the exportation of unapproved new animal drugs and animal
feed containing unapproved new animal drugs (see S. Rept. 1308, 90th Cong., 2d Sess., 1968 U.S. Code Cong. & Admin.
News 2160). The legislative history explained that the amendment’s purpose was to “preserve, essentially, the status quo
with respect to the export exemption” (id.).
The Drug Export Amendments Act of 1986 altered the export requirements for unapproved new animal drugs in the same
manner that it changed the export requirements for unapproved new human drugs (such as limiting exports to 21 specific
countries and requiring the exporter to be pursuing product approval in the United States as a condition for allowing
exportation). Consequently, under the 1986 amendments, an unapproved new animal drug could be exported under
section 802 of the Act.
C. Historical Background - Exports of Devices That May Not

Be Sold in the United States
As stated earlier, then-section 801(d) of the Federal Food, Drug, and Cosmetic Act of 1938 (now codified at section
801(e) of the Act) stated that a food, drug, device, or cosmetic intended for export would not be considered adulterated or
misbranded if the product: (1) Met the foreign purchaser’s specifications; (2) was not in conflict with the laws of the
country to which it was being exported; (3) was labeled on the outside of the shipping package that the product was
intended for export; and (4) was not sold or offered for sale in domestic commerce.
This authority remained unchanged until 1976 when, as part of the Medical Device Amendments Act of 1976 (Public Law
94-295), Congress amended the provision to state that the four criteria did not apply to any device that did not comply with
an applicable requirement under sections 514 (performance standards) or 515 (premarket approval) of the Act, to devices
that were exempt from sections 514 or 515 of the Act under section 520(g) of the Act (devices subject to an IDE), and to
banned devices (under section 516 of the Act) unless, in addition to requiring compliance with section 801(e)(1) of the Act,
the agency determined that exportation of the device would not be contrary to the public health and safety and the device
had the approval of the foreign country that would receive the device. In other words, most unapproved devices could not
be exported unless the agency determined that exportation would not be contrary to the public health or safety and that
the foreign country approved of the device. This provision was, and remains, codified at section 801(e)(2) of the Act (21
U.S.C. 381(e)(2)).
As in the case of FDA drug export approvals, the statutory requirement that FDA approve device exports led to criticism
from the device industry. The device industry criticized the agency for the amount of time FDA took to determine whether
an export request met the statutory criteria. FDA reduced the time for processing device export requests from an average
of 91 days in 1992 to 10 days in 1995. Despite this significant reduction in processing time, the statute’s export approval
requirements were seen as adversely affecting the ability of U.S. firms to enter or to compete in foreign markets.
D. Enactment of the FDA Export Reform and Enhancement

Act of 1996
The FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, and amended by Public Law 104-180)
addressed the industries’ chief problems and concerns. For human drugs and biological products that may not be sold in
the United States, the 1996 Amendments:
 Amended section 801 of the Act to allow exports of approved drugs (except for insulin and antibiotics) to
countries that have different or additional labeling requirements or conditions for use. The new provision, at section
801(f) of the Act, requires such drugs to be labeled in accordance with the requirements and conditions for use in the
foreign country and also to be labeled in accordance with the Act. If the drug’s labeling includes conditions for use that
are not approved in the United States, the labeling must state that such conditions for use have not been approved
under the Act.
 Replaced section 802 of the Act in its entirety with a new section 802 of the Act that:
o Eliminated the requirement for prior FDA approval of exports of unapproved drugs in most cases,
 Significantly expanded the list of countries to which unapproved products can be exported without prior FDA
approval (and also provided administrative mechanisms for the Secretary of Health and Human Services (the
Secretary) to add countries to the list and for FDA to permit exports of specific products to unlisted countries),
 Authorized exports of unapproved drugs and biological products intended for use in clinical investigations in any
of the listed countries,
 Authorized the export of certain unapproved products to a listed country in anticipation of marketing approval in
that country,
 Created a simple notification process for most exported products (as opposed to the application process
required under the 1986 Amendments). Notification is not required for drugs exported for investigational use in a listed
country or drugs exported to a listed country in anticipation of marketing authorization, and
 Authorized FDA to permit the export of unapproved products intended to treat tropical or other diseases that are
“not of significant prevalence in the United States.”
For animal drugs that may not be sold in the United States, the 1996 Amendments:
 Restricted the authority to export an unapproved new animal drug to section 801(e)(1) of the Act. Animal drugs
cannot be exported under section 802 of the Act because that section pertains to biological products, devices,
and human drugs.
 The only unapproved new animal drugs that cannot be exported under section 801 of the Act are animal drugs
that have been “banned in the United States” (see section 801(e)(3) of the Act).
For devices that may not be sold in the United States, the 1996 Amendments:
 Amended section 801 of the Act to permit exportation of certain devices under section 801(e) of the Act orunder
section 802 of the Act;
 Replaced section 802 of the Act in its entirety with a new section 802 of the Act that:
o Eliminated the requirement for prior FDA approval for exports (for devices approved in a listed
country or destined for clinical investigations in a listed country),
 Created administrative mechanisms for the Secretary to add countries to the list and for FDA to approve exports
of specific products to unlisted countries,
 Authorized exports of unapproved devices intended for use in clinical investigations in any of the countries
identified in section 802 of the Act,
 Authorized the export of unapproved devices to a listed country in anticipation of marketing approval in that
country,
 Created a simple notification process for exported devices (as opposed to the application process under section
801(e)(2) of the Act). Notification is not required for devices exported for investigational use to a listed country or
devices exported to a listed country in anticipation of marketing authorization in the listed country; and
 Authorized FDA to permit the export of unapproved devices intended to treat tropical diseases or other diseases
that are “not of significant prevalence in the United States.”
This document describes the requirements for drugs (both human and animal), biological products, and devices under
sections 801 and 802 of the Act and section 351(h) of the PHS Act, as amended by the 1996 Amendments. The general
requirements under section 801(e)(1) of the Act also apply to exports of foods, cosmetics, antibiotics, and insulin that do
not comply with the Act's requirements for sale and distribution in the United States. (The Act treats exports of antibiotics
and insulin differently from other human drugs (see part VI of this guidance document).)

V. General Requirements for Products Exported

Under Section 801(e)(1) of the Act
A. Summary of Section 801(e)(1) of the Act

Section 801(e)(1) of the Act contains general export requirements for any food, drug, device, or cosmetic that is
adulterated or misbranded under the Act. These requirements also apply to products exported in accordance with
sections 801(e)(2), 801(f), or 802 of the Act or section 351(h) of the PHS Act.4 Depending on the type of product being
exported and the legal authority supporting the product’s exportation, requirements in addition to those in section 801(e)
(1) of the Act may apply. The 1996 Amendments made no changes to section 801(e)(1) of the Act.
Section 801(e)(1) of the Act states that a food, drug, device, or cosmetic intended for export shall not be deemed to be
adulterated or misbranded if the article:
 Accords to the specifications of the foreign purchaser;
 Is not in conflict with the laws of the country to which it is intended for export;
 Is labeled on the outside of the shipping package that it is intended for export; and
 Is not sold or offered for sale in domestic commerce.
As a statutory exemption, this provision is to be construed narrowly. The party seeking to export the product bears the
burden of demonstrating that the criteria of the exemption are met.
B. Determining Compliance with Section 801(e)(1) of the Act

During routine inspections, FDA will evaluate whether a firm has complied with section 801(e)(1) of the Act. Consequently,
records are very important for demonstrating compliance with each element of section 801(e)(1) of the Act. FDA’s record
keeping requirements that implement section 801(e)(1) of the Act can be found at 21 CFR § 1.101(b).
1. Meeting a Foreign Purchaser’s Specifications
To demonstrate that the product meets the foreign purchaser’s specifications, the firm exporting the product must
maintain records which contain sufficient information to match the foreign purchaser’s specifications to a particular export
(see 21 CFR § 1.101(b)(1)). This could include details about the product (e.g., dosage strength, dosage form, purity,
quality, operating parameters, composition, etc.) and any details concerning the product’s manufacture (e.g., type of
sterilization process to be used, compliance with a particular manufacturing standard, etc.) as requested by the foreign
purchaser. For example, if the article is food with a food additive that is not approved in the United States, this could
include records showing that the purchaser requested that the food contain the particular food additive. A second example
would be records showing that the purchaser specifically requested the inclusion or exclusion of a particular
manufacturing step, where the article is violative under U.S. cGMP's due to the presence or absence of that
manufacturing step. A third example is where the foreign purchaser does not request a particular manufacturing step but
instead requests that the product be manufactured pursuant to a set of specific manufacturing standards that are
inconsistent with, or at least different from, U.S. cGMP's. In this example, sufficient records could include records showing
that the purchaser requested that the product be manufactured pursuant to this set of manufacturing standards and that
the manufacturing process met the specified standards. A fourth example is where the foreign purchaser places an order
for a product but does not provide any specifications (e.g., that a particular food additive, manufacturing step, or
manufacturing standard be used). In such a case, the foreign purchaser's order, standing alone, would not be sufficient to
satisfy section 801(e)(1)(A) of the Act.
In addition, if the foreign purchaser sought 5,000 bottles of drug X tablets, with each tablet at a 50 mg. dose, FDA would
look for records to show that a particular shipment of drug X to the foreign purchaser consisted of 5,000 bottles of drug X
in a 50 mg. tablet form. As noted in the preamble to the final rule (66 FR 65429 (December 19, 2001)), records stating
only that drug X was shipped to the foreign purchaser would not be satisfactory because the records would not reflect
whether the purchaser sought a particular dosage or quantity and would not show whether the export met that dosage
specification or whether the quantity that was exported met the purchaser’s specification.
FDA does not expect complete specifications to accompany every order of the same product. For example, if an exporter
signs a contract to ship the same item to a foreign purchaser on a monthly basis, the agency would not expect the
exporter to obtain complete specifications for each monthly shipment. However, FDA would expect the exporter to have
specifications that applied to the initial shipment and records showing that subsequent shipments correspond to the same
initial specifications. The agency’s principal interest is to link records to specific export shipments to verify that a particular
exported product met the foreign purchaser’s specifications. The level of detail in the specifications may vary between
orders, but § 1.101(b)(1) requires exporters to maintain records that demonstrate that the exported product met the
foreign purchaser’s specifications.
FDA recommends that the firm have an English-language translation of the specifications document or be prepared to
translate the document into English at the time of any FDA inspection.
2. Not in Conflict with the Laws of the Importing Country
Under 21 CFR § 1.101(b)(2), there are two possible ways for demonstrating that the product to be exported does not
conflict with the laws of the importing country. The regulation states that records demonstrating that the product does not
conflict with the laws of the importing country may consist of either:
 a letter from an appropriate foreign government agency, department, or other authorized body stating that the
product has marketing approval from the foreign government or does not conflict with that country’s laws, or
 a notarized certification by a responsible company official in the United States that the product does not conflict
with the laws of the importing country. If a certification is used, the certification must be in English and include a
statement acknowledging that the person making the certification is subject to the provisions of Title 18, section 1001
of the United States Code.5
On July 22, 2002, FDA stated, in response to a petition for reconsideration, that it will generally not take enforcement
action regarding § 1.101(b)(2) while the agency considers whether any changes are necessary to the regulatory provision
as to how a company can demonstrate that the product to be exported does not conflict with the laws of the importing
country. FDA's July 22, 2002, letter also stated "we reiterate that affected parties must continue to comply with the
statutory requirements for exports under sections 801(e) and 802 of the Act." On June 1, 2004, FDA published an
advance notice of proposed rulemaking seeking comments on this issue (69 FR 30842).
3. Shipping Package Labeling Showing That the Product Is Intended for Export
To demonstrate that the product is labeled on the outside of the shipping package that it is intended for export, § 1.101(b)
(3) requires records that show such labeling or labeling statements. These records may consist of copies of labels or
labeling statements, such as “For export only,” that are placed on shipping packages or, if the exported product lacks a
shipping package or container, on shipping invoices or other documents accompanying the exported product.
4. Product Is Not Sold or Offered for Sale in the United States
To demonstrate that the product is not sold or offered for sale in the United States, § 1.101(b)(4) indicates that production
and shipping records for the exported product and promotional materials may be sufficient.
For example, in situations where there are multiple batches of the same product, batches of a product that are intended
for export throughout the manufacturing process or produced on manufacturing lines that are dedicated to export
markets may meet the requirement in section 801(e)(1)(D) of the Act. Even in these situations, however, if a firm is selling
the same product both in the United States and overseas and the product for sale in the United States is adulterated or
misbranded in the same way as the product intended for export, then the agency would consider the product to be sold or
offered for sale in domestic commerce. Another situation is where a firm does not decide to export a specific product until
it has already begun the manufacturing process, for example to meet an overseas inventory need. This also may meet the
section 801(e)(1)(D) requirement if the decision to export the product is made at a distinct, identifiable, and documented
point in the manufacturing process; the product is not adulterated or misbranded at the point the decision is made; and the
action that causes the product to become adulterated or misbranded, such as conforming the product to a foreign
specification, is taken subsequent to the decision. In each of these situations, the product intended for export should be
clearly identifiable and segregable from product intended for the U.S. market.
If the product's sale in the United States does not violate the Act, and the same product is intended for export for the
same approved use and is accompanied closely by the FDA-approved labeling (if FDA labeling approval is required), FDA
may consider the product to be sold or offered for sale in the United States. Nonetheless, under these circumstances,
FDA would consider the product to be in compliance with the Act such that it would not have to meet the criteria of section
801(e)(1) of the Act to be exported. By stating that the product is “accompanied closely” by the FDA-approved label (if
FDA is required to approve the product’s labeling), FDA does not expect the FDA-approved label be affixed to each
exported product, but the agency does expect the FDA-approved label to be included in the export shipment. The agency
recognizes that no interest would be served by requiring firms to attach FDA-approved labels to exported products
otherwise in compliance with the Act’s requirements for sale and distribution in the United States if those labels would
have to be removed or altered for the product to be sold in a foreign country. In contrast, if the product to be exported:
 involves a use that is not approved in the United States, or
 is labeled solely in a foreign language and that foreign language labeling discusses uses that have not been
approved by FDA,
then the product is “unapproved” and falls within the Act’s export provisions. In these cases, FDA would not consider the
product with the foreign language label to be sold or offered for sale in the United States within the meaning of section
801(e)(1)(D) of the Act unless this version of the product, with the foreign language label, was sold or offered for sale in
the United States.
To summarize, the requirements in section 801(e)(1) of the Act apply to foods, drugs (both human and animal (except for
“banned” animal drugs, which may not be exported)), biological products, devices, and cosmetics intended for export,
whether they are exported under section 801 or section 802 of the Act or section 351(h) of the PHS Act. Furthermore,
depending on the type of product being exported and the legal authority supporting the product’s exportation, additional
requirements may apply.
C. Special Restrictions on Animal Drugs

The 1996 Amendments excluded certain animal drugs from exportation. Section 801(e)(3) of the Act states that animal
drugs that have been “banned in the United States” may not be exported. Neither the 1996 Amendments nor the
legislative history explains what constitutes a “banned” animal drug.
D. Special Requirements for Certain Devices

Some devices have additional statutory requirements before they can be exported under section 801(e)(1) of the Act.
Under section 801(e)(2) of the Act, if a device:
 Does not comply with an applicable requirement under sections 514 (performance standards) or 515 (premarket
approval) of the Act,
 is exempt from either such section under section 520(g) of the Act, or
 is a banned device under section 516 of the Act,
the device may not be exported unless, in addition to the requirements in section 801(e)(1) of the Act, FDA has
determined that device’s exportation is not contrary to the public health and safety and has the approval of the country to
which it is intended for export, or the device is eligible for export under section 802 of the Act.
The Act provides that any device introduced into interstate commerce after May 28, 1976, is automatically considered to
be a “class III” device requiring premarket approval under section 515 of the Act. Such devices may not be legally
marketed unless and until FDA: (1) Classifies the device into class I or II; (2) grants marketing clearance by issuing an
order under section 513(i) of the Act, in response to a report submitted by the sponsor under section 510(k) of the Act,
determining that the device is substantially equivalent to a predicate device that does not require premarket approval
(hereinafter referred to as 510(k) marketing clearance); or (3) issues an order under section 515(d)(1)(A) of the Act
approving an application for premarket approval.
The Act prohibits exportation of class III devices requiring premarket approval unless the criteria under section 801(e)(2)
of the Act are met (or the device qualifies for export under section 802 of the Act). FDA has exercised its enforcement
discretion and, to date, has not taken enforcement action against a firm who has not complied with the export criteria in
section 801(e)(2) of the Act, provided that the firm has reasonably concluded that FDA would have granted 510(k)
marketing clearance if a report under section 510(k) of the Act had been submitted. FDA intends, on a case by case
basis, to continue to consider the exercise of its enforcement discretion in this manner with respect to the requirements in
section 801(e)(2) of the Act. FDA emphasizes, however, even if a firm reasonably believes that its device would receive a
510(k) marketing clearance, FDA does not intend to consider the exercise of its enforcement discretion in this manner
with respect to the requirements in section 801(e)(1) of the Act.
To help FDA determine whether exportation of the device is not contrary to the public health and safety, FDA
recommends that firms provide basic safety data for the device. Such data often consists of a statement certifying that a
search of medical databases has not identified any adverse safety data for similar devices or the materials used in the
device, or summaries of any adverse safety data, including a discussion as to why the adverse effects should not be
considered applicable to the device that is to be exported. Brief summaries of available animal safety studies conducted
with the device and safety data from human clinical studies are also helpful. For in vitro diagnostic devices, where the
device is to be the sole determinate of whether a particular course of treatment will be initiated for a life-threatening
disease, the agency recommends that the firm provide a statement indicating whether an alternative test will be available
to confirm the test results. FDA ordinarily does not need safety data if the device is the subject of an approved IDE or is
considered to have an approved IDE, and will be marketed or used in the importing country for the same intended use. 6
To help FDA determine whether exportation of the device has the approval of the country to which it is intended for export,
FDA recommends that the firm obtain a letter from the foreign country authorizing the device’s importation. If the firm is
exporting the device to a country in the European Economic Area and the device has received a CE mark, documentation
of the CE mark will ordinarily be sufficient.
Additional information regarding device exports under section 801(e)(2) of the Act can be found in the guidance document
entitled, “Procedures for Obtaining FDA Approval to Export Unapproved Medical Devices.” (To obtain copies of this
guidance, see “For Further Information Contact” in part XII of this document.)
E. Special Requirements for Partially Processed Biological

Products
The 1996 Amendments also changed the export requirements for partially processed biological products. Under section
351(h) of the PHS Act, a partially processed biological product may be exported if it is:
 “Not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man,”
 not intended for sale in the United States, and
 intended for further manufacture into final dosage forms outside the United States.
Exports of such products must comply with section 801(e)(1) of the Act and with cGMP’s or international manufacturing
standards as certified by an international standards organization recognized by the agency.
1. What Constitutes a Partially Processed Biological Product?
FDA interprets the term “partially processed biological products” as meaning biological products requiring purification,
inactivation, fractionation, or significant chemical modification (such as the formation or breakage of covalent bonds and
the incorporation of peptides into a diagnostic test kit) before being used in the formulation of a final product. Thus, a
finished bulk product that could be formulated into a finished dosage form through manufacturing steps other than
purification, inactivation, fractionation, or significant chemical modification would not constitute a partially processed
biological product that could be exported under section 351(h) of the PHS Act. Certain other products, such as source
plasma and source leukocytes, also would not be partially processed biological products because they are finished
products (notwithstanding the possibility that their intended use may be as a source material for further manufacturing into
another product), and would be subject to licensure if distributed in the United States. Note that unlicensed biological
products that do not qualify for export under section 351(h) of the PHS Act may qualify for export under section 802 of the
Act.
Products that do qualify as partially processed biological products include intermediate biological products that a firm has
partially processed and that would be subject to licensure as final products after the completion of additional
manufacturing steps. FDA encourages persons who may be uncertain as to whether their products are partially processed
biological products to contact the Center for Biologics Evaluation and Research (see the “For Further Information Contact”
in part XII of this document for the address and phone number).
2. cGMP Requirements
Section 351(h) of the PHS Act also requires partially processed biological products to be “manufactured, processed,
packaged, and held in conformity with current good manufacturing practice requirements” or meet international
manufacturing standards recognized by the agency. FDA inspects firms to ensure that they are in compliance with
cGMP’s.
Section 351(h) of the PHS Act refers to “international manufacturing standards as certified by an international standards
organization” recognized by FDA. As of August, 2006, FDA has not recognized any such international standards
organizations for purposes of section 351(h) of the PHS Act.
3. Additional Requirements Under Section 351(h) of the PHS Act
All exports of FDA-regulated products that may not be sold or marketed in the United States, including partially processed
biological products exported under section 351(h) of the PHS Act, must conform to the standard export requirements of
section 801(e)(1) of the Act. Thus, a product intended for export under section 351(h) of the PHS Act must:
 Accord with specifications of the foreign purchaser;
 not be in conflict with the laws of the country to which it is intended for export;
 be labeled on the outside of the shipping package that it is intended for export; and
 not be sold or offered for sale in domestic commerce.
Consistent with section 801(e)(1) of the Act, section 351(h)(2) of the PHS Act further requires that the product may not be
intended for sale in the United States.
Records are important in FDA’s evaluation of compliance with section 351(h) of the PHS Act, including the requirements
section 801(e)(1) of the Act. FDA regulations, at 21 CFR 1.101(c), require persons exporting a partially processed
biological product under section 351(h) of the PHS Act to meet the recordkeeping requirements in § 1.101(b) (discussed
in part V.B above) and to maintain the following records:
 Records demonstrating that the product for export qualifies as a partially processed biological product and not
in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
 Records demonstrating that the partially processed biological product was manufactured in accordance with
cGMP’s;
 Records demonstrating the distribution of the exported, partially processed biological products;
 Copies of all labeling that accompanies the exported, partially processed biological product; and
 Other records demonstrating that the product is intended for further manufacture into a final dosage form
outside the United States. This may include a container label with the statement, “Caution: For Further Manufacturing
Use Only” and any package insert.
Additionally, firms that manufacture, prepare, or process partially processed biological products for export must register
with FDA and list their products under section 510 of the Act and 21 CFR parts 207, 607, or 807, whichever is applicable.

VI. Labeling Requirements for Drugs and Biological

Products Exported Under Section 801(e)(1) of the Act -
Section 801(f) of the Act

The 1996 Amendments contained a new provision that permits the export of drugs (other than insulin, antibiotics, animal
drugs, or drugs exported under section 802 of the Act)7 that may be sold in the United States and are being exported to a
country that has different or additional labeling requirements or conditions for use (compared to those on the FDA-
approved labeling), and the foreign country requires the drug to be labeled in accordance with those requirements or
uses. For these drugs, section 801(f) of the Act imposes certain labeling requirements. Under section 801(f)(1) of the Act,
the drug intended for export may be labeled in accordance with the foreign requirements and conditions for use as long
as the drug is also labeled in accordance with the Act.
If the labeling includes conditions of use that are not approved in the United States, section 801(f)(2) of the Act requires
the labeling to state that those uses are not approved under the Act. The Act defines “labeling” as “all labels and other
written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such
article.” Thus, to comply with section 801(f)(2) of the Act, FDA suggests that a firm place a statement on the labeling
regarding the uses that are not approved in the United States wherever an unapproved use appears. For example, if an
unapproved use is on the immediate label and on the product’s container, a statement identifying the uses that are not
approved in the United States would appear on the immediate label and on the product’s container.
FDA has received questions regarding whether the statement identifying the uses that are not approved in the United
States should be in the language used in the foreign country. Although section 801(f) of the Act is silent on this point, the
agency suggests that the statement be in the language used in the foreign country (i.e., the language of the foreign use
labeling as a whole) because the statutory requirement is more meaningful if foreign consumers can read the statement.
In some instances, products that may be exported in compliance with the labeling requirements in section 801(f) of the Act
may also qualify for export under section 802(b)(1)(A) of the Act (discussed in part VII.D of this document). In such cases,
a firm may elect to export a product under either section 801(e) or section 802(b) of the Act so long as the product meets
the statutory requirements for export. A drug exported under section 802 of the Act is not subject to the labeling
requirements in section 801(f) of the Act.

VII. Exports of Unapproved Drugs, Biological Products,

and Devices Under Section 802(b) of the Act

A. Drugs and Biological Products

As stated earlier, courts and FDA have interpreted section 801(e) of the Act as being inapplicable to unapproved new
drugs and biological products. As a result, the 1986 Amendments amended the Act so that the export of unapproved new
drugs and biological products was regulated under section 802 of the Act.
The 1996 Amendments, insofar as human drugs and biological products are concerned, modified the scope of section
802 of the Act to state that the provision applies to drugs and biological products that:
 Require approval under section 505 of the Act or, for biological products, require licensing under section 351 of
the PHS Act;
 do not have such approval or license; and
 are not exempt from section 505 of the Act or section 351 of the PHS Act.
Thus, section 802 of the Act applies to unapproved new human drugs and biological products and to approved human
drugs and biological products being exported for unapproved uses.8 This includes a drug required to have approval under
section 505 of the Act and lacking such approval, a drug that does not comply with its conditions of approval, and a drug
that does not comply with an applicable over-the-counter drug monograph. If FDA disapproves an application for a drug or
biological product, and that product has been or will be exported to one or more foreign countries, section 802(a) of the
Act requires FDA to notify the appropriate foreign public health official in those countries of its decision.
Section 802 of the Act also contains special provisions for drugs and biological products intended for investigational use in
a listed country, drugs and biological products intended for further processing or labeling to fill the pipeline in anticipation
of marketing authorization in a listed country, and drugs and biological products intended to treat a tropical disease or
disease that is “not of significant prevalence in the United States.” These provisions are discussed in parts VIII through X
of this document.
B. Devices
Section 802(b) of the Act, like section 801(e)(2) of the Act, applies to devices that:
 Do not comply with an applicable requirement under section 514 or 515 of the Act;
 are subject to an IDE; or
 are banned devices.
This means that devices that have premarket approval are not subject to section 802 of the Act, nor are devices that are
the subject of a marketing clearance under the premarket notification provision under section 510(k) of the Act. As is the
case for disapproved drugs and biological products, if FDA disapproves an application for premarket approval under
section 515 of the Act, and the device has been or will be exported to one or more foreign countries, section 802(a) of the
Act requires FDA to notify the appropriate foreign public health official in those countries of its decision.
Section 802’s provisions for products intended for investigational use in a listed country, intended for further processing or
labeling to fill the pipeline in anticipation of marketing authorization in a listed country, or intended to treat a tropical
disease or disease that is “not of significant prevalence in the United States” also apply to devices.
C. Basic Requirements for All Products Exported Under

Section 802 of the Act
Section 802(f) of the Act imposes certain basic requirements for all drugs, biological products, and devices exported under
section 802 of the Act. In brief, these requirements are as follows:
 The product must be manufactured, processed, packaged, and held in “substantial conformity” with cGMP’s or
meet international standards as certified by an international standards organization recognized by FDA. Neither the
1996 Amendments nor its legislative history explains what constitutes “substantial conformity” with cGMP’s, but the
legislative history for the Generic Drug Enforcement Act of 1992 may be instructive. In discussing the terms
“substantial compliance” with cGMP’s and good laboratory practices, the House Committee on Energy and Commerce
suggested that “substantial compliance” could not mean fullcompliance with GMPs because FDA “lacks the continuing
presence that would be necessary to conclude that a firm is in full compliance with GMPs and GLPs” (see H. Rept.
102-272, 102d Cong., 2d sess. 20 (1992)). FDA interprets the term “substantial conformity” under section 802(f)(1) of
the Act in a similar manner. The term does mean that the firm should have passed its most recent GMP inspection (or
that GMP violations have been rectified, and the firm has credible systems and personnel in place to prevent a
recurrence of the violation(s)). The agency has not recognized an international standards organization for purposes of
section 802(f) of the Act, but is examining this issue closely.
 The product must not consist in whole or in part of any filthy, putrid, or decomposed substance and must not
have been prepared, packed or held under insanitary conditions where it may have been contaminated with filth or
whereby it may have been rendered injurious to health;
 The container for the product must not be composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health;
 The product must have the strength, purity, and quality that it purports or is represented to possess;
 For drugs, no substance may be mixed or packed with the drug that would reduce the drug’s quality or strength
or may substitute in whole or in part for another substance in the drug;
 The product must comply with the requirements in section 801(e)(1) of the Act. (A discussion of the
requirements in section 801(e)(1) of the Act appears in part V.B of this guidance document. FDA regulations, at 21
CFR 1.101(b), describe the records that a person must retain to demonstrate compliance with section 801(e)(1) of the
Act.)
 The product cannot be the subject of a notice by FDA or the U.S. Department of Agriculture determining that the
probability of reimportation of the exported product would present an imminent hazard to the public health and safety of
the United States, such that exportation must be prohibited;
 The product cannot present an imminent hazard to the public health of the country to which it would be
exported; and
 The product must be labeled in accordance with the requirements and conditions of use in the listed country
(see part VII.D., below) in which it received valid marketing authorization, if applicable, and the country to which it
would be exported, and must be labeled in the language and units of measurement used in or designated by the
country to which the drug or device would be exported. Additionally, a product may not be exported if it is not promoted
in accordance with these labeling requirements.
If the above requirements are not met, section 802(f) of the Act states that the drug or device may not be exported under
section 802 of the Act. Furthermore, in determining whether a drug or device may present an imminent hazard to the
public health of the foreign country or is improperly labeled or promoted, section 802(f) of the Act requires FDA to consult
with the “appropriate public health official in the affected country.”
Exporters are responsible for determining whether export is permitted under the Act and whether their exports meet the
requirements in section 802(f) of the Act. During an inspection, FDA will evaluate compliance with the relevant export
provisions as appropriate. As discussed below, section 802(g) of the Act requires persons exporting drugs and devices
under section 802(b)(1) of the Act to maintain records of such exported products and the countries to which they were
exported and to provide a simple notification to the agency regarding such exports. FDA’s export notification requirements
can be found at 21 CFR 1.101(d).
D. Exports of Unapproved New Drugs, Biological Products,

and Devices to a Listed Country - Section 802(b)(1)(A) of the
Act
The principal provision authorizing the exportation of unapproved new drugs, biological products, and devices is section
802(b)(1)(A) of the Act. Section 802(b)(1)(A) of the Act states that a drug or device “may be exported to any country, if the
drug or device complies with the laws of that country and has valid marketing authorization by the appropriate authority” in
Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, or any member nation in the European Union
or the European Economic Area. As of July, 2007, the EU countries are: Austria, Belgium, Bulgaria, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. The
EEA countries are the EU countries, Iceland, Liechtenstein, and Norway. The number of “listed countries” expands
automatically as countries become members of the EU or the EEA.
This means that a firm whose drug or device has received marketing authorization in any of the countries listed above can
export that drug or device to any country in the world, without submitting an export request to FDA or receiving FDA
approval to export the drug or device, as long as the drug or device meets applicable requirements of the Act, including
the laws of the country to which the product is being exported. This is a change from the 1986 Amendments, under which
firms had to seek prior FDA approval to export under this provision.
FDA interprets the term “valid marketing authorization” as meaning an affirmative decision by the appropriate public health
authority in a foreign country to permit the drug, biological product, or device to be sold in that country. For example,
under this interpretation, if country D approves a drug for investigational use, the approval would not constitute “valid
marketing authorization” because country D’s decision did not extend to commercial marketing. Likewise, a decision by
country D to permit sales to another country would not represent “valid marketing authorization” because it does not
permit sales within country D. Some countries, however, have regulatory systems that permit marketing without an
affirmative act or decision by the government. In such cases, FDA may consider a drug, biological product, or device to
have “valid marketing authorization” if the listed country does not object to the product’s marketing in that country. In these
cases, FDA recommends that the firm obtain a document from the relevant authority in the listed country indicating that it
does not object to the product’s marketing.
As for the word “drug,” the drug to be exported under section 802(b)(1)(A) of the Act should be the same product as the
drug that received marketing authorization in the listed foreign country. Thus, the issue of whether the drug to be exported
must be exactly identical to the drug authorized in the listed country may depend on the conditions surrounding market
authorization in the foreign country. For example, under this interpretation, if country E’s marketing authorization applies
only to a drug product with a specific composition, rather than to drugs that have a particular active ingredient or general
composition, then the drug that is to be exported from the United States should have the same composition as the drug
that received marketing authorization in country E. If, however, country E approves a drug product and, as a result of that
approval, permits marketing of other drugs using the same active ingredient, then the “drug” that could be exported under
section 802(b)(1)(A) of the Act could be any drug that has the same active ingredient.
Similarly, the product’s use can be an issue. If the listed country approved the drug for a specific use, then the exported
drug should be indicated for that specific approved use. For example, under this interpretation, if country E grants market
authorization for a drug only to treat disease X, then a drug exported under section 802(b)(1)(A) of the Act in reliance on
country E’s marketing authorization should be indicated for treatment only of disease X. If, however, the listed country’s
market authorization is not specific to a particular use, then the exported drug can be for any use, provided that such use
remains consistent with the terms of the listed country’s market authorization.
Similar concepts apply to devices. Devices that are exported under section 802(b)(1)(A) of the Act should be similar (to
the degree that any variation could not affect the safety or effectiveness of the product) or identical to the devices that
receive marketing authorization in a listed country, depending on the requirements of that listed country. The uses for the
exported device should also be consistent with the requirements of the listed country.
E. Expanding the List of Countries in Section 802(b)(1)(A) of
the Act
The list of countries in section 802(b)(1)(A) of the Act can expand. The 1996 Amendments contained a mechanism
whereby the Secretary may add other countries to the list, provided that the country meets certain criteria. These criteria
include: (1) Statutory or regulatory requirements which require the review of drugs and devices for safety and
effectiveness by a government entity in that country and which authorizes marketing approval of only those drugs and
devices that trained and qualified experts acting on behalf of the government have determined to be safe and effective, (2)
statutory or regulatory requirements pertaining to cGMPs, (3) statutory or regulatory requirements for reporting adverse
events and for removing unsafe or ineffective drugs and devices from the market, (4) statutory or regulatory requirements
that a product’s labeling and promotion be in accordance with the product’s approval, and (5) equivalence of the country’s
marketing authorization system with that in the listed countries.
Under section 802(b)(1)(B) of the Act, the authority to add countries to the list rests solely in the Secretary of Health and
Human Services. Thus, FDA has no authority to add countries to the list.
F. Exports of Unapproved New Drugs and Biological Products

to an Unlisted Country - Section 802(b)(2) and (b)(3) of the Act
If a firm intends to export an unapproved new drug (including a biological product) to a foreign country not included in
section 802(b)(1)(A) of the Act and the drug does not have valid marketing authorization in a listed country, the firm has
two other options for exporting the product. 9
One option is in section 802(b)(2) of the Act. This section permits a firm to export an unapproved drug directly to an
unlisted country if:
 The drug complies with the laws of the foreign country and has valid marketing authorization by the “responsible
authority” in that country, and
 FDA determines that the foreign country has statutory or regulatory requirements:
o Which require the review of drugs for safety and effectiveness by a government entity in that country
and which authorize marketing approval of drugs which trained and experienced experts have determined to be safe
and effective. The experts must be employed by or acting on behalf of the foreign government entity and base their
determination on adequate and well-controlled investigations (including clinical investigations);
o pertaining to cGMP’s;
o for reporting adverse events and for removing unsafe or ineffective drugs from the market; and
o which require that the labeling and promotion be in accordance with the product’s approval.
FDA recommends that firms intending to export drugs under section 802(b)(2) of the Act provide to the agency
documentation showing that the drug complies with the foreign country’s laws and has valid marketing authorization. (If
the country has a regulatory system that allows marketing without an affirmative decision by the government, FDA
recommends that the firm obtain a document indicating that the authorities in that country do not object to the product’s
marketing.) The agency also suggests that firms provide documentation so FDA can make its determination on the foreign
country’s statutory and/or regulatory requirements. Copies of the foreign country’s laws and regulations (in English) may
be helpful, but are not required; firms may also provide a description of the foreign country’s laws and regulations with
citations that identify the precise law or regulation. If FDA cannot make the necessary determinations concerning the
foreign country’s statutory and regulatory requirements, the firm cannot export the drug under section 802(b)(2) of the Act.
Because section 802(b)(2) of the Act requires FDA to evaluate the foreign country’s statutory and regulatory system, the
agency’s determination concerning the foreign country’s statutory and regulatory requirements may be applicable to
subsequent exports if the foreign country’s statutes or regulations remain unchanged. FDA intends to make decisions
under section 802(b)(2) publicly available, either through a notice in theFederal Register or through some other means.
The second option is in section 802(b)(3) of the Act. This section permits a firm to petition the agency to authorize
exportation to an unlisted country if the conditions for export under section 802(b)(1) and 802(b)(2) of the Act cannot be
met. Under section 802(b)(3) of the Act, FDA shall allow exportation of the drug if:
 The person exporting the drug: (1) Certifies that the drug would not meet the conditions for approval under the
Act or the conditions for approval in a listed country; and (2) provides “credible scientific evidence” for the product to be
exported that is acceptable to FDA to show that the drug would be safe and effective under the conditions of use in the
country to which it is being exported. The statute does not specify what constitutes “credible scientific evidence,” but an
adequate and well-controlled study or studies, animal and in vitro pharmacology and toxicology studies, microbiology
studies (for biological products), and statistical analyses of data should be helpful; and
 the appropriate health authority in the foreign country that is to receive the drug: (1) Requests approval of the
drug’s exportation; (2) certifies that the health authority understands that the drug is not approved under the Act or by
any listed country; and (3) concurs that the scientific evidence provided to FDA is credible scientific evidence that the
drug would be reasonably safe and effective in the foreign country. Please note that the foreign health authority must
“concur” that the evidence provided to FDA is credible scientific evidence regarding the drug’s safety and efficacy; this
means that the foreign health authority should base its concurrence on the same evidence presented to FDA. If the
foreign health authority reviewed different evidence or if FDA cannot determine whether the foreign health authority
reviewed or concurred with the same evidence, then the requirement in section 802(b)(3) of the Act has not been met.
Similarly, FDA has received requests under section 802(b)(3) of the Act where the requesting party states that the
foreign government “does not object” to the product’s importation; the foreign government’s acquiescence to
importation does not satisfy section 802(b)(3) of the Act’s requirement that the foreign government concur that the
scientific evidence provided to FDA is credible scientific evidence of the drug’s safety and effectiveness. A letter from
the relevant foreign government entity addressing each item in this paragraph will, in most circumstances, be
acceptable.
Exports under section 802(b)(3) of the Act, therefore, differ from exports under section 802(b)(2) of the Act in two
important respects: (1) Exports under section 802(b)(3) of the Act involve the submission of scientific evidence to FDA
and to foreign health authorities; and (2) exports under section 802(b)(3) of the Act are situation-specific (i.e., they pertain
to a specific drug intended for export to a specific country).
Because of these differences, a decision to allow exports of a particular drug under section 802(b)(3) of the Act does not
extend to other drugs. Section 802(b)(3) of the Act requires a person to provide FDA with “credible scientific evidence”
that the drug will be safe and effective under the conditions of use in the foreign country, and the foreign country must
concur that the scientific evidence provided to FDA is credible scientific evidence that the drug would be reasonably safe
and effective. However, because drug products may differ in formulation, dosage, route of administration, or other
respects, scientific evidence to show that one drug is safe and effective may not necessarily show that another drug,
made by a different firm or even the same firm, is safe and effective. As a result, the Act’s emphasis on providing and
reviewing credible scientific evidence will, in most cases, prevent a person from relying on an earlier decision to allow
exportation under section 802(b)(3) of the Act.
FDA has 60 days to act on a request to export a drug under section 802(b)(3) of the Act. The agency plans to begin the
60 day period on the date that it receives a complete petition containing the certification and evidence required by the Act.
Please note, however, that while FDA tries to act on export requests expeditiously, the Act does not allow exportation to
proceed if FDA has not responded within 60 days.
As a reminder, any person who exports a drug under section 802 of the Act also must comply with the basic export
requirements set forth in section 802(f) of the Act and with the recordkeeping requirements in section 802(g) of the Act.
Persons who wish to export a drug under sections 802(b)(2) or 802(b)(3) of the Act should address any questions to, and
send their documentation or requests to:
(For Biological Products)
Division of Case Management (HFM-610),
Center for Biologics Evaluation and Research,
Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448.
(For Drug Products)
Executive Secretariat Team (HFD-6),
Center for Drug Evaluation and Research,
1451 Rockville Pike,

VIII. Exports of Unapproved Drugs and Devices for

Investigational Use to Listed Countries Under Section
802(c) of the Act

A. Historical Background

The 1986 Amendments did not impose any special requirements for drugs or devices exported for investigational use.
Moreover, FDA did not apply section 801(e) of the Act to investigational drugs because courts had interpreted section 801
of the Act as not applying to “new drugs.” As a result, FDA regulated the exportation of unapproved new drugs (including
biological products) for investigational use under its authority over investigational drugs at section 505(i) of the Act.
FDA issued regulations governing the exportation of unapproved new drugs for investigational use on January 18, 1984
(49 FR 2095), with minor modifications between 1984 and 2002. These regulations were codified at 21 CFR § 312.110,
and so the program became known as the “312 program.” The regulations required any person who intends to export an
unapproved new drug product for use in a clinical investigation either to have an IND or to submit a written request to
FDA. The regulations required the written request to provide sufficient information about the drug to satisfy FDA that the
drug is appropriate for investigational use in humans, that the drug will be used for investigational purposes only, and that
the drug may be legally used by the consignee in the importing country for the proposed investigational use. The
regulations further stated that the request must specify the quantity of the drug to be shipped and the frequency of
expected shipments. If FDA authorized exportation of the drug, it would notify the government of the importing country.
The regulations, however, did not apply to drugs approved for export under section 802 of the Act or section 351(h)(1)(A)
of the PHS Act. As discussed in part VIII.B., below, the agency recently issued a final rule to modify the regulations for the
312 program.
In contrast, the agency did apply section 801(e) of the Act to investigational devices. This was partly because, unlike the
situation for drugs, the Act contains only one definition for “device.” The agency issued a regulation on device exports on
January 18, 1980 (45 FR 3732 at 3751). The provision, codified at § 812.18(b), simply stated that a person who intends to
export an unapproved device must obtain FDA approval (under what is now part of section 801(e)(2) of the Act) before
exporting the device.
B. Impact of the 1996 Amendments on Drugs Exported for

Investigational Use
The 1996 Amendments impacted the 312 program significantly by creating a new section 802(c) of the Act. In brief,
section 802(c) of the Act permits a firm to export an unapproved drug for investigational use in any of thelisted countries
without prior FDA approval or even an IND. The only requirements are that the drug be exported in accordance with the
laws of the foreign country and comply with the basic export requirements in section 802(f) of the Act. The exporter, under
section 802(g) of the Act, must also maintain records of all drugs exported and the countries to which they were exported.
It is important to note that section 802(c) of the Act allows exports of drugs and devices “intended for investigational
use in any [listed] country...in accordance with the laws of that country” (emphasis added). The key statutory phrase is
that the drug or device must be intended for investigational use in a listed country. FDA is aware that some firms have
interpreted section 802(c) of the Act as allowing shipments of investigational drugs or devices to an unlisted country (a
practice known as “transshipment”) as long as the shipment passes through a listed country. FDA disagrees with such an
interpretation because the unrestricted transshipment of investigational drugs and devices from listed to unlisted countries
would undermine the express limitation in section 802(c) of the Act.10 There is no indication that Congress intended to
make listed countries act as mere transfer points for investigational drugs or devices that are destined for unlisted
countries.
Exports under section 802(c) of the Act are subject to the recordkeeping requirement in section 802(g) of the Act. FDA
regulations pertaining to such records can be found at 21 CFR 1.101(e). These exports, however, are not subject to the
notification requirements of section 802(g) of the Act.
Additionally, as an alternative to section 802(c) of the Act in some circumstances, section 802(b)(1) of the Act authorizes
exportation of an unapproved product, including an investigational new drug, to unlisted countries if the drug complies with
the foreign country’s laws and has valid marketing authorization in a listed country. Thus, exports under section 802(b)(1)
of the Act may be made for investigational uses as well as for marketing purposes.
For exports of drugs for investigational use in unlisted countries where the drug product has not received valid marketing
authorization in a listed country, the “312 program” requirements at § 312.110 remain applicable. On November 23, 2005,
FDA issued a final rule to modify the regulations for the “312 program” (see 70 FR 70720). This final rule describes four
mechanisms for exporting an investigational new drug product:
 First, the export may occur if the foreign clinical trial is covered by an IND. This means that the conduct of the
foreign clinical trial will comply with FDA’s IND requirements.
 Second, if the drug has marketing authorization in any country that is listed or described in section 802(b)(1)(A)
of the Act, it may be exported to any country, including for investigational use. Neither an IND nor prior FDA approval is
necessary. This mechanism corresponds to section 802(b)(1)(A) of the Act, and exports under this provision are
subject to certain statutory requirements. For example, the export must not conflict with the foreign country’s laws.
Federal law also requires firms to notify FDA when they export products under section 802(b)(1) of the Act.
 Third, the export may occur if the drug is to be used in a clinical investigation in any country that is listed or
described in section 802(b)(1)(A) of the Act. Neither an IND nor prior FDA approval is necessary. This mechanism
corresponds to section 802(c) of the Act, and exports under this provision are subject to certain statutory requirements.
However, federal law does not require firms to notify FDA when they export drugs under section 802(c) of the Act.
 Fourth, the export may occur, without prior FDA approval and without an IND, upon submission of a certification
that the drug and export meet certain conditions as specified in the rule. This mechanism is the revised “312 program.”
In brief, the would-be exporter must certify to all of the following:
o The drug is intended for export;
o The drug is intended for investigational use in a foreign country;
o The drug meets the foreign purchaser=s or consignee=s specifications;
o The drug is not in conflict with the foreign country=s laws;
o The outer shipping package is labeled to show that the drug is intended for export from the United
States;
o The drug is not sold or offered for sale in the United States;
o The clinical investigation will be conducted in accordance with § 312.120;
o The drug is manufactured, processed, packaged, and held in substantial conformity with good
manufacturing practices;
o The drug is not adulterated within the meaning of section 501(a)(1), (a)(2)(A), (a)(3), (c), or (d) of the
Act;
o The drug does not present an imminent hazard to public health, either in the United States, if the drug
were to be reimported, or in the foreign country; and
o The drug is labeled in accordance with the foreign country’s laws.
The revised “312 program” also contains special provisions for exportation of an investigational new drug in the event of a
national emergency in a foreign country where the national emergency necessitates exportation of an investigational new
drug. The “national emergency” aspect of the “312 program” contemplates two different scenarios. In the first, the
investigational new drug is to be stockpiled in the foreign country in anticipation of a national emergency so that the drug
may be available for use if and when the national emergency arises. In the second, the investigational new drug is needed
for use in a sudden and immediate national emergency in a foreign country. FDA developed the “national emergency”
provisions for the “312 program” due to growing concerns about the possible use of biological, chemical, or other
weapons in a terrorist attack and to the sudden emergence of new diseases. The “national emergency” provisions allow
an exporter to export a drug under the “312 program” without making one or more of the certifications, but it also requires
the Department of Health and Human Services to make certain decisions and, for stockpile situations, requires FDA to
approve exportation before exportation occurs.
Since enactment of the 1996 Amendments, most exports of investigational new drugs have occurred under section 802(c)
of the Act or under the 312 program.
C. Impact of the 1996 Amendments on Devices Exported for

Investigational Use
The 1996 Amendments also significantly affected investigational device exports. Section 802(c) of the Act permits a firm
to export an unapproved device for investigational use in any of the listed countries, without prior FDA approval or an IDE.
As in the case for drugs, the device must be exported in accordance with the laws of the foreign country, and the exports
are subject to the recordkeeping requirement in section 802(g) of the Act as implemented by 21 CFR 1.101(e).
Yet, unlike the situation for drug exports, the 1996 Amendments permit device firms to export a device either under
section 801(e)(2) of the Act or under section 802 of the Act. The authority selected is important because each section of
the Act carries its own statutory requirements.
For example, if company F wants to export an unapproved device for investigational use to a listed country, it could:
 Export the device under section 801(e) of the Act. Under this provision, the exporter would need to comply with
section 801(e)(1) of the Act and, depending on the device, might have to comply with section 801(e)(2) of the Act and
submit information that would enable FDA to determine that exportation is not contrary to the public health and safety
and that the foreign country approves of the exportation, or
 Export the device under section 802(b)(1)(A) of the Act if the device has received valid marketing authorization
in any listed country. Section 802(b)(1)(A) of the Act permits exportation of an unapproved device, for any purpose, if
the device complies with the laws of the foreign country and has received valid marketing authorization in a listed
country. Exports under section 802(b)(1) of the Act may also occur to unlisted countries so long as the device complies
with the foreign country’s laws and has valid marketing authorization in a listed country. Exports under this option must
comply with the basic export requirements at section 802(f) of the Act (such as being in “substantial conformity” with
cGMPs or meeting international standards as certified by a recognized international standards organization recognized
by the Secretary and complying with section 801(e)(1) of the Act) and the notification and recordkeeping requirements
in section 802(g) of the Act, or
 Export the device to a listed country under section 802(c) of the Act, without prior FDA approval or the
submission of any information to FDA. However, under this option, compliance with the basic export requirements in
section 802(f) of the Act and the recordkeeping requirement in section 802(g) of the Act and § 1.101(e) is necessary.
FDA’s regulation at 21 CFR § 812.18 reflects the options for exporting a device for investigational use, stating that a
person exporting an investigational device subject to part 812 must obtain FDA’s prior approval under section 801(e)(2) of
the Act or comply with section 802 of the Act.
A firm has the additional option of conducting the investigation under an IDE, in which case the IDE requirements in part
812 would apply to the export.

IX. Exports of Unapproved Drugs and Devices in

Anticipation of Foreign Approval - Section 802(d) of the
Act

Section 802(d) of the Act permits the exportation of an unapproved drug, biological product, or device “intended for
formulation, filling, packaging, labeling, or further processing in anticipation of market authorization” in any of the listed
countries. The only requirements for such exports are that:
 the use of the product must comply with the laws of the foreign country,
 the export must comply with the requirements in section 802(f) of the Act, and
 records for such exports must be kept in accordance with section 802(g) of the Act.
The range of activities covered under section 802(d) of the Act is very broad, although mere storage of an unapproved
drug, biological product, or device would not constitute “formulation, filling, packaging, labeling, or further processing.”
Additionally, FDA interprets the phrase “in anticipation of market authorization” as meaning that the firm exporting the
product has filed an application or submission to obtain final marketing authorization in the foreign country. FDA does not
consider an intent to seek market authorization or to file a marketing application at some future time to constitute
“anticipation of market authorization.”
FDA also does not interpret section 802(d) of the Act as allowing anyone to export a drug as long as someoneis seeking
market authorization, irrespective of the laws of the foreign country at issue. Section 802(d) of the Act is commonly
referred to as allowing firms to “fill the pipeline” so that a product will be available immediately upon market authorization
by a foreign country. To interpret section 802(d) of the Act as allowingany firm to export the product so long
as someone was seeking market authorization would essentially ignore the word “anticipation” of market authorization.
Arguably, if a firm has not applied for market authorization, it cannot be “anticipating” market authorization. Thus, the word
“anticipation” in section 802(d) of the Act suggests that the firm exporting the drug, biological product, or device is, in fact,
the entity that is seeking market authorization or would be able to distribute that drug, biological product, or device legally
upon marketing authorization.
Consequently, FDA interprets section 802(d) of the Act as follows. If the foreign country’s product approval process is
specific to an application (i.e., to have marketing authorization, a firm must submit an application, and the application must
be approved), then a firm seeking to invoke section 802(d) of the Act to export a drug, biological product, or device to a
foreign country must be seeking market authorization in that foreign country.
If, however, the foreign country’s product approval process would allow multiple products on the market upon market
authorization (i.e., once marketing authorization occurs, any person can market a drug, biological product, or device that
meets the conditions of that marketing authorization), then a firm seeking to invoke section 802(d) of the Act to export a
drug, biological product, or device to such a foreign country does not have to be the firm that sought marketing
authorization in that foreign country.
This interpretation of section 802(d) of the Act acknowledges both the particular marketing authorization process in a
foreign country and gives appropriate weight to the words “in anticipation of market authorization.”
Please note that exports in anticipation of market authorization under section 802(d) of the Act are not subject to the
simple notification requirement in section 802(g) of the Act. Instead, the exporter would send the simple notification to
FDA once it receives market authorization and begins to export the product under section 802(b)(1)(A) of the Act.

X. Exports of Drugs and Devices for Diagnosing,

Preventing, or Treating a Tropical Disease or a Disease
“Not of Significant Prevalence in the United States” -
Section 802(e) of the Act

The 1986 Amendments authorized exports of unapproved new drugs and biological products intended to prevent or to
treat a tropical disease. Under the 1986 Amendments, the exporter had to submit an export application to FDA. The
export application had to:
 Describe the drug being exported,
 list each country to which the drug would be exported,
 contain a certification that the drug would not be exported to a country if the agency could not find that the drug
would be safe and effective in that country,
 identify the establishments where the drug is made, and
 show that other statutory requirements (such as compliance with cGMP’s) are met.
FDA had to approve the export application before exportation could proceed.
The 1996 Amendments amended the tropical disease provision in several ways. The provision now covers drugs,
including biological products, intended to diagnose, prevent, or treat tropical diseases; includes devices among the
products eligible for exportation; and includes drugs, biological products, and devices that are intended to treat diseases
that are “not of significant prevalence” in the United States. A disease that is “not of significant prevalence” in the United
States can be one that is not manifested in many Americans (either because the pathogen is not common or because
available treatments have made the disease rare in the United States) or is indigenous to a particular foreign country or to
an area in another country. For example, measles may be considered to be a disease that is not of significant prevalence
in the United States because most children are immunized against measles. As another example, poliomyelitis would be a
disease that is not of significant prevalence in the United States because a Pan American Health Organization program
eliminated polio in the Western Hemisphere in 1991.
However, like the 1986 Amendments, the 1996 Amendments require FDA to approve an export application before the
product can be exported (see section 802(e) of the Act). The export application should contain information showing that
the drug or device is intended for use in the treatment of a tropical disease or a disease that is not of significant
prevalence in the United States. Additionally, the application should contain information that will enable FDA to determine
whether the drug, biological product, or device:
 Will not expose patients in the foreign country to an unreasonable risk of illness or injury, and
 will have a probable benefit to health that outweighs the risk of injury or illness from its use, taking into account
the probable risks and benefits of currently available drug or device treatment, provided that the product is used under
conditions prescribed, recommended, or suggested in the labeling or proposed labeling. This includes information on
the illness to be treated, the drug’s risks, and the drug’s benefits. By “currently available drug or device treatment,” the
applicant should consider the availability of products that are approved for the particular disease as well as those that
are commonly used to treat the disease, even if the product is not approved for that indication.
FDA has not received any applications under section 802(e) of the Act. FDA will use a case-by-case approach on any
application received under section 802(e) of the Act until it acquires sufficient expertise to state general criteria for these
applications.
Persons interested in submitting an application under section 802(e) of the Act should contact the offices listed in part XII
of this document.

XI. Export Notification and Recordkeeping Under

Section 802(g) of the Act

Section 802(g) of the Act requires persons exporting a drug or device under section 802(b)(1) of the Act to provide a
“simple notification * * * identifying the drug or device when the exporter first begins to export such drug or device” to any
country listed in section 802(b)(1) of the Act. If the product is to be exported to an unlisted country, section 802(g) of the
Act requires the exporter to provide a simple notification “identifying the drug or device and the country to which such drug
or device is being exported.”
With respect to all exports pursuant to section 802 of the Act, section 802(g) of the Act requires the exporter to maintain
records of all drugs or devices exported and the countries to which they were exported.
A. The Content of the Simple Notification

FDA regulations, at 21 CFR 1.101(d), prescribe the content of the simple notification. The simple notification must contain:
 The product’s trade name,
 if the product is a drug or biological product, the product’s abbreviated or proper name or, if the product is a
device, the type of device,
 if the product is a drug or biological product, a description of the product’s strength and dosage form or, if the
product is a device, the product’s model number, and
 if the export is to a country not listed in section 802(b)(1) of the Act, the country that is to receive the exported
article. The notification may, but is not required to, identify countries listed in section 802(b)(1) of the Act or state that
the export is intended for a listed country without identifying the listed country. FDA acknowledges that section 802(g)
of the Act and § 1.101(d) require exporters to identify the country that is to receive the exported product only if the
country is not a listed country. However, FDA encourages exporters to identify listed countries that are to receive the
exported product. Identification of the foreign country, regardless of whether it is listed or not, will make it easier for
FDA to meet its obligations under sections 802(a) and 802(f)(4), (f)(5), and (f)(6) of the Act which prohibit exports under
certain conditions (such as a finding of an imminent hazard to the public health) and/or require FDA to consult with the
“appropriate public health official” in the affected country.
If a firm declines to identify a listed country in its simple notification, FDA strongly recommends that the firm state that it
exported the product to a listed country. This will inform FDA that the omission of a foreign country’s name was not an
oversight. If it later becomes necessary for FDA to contact foreign health officials in a listed country, FDA will inspect the
exporter’s records to determine where the exported products were sent. Inspections consume both time and resources for
FDA and the affected firm, so FDA encourages voluntary disclosure of the listed countries receiving an exported product.
B. Where to Send the Simple Notification

Notifications should be sent to the following addresses:
For biological products and devices regulated by the Center for Biologics Evaluation and Research (CBER):
Office of Compliance and Biologics Quality,
For human drug products and biological products regulated by the Center for Drug Evaluation and Research (CDER):
CDER/Office of Compliance
Division of New Drugs and Labeling Compliance
WO Bldg. 51
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
For devices:
Division of Program Operations (HFZ-305),
Center for Devices and Radiological Health,
2094 Gaither Rd.,
Rockville, MD 20850.
C. Recordkeeping
As stated earlier, section 802(g) of the Act requires exporters to maintain records of all drugs and devices exported and
the countries to which the products were exported. As provided by 21 CFR 1.101(e), this includes, but is not limited to,
records showing:
 The product’s trade name,
 if the product is a drug or biological product, the product’s abbreviated or proper name or, if the product is a
device, the type of device,
 if the product is a drug or biological product, a description of its strength and dosage form and the product’s lot
or control number or, if the product is a device, the product’s model number,
 the consignee’s name and address, and
 the date on which the product was exported and the quantity of product exported.
FDA regulations require that these records be kept at the site from which the products were exported or manufactured,
and be maintained for the same period of time as required for records subject to good manufacturing practice or quality
systems regulations applicable to the product. Under 21 CFR 1.101(e)(2), the records must be made available to FDA,
upon request, during an inspection for review and copying by FDA.11
FDA regulations, at 21 CFR 1.101(b), also require records demonstrating compliance with section 801(e)(1) of the Act.
The requirements for records demonstrating compliance with section 801(e)(1) of the Act are different from those required
under section 802(g) of the Act. This guidance document discussed section 801(e)(1) of the Act and records in part V,
above. Thus, because exports under section 802 of the Act must comply with the requirements in section 802(f) of the
Act, and section 802(f) incorporates section 801(e)(1) of the Act, exports under section 802 of the Act must comply with
the recordkeeping requirements of both 21 CFR 1.101(b) and 1.101(e).
Additionally, FDA reminds parties that they may need to maintain other records beyond those specified in section 802(g)
of the Act. For example, firms whose products must be in substantial conformity with cGMP’s under section 802(f)(1) of
the Act may be subject to cGMP recordkeeping requirements under the regulations that apply to their products.

XII. For Further Information Contact:

For animal drugs:
Division of Compliance (HFV-230),
Center for Veterinary Medicine,
7519 Standish Place
Rockville, MD 20855,
240-276-9200
For biological products and devices regulated by CBER:
Office of Compliance and Biologics Quality,
Rockville, MD 20852-1448,
301-827-6201.
For devices:
Division of Program Operations (HFZ-305),
Center for Devices and Radiological Health,
2094 Gaither Rd.,
240-276-0132
For drugs and biological products regulated by CDER:
CDER/Office of Compliance
Division of New Drugs and Labeling Compliance
WO Bldg. 51
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
301-827-8930.
For drugs exported for investigational use under § 312.110:
Office of International Programs (HFG-1),
5600 Fishers Lane,
301-443-4480.
For foods and cosmetics:
Division of Enforcement (HFS-605),
Office of Compliance,
Center for Food Safety and Applied Nutrition,
5100 Paint Branch Parkway,
College Park, MD 20740
1-888-723-3366
These offices listed above may have additional guidance documents and information on specific export topics or products.
For general policy questions:
Office of International Programs (HFG-1),
5600 Fishers Lane,
301-827-4480 or 404-253-1221

Footnotes:

1. This guidance has been prepared by the Office of International Programs in the Office of the Commissioner in
cooperation with the Center for Veterinary Medicine, Center for Biologics, Center for Devices and Radiological Health,
Center for Drug Evaluation and Research, and Center for Food Safety and Applied Nutrition at the Food and Drug
Administration.
This guidance document may be supplemented by other guidance documents on specific topics.
2. Public Law 107-188, enacted on June 12, 2002.
3. The 1986 Amendments did not alter the export requirements for insulin and antibiotics. These products remained
subject to the basic export requirements that are now in section 801(e)(1) of the Act because the products were subject to
approval under provisions of the Act separate from section 505 of the Act and, as a result, exports could occur without
prior FDA approval under section 802 of the Act.
4. Section 802(f)(3) of the Act prohibits exportation of a product under section 802 of the Act if the requirements in section
801(e)(1)(A) through (e)(1)(D) of the Act are not met. The requirements in section 801(e)(1) of the Act also apply to
partially processed biological products exported under section 351(h) of the PHS Act.
5. Under 18 U.S.C. 1001, it is a criminal offense to knowingly and willfully submit false information to the government.
6. A device may be considered to have an approved IDE if an institutional review board determines that the device is a
non significant risk device, and provided the device has met the requirements for non significant risk devices under 21
CFR § 812.2(b).
7. Insulin and antibiotics are excluded from section 801(f) of the Act because they historically have been subject only to
the export requirements now seen in section 801(e)(1) of the Act. In 1997, the Food and Drug Administration
Modernization Act (Public Law 105-115) repealed the separate approval provisions for these products and, as a result,
made them subject to section 505 of the Act. In order to permit insulin and antibiotics to continue to be exported under
section 801(e)(1), the 1997 legislation expressly stated that insulin and antibiotics may be exported without regard to the
requirements in section 802 of the Act so long as they meet the export requirements in section 801(e)(1) of the Act. See
section 802(i) of the Act.
8. Insulin and antibiotics may be exported without regard to the requirements of section 802 of the Act if they meet the
requirements in section 801(e)(1) of the Act. See section 802(i) of the Act and footnote 7, above.
9. The provisions of sections 802(b)(2) and (b)(3) of the Act do not apply to devices. Congress omitted devices from
these provisions because it found FDA’s practice of permitting, under section 801(e)(2) of the Act, exports of devices that
had approved IDE’s to be an acceptable alternative.
10. In contrast, exports to a listed country, followed by shipment to another listed country is permitted under section
802(c) of the Act, provided that the shipments are consistent with the laws of the importing countries, because that
provision permits exportation of an investigational drug or device to any listed country.
11. On July 22, 2002, FDA stated, in response to a petition for reconsideration, that it would exercise enforcement
discretion and not generally take enforcement action regarding § 1.101(b) insofar as it pertains to access to records held
by food and cosmetic exporters while the agency considers whether any changes to that provision are necessary. On
June 1, 2004, FDA published an advance notice of proposed rulemaking seeking comments on this issue (69 FR 30842).

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegist
rationandListing/default.htm
http://fdclaw.com/compliance/drugexport/
http://en.wikipedia.org/wiki/Marketing_authorization
http://en.wikipedia.org/wiki/New_Drug_Application
http://en.wikipedia.org/wiki/Common_Technical_Document
http://en.wikipedia.org/wiki/Common_Technical_Document
http://en.wikipedia.org/wiki/Electronic_common_technical_document
XI. What are FDA's cGMP requirements for drugs, devices and biologics?
FDA's cGMP requirements for drugs are the requirements for the methods to be used in, and the facilities or controls to be used for, the
manufacture, processing, packing, or holding of a drug (including a biologic) to assure that such drug meets the requirements of the Act as
to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess (21
CFR Parts 210 and211).
The cGMP requirements for devices are set forth in the quality system regulation (21 CFR Part 820). The requirements govern the methods
used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all
finished devices intended for human use.
Biological products, depending on their intended use, must meet the cGMP requirements for either drugs or devices. Supplementary
requirements for biological products are in 21 CFR Parts 600-680.
In the United States, all clinical trials submitted to the FDA as part of a drug approval process are independently assessed by clinical
experts within the Food and Drug Administration,[48] including inspections of primary data collection at selected clinical trial sites
Beginning in the 1980s, harmonization of clinical trial protocols was shown as feasible across countries of the European Union. At the same
time, coordination between Europe, Japan and the United States led to a joint regulatory-industry initiative on international harmonization
named after 1990 as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH)[55]
A clinical trials registry, is an official platform and catalog for registering a clinical trial. Some countries require clinical trials being
conducted in that country to be registered, other do not require it, but often strongly encourage it. ClinicalTrials.gov, run by the United
States National Library of Medicine (NLM) was the first online registry for clinical trials and is the largest and most widely used today.
United States[edit]
Main article: clinicaltrials.gov
Clinical trials in the US are registered on clinicaltrials.gov.
Clinicaltrials.gov is the largest clinical trials registry. Clinical trials conducted in the United States are required to be registered in the
registry. As of January 2, 2015, CliicalTrials.gov lists 181,612 studies with locations in 50 US states and in 187 countries. Its registrations
represent about 75% of what is available through the WHO Portal (ICTRP). Despite the fact that important progress has been made, the
efforts of those overseeing ClinicalTrials.gov and the other, smaller, registries do not ensure that the public has an unbiased knowledge
base accessible to all. For example, problems of the concordance between the ClinicalTrials.gov record and the published record have
been identified for many protocol and results items.[23]
The registry traces back to the Health Omnibus Programs Extension Act of 1988 (HOPE or Public Law 100-607) which mandated the
development of a database of AIDS Clinical Trials Information System. It would later be expanded under the Food and Drug Modernization
Act of 1997 (FDAMA or Public Act 105-115). The registry is run by the United States National Library of Medicine (NLM).
http://en.wikipedia.org/wiki/ClinicalTrials.gov
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555014/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555014/

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1.

Basic Information: Cefixime (Content of Fix Care – 200 TAB) is an antibiotic useful

Contents: CEFIXIME 200 MG TAB

Branches: Gynecology, Urology, GP

3004  Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of

300420  Cephalosporins and their derivatives

30042019  Cephalosporins and their derivatives: Other

Export Benefits: FMS – Attach List

Approximate amount of Export Country wise from India:

Commodity: 30042019 OTHER CEPHALOSPORINS AND THEIR

2012- 2013- %Growt 2012- 2013- %Growt

Approximate amount of Import Country wise to India

Commodity: 30042019 OTHER CEPHALOSPORINS AND THEIR

2012- 2013- 2012- 2013-

Major Export markets:

Countries: USA, Vietnam, Ukraine, France, Russia, Myanmar, Philippines, Nigeria,

Major Competing Companies:

Contents: ACECLOFENAC 100MG+PARA 325 MG+SERRATIOPEPTIDASE15MG

Basic Information: Aceclofenac is a phenylacetic acid derivative that inhibits synthesis

Indications: Anti – Inflammation Analgesic, Anti – Pyretic (to reduce temperature).

3004  Medicaments(excluding goods of heading 3002, 3005 or 3006) consisting of

69  Nonsteroidal antiinflammatory, analgesics and antipyratic drugs: Other

Export Benefits: FMS – Attach List

Approximate amount of Export Country wise from India:

Commodity: 30049069 OTHER NONSTEROIDAL ANTIINFLAMATORY, ANALGESTICS AND

2012- 2013- 2012- 2013-

Total 85,262.44 140,772.07 65.10

Major Export markets

Regions: North America, West Europe, CIS, Neighboring countries, Africa

Basic Information: Ambroxol is a clinically proven systemically active moucolytic

Ambroxol Adverse Reactions / Ambroxol Side Effects

Contents: AMBROXOL 30MG + LEVOSALBUTAMOL 1 MG+ GUAIPHENESIN 50

Indications: Cough and Cold

Branches: Gynecology, Pediatrics, GP

Export Benefits: FMS – Attach List

Approximate amount of Export Country wise from India:

Commodity: 30049099 OTHER MEDCNE PUT UP FOR RETAIL SALE

%Grow 2012- 2013- %Grow

Approximate amount of Import Country wise to India:

Commodity: 30049099 OTHER MEDCNE PUT UP FOR RETAIL SALE

Major Export Markets:

Region: North America, Africa, Far East Asia, West Europe

4. DOXYCORE PLUS TAB & DOXYCORE OD TAB

Contents of Doxycore Plus Tab: DOXYLAMINE 10MG+PYRIDOXINE 10MG +

Contents of Doxycore OD Tab: DOXYLAMINE 20MG+PYRIDOXINE 20MG+

3004  Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of

30042039  Antihistaminics drugs; Antacids preparations; Antiulcer drugs; Antiemitics

Export Benefits: FMS – Attach List

2012- 2013- %Growt 2012- 2013- %Growt

Approximate amount of Import Country wise to India:

2012- 2013- 2012- 2013-

Major Export markets:

Region: USA, Europe, Africa, Neighboring countries Europe, CIS, Australia

5. HCT OD TAB & BIOLATE M TAB

Contents of HCT OD TAB: METHYLCOBALAMIN 1500MG + PYRIDOXINE 20

Contents of Biolate M Tab: L-METHYLFOLATE 1MG+BIOTIN 5 MG+ PYRIDOXAL 5

Basic Information: Methylcobalamin is a cobalamin (MeB12) used in peripheral

Indications: Multi Vitamin, Neuropathy, Supplementation for Neuron

Branches: Gynecology, Neurology, GP