S.

No Firm name File No

1M/s. Bharat Biotech PSUR/Bharat/JE/13-BD

.
 
 2 M/s. Bharat Biotech PSUR/Bharat/Rota/2016/21
. 
  
 3
 M/s. Bharat Biotech PMS/12/39 /Bharat/09-BD
  .
  
 4
  M/s. Bharat Biotech PMS/Bharat/pent/7/13
  .
  
5
   M/s. Bharat Biotech PSUR/Bharat/Typhoid/13
.  
  
6
   M/s. Bharat Biotech PMS/12-62/Bharat Biotech/09-BD
.  
  
   
  
 
 
 

7M/s. Bharat Biotech PSUR/Bharat/IPV/32/2016-DCGI

.
 
8
 M/s. Bharat Biotech PSUR/Bharat/ Rabies /33/2016-DCGI
. 
  
 9
 M/s. Abott India Limited PSUT/Abott/Influenza/34/2016-DCGI
  .
  
1
   M/s. Bharat PSUR/BIBCOL/b-OPV/2016/32
  0 Immunologicals and
 
.  Biologicals
1 M/s. Bio-Med Pvt Ltd PSUR/Bio-med/Misc/03/2016-DCGI
  
1
 
.1
   M/s. Bio-Med Pvt Ltd PSUR/Bio-med/t-OPV/2016/05
2
 
.1M/s. Bio-Med Pvt Ltd PSUR/Bio-med/Biotyph/2016/01
  
 3
.1M/s. Bio-Med Pvt Ltd PMS/12-95/BMD-2005
  
4
 
.M/s. Biological E Pvt Ltd
1 PSUR/Biological E/DTP/2016/14
  
5
 
.M/s. Biological E Pvt Ltd
1 PSUR/Biological.E/Hep-B/2016/12
  
6
 
.1M/s. Biological E Pvt Ltd PSUR/Biological.E/Hemophilus
  
7
  B/2016/06
.1M/s. Biological E Pvt Ltd PMS/12-29/Bio.E/09-BD
  
 8
.1M/s. Biological E Pvt Ltd PSUR/Biological.E/TT/2016/09
  
 9
.M/s. Biological E Pvt Ltd
2 PSUR/Biological.E/DT/2016/17
  
0
 
.M/s. Biological E Pvt Ltd
2 PMS/4/206/05 DC
  
1
 
.M/s. Biovel Lifesciences
2 PSUR/Biovel/Misc/04/2016-DCGI
  
2
 
.2M/s. Cadila Healthcare PMS/12-47/cadila/09-Bd
  
3
 Pvt Ltd
.
 
 

 
3Pvt Ltd
.
 
 

2 PMS/12-106/cadila/10-BD
4
.
 
 
2 PSUR/Cadila/Trivalent-
 5 Influenza/25/2016-DCGI
.
2 PMS/12-90/Panacea/Bulk-VB
 
6
 
.
 
 
2M/s. Dano vaccine and PSUR/Dano/TT/16/2016-DCGI
 7Biologicals
.2M/s. G.C.Chemie Pharma PMS/4/GCC-75/IVC/07-DCGI
 
 8
Ltd
.
 
 

2M/s. GSK Asia Pvt Ltd PSUR/GSK/Rotavirus/2014/01

9
.3M/s. GSK Asia Pvt Ltd PSUR/GSK/Varicella/2016/19
 
 0
.M/s. GSK Asia Pvt Ltd
3 PMS/12-68/96-DC
  
1
 
.M/s. GSK Asia Pvt Ltd
3 PMS/4-70/GSK/08-BD
  
2
 
.
 
 3 M/s. GSK Asia Pvt Ltd PSUR/GSK/Cervarix/10-BD (III)
3
 
.3M/s. GSK Asia Pvt Ltd PSUR/GSK/Boostrix/2016/04
 
4
 
.
  
 

3M/s. GSK Asia Pvt Ltd PSUR/GSK/Hep-B/17/2016-DCGI

5
.
 
 
3M/s. GSK Asia Pvt Ltd PSUR/GSK/MMRV/20/2016-DCGI
6
 
.
 
 

 
3M/s. HLL Lifecare Pvt Ltd PSUR/HLL/HIVAC-B/2016/03
7
.
 
 

 
3 PSUR/HLL/PENTAHIL/2016/02
8
.
3 PMS/12-03/HLL/11-BD
 
9
 
.4M/s. Human Biologicals PSUR/Human Biological/TT/13-BD
  
0
 Pvt Ltd
.
 
 
4 PSUR/Human Bio/Hepatitis-B/2016/31
 1
.
4 PSUR/HBL/HYD/DTP/2/13-BD
 
2
 
.
 
 
4 PMS/4/SII-86/PNT/CRM/07/DC
 3
. or
 
 
PSUR/Human
  Biologicals/Misc/08/2016/DCGI
4 PMS/04-89/99/13-BD
4
.
 
 

4M/s. MSD PSUR/MSD/Varicella/2016/34

5Pharmaceuticals
.M/s. MSD
4 PSUR/MSD/HPV/GARDASIL/2016/12-29
 
6
 Pharmaceuticals
.M/s. MSD
4 PSUR/MSD/HZ/2016/35
  
7
 Pharmaceuticals
.M/s. MSD
4 PMS/12-75/MSD/10-BD
  
8
 Pharmaceuticals
.
 
 

4M/s. Nirlac chemicals PSUR/Nirlac/Misc/01/2016-DCGI

9
.5M/s. Novartis Healthcare PSUR/Novartis/Influenza/2016/16
 
 0 Pvt Ltd
.M/s. Novartis Healthcare
5 PMS/12-105/Novartis/10-BD
  
1
 Pvt Ltd
.M/s. Novartis Healthcare
5 PSUR/Novartis/Rabies/12/13
  
2
 Pvt Ltd
.M/s. Novartis Healthcare
5 PSUR/Novartis/DTwp-Hep-Hib/2016/15
  
3
 Pvt Ltd
.5M/s. Novo MEDI PSUR/Novo-Medi/Varicella/2016/29
  
4
 
.5M/s. Panacea Biotech PMS/12-72/Panacea/10-BD
  
 5
.5M/s. Panacea Biotech PSUR/Panacea/DTwP/13-BD
  
6
 
.
 
 

 
5M/s. Panacea Biotech PMS/12-20/Penta/02/pancea/6/13
7
.
 
 

5M/s. Panacea Biotech PMS/12-18/Panacea/09-BD

8
.M/s. Panacea Biotech
5 PMS/12-90/97/Panacea/Bulk-VB
 
9
 
.6M/s. Panacea Biotech PMS/4/193/2006-DC
  
0
 
.
 
 

6M/s.Prosper Channel PSUR/Prosper/Rabies/26/2016-DCGI

1Lifesciences
.6M/s. Ranbaxy PSUR/Ranbaxy/Typhoid/13-BD
 
 2 Laboratories
.6 PSUR/Ranbaxy/Hib/13-BD
  
3
 
.
6 PMS/12-102/Ranbaxy/10-BD
  
4
 
.M/s. Sanofi Pasteur India
6 PSUR/Sanofi/Menactra/2016/36
  
5
 Pvt Ltd
.
 
 

6M/s. Sanofi Pasteur India PSUR/Sanofi/rabies/2016/11

6Pvt Ltd
.6M/s. Sanofi Pasteur India PSUR/Sanofi/Yellow fever/2016/07
 
 8 Pvt Ltd
.6M/s. Sanofi Pasteur India PSUR/Sanofi/IPV/2016/24
  
9
 Pvt Ltd
.M/s. Sanofi
7 Pasteur India PSUR/Sanofi Pasteur/Pentaxim/2016/18
  
0
 Pvt Ltd
.
 
 

 
7M/s. Sanofi Pasteur India PSUR/Sanofi Pasteur/Influenza/2016/28
1Pvt Ltd
.M/s. Sanofi Pasteur India
7 PSUR/Sanofi/varicella/19/2016-DCGI
 
2
 Pvt Ltd
.7M/s. Sanofi Pasteur India PSUR/Sanofi/Hexaxim/24/2016-DCGI
  
3
 Pvt Ltd
.7M/s. Serum Institute of PSUR/Serum/t-OPV/2016/26
  
 4 India
.7M/s. Serum Institute of PSUR/Serum/b-OPV/2016/25
  
5
 India
.
 
 

7
 M/s. Serum Institute of PMS/12-76/Serum/09-BD
6India
.7M/s. Serum Institute of PMS/12-63/Serum /09-BD
 
 7 India
.7M/s. Serum Institute of PMS/12-1/Serum/09-BD
  
8
 India
.M/s. Serum Institute of
7 PSUR/Serum/
  
9
 India Influenza/Nasovac/2016/23
.8M/s. Serum Institute of PSUR/Serum/IPV/2016/22
  
0
 India
.
 
 

8M/s. Serum Institute of PSUR/SII/IPV/29/2016-DCGI

1India
.8M/s. Serum Institute of PMS/4/SII-86/PNT/CRM/07-DC
 
2
 India
.
 
 

8M/s. Serum Institute of PSUR/Serum/MMR/21/2016-DCGI

3India
.
 
 

 
8M/s. Serum Institute of PSUR/Serum/Hep-B/22/2016-DCGI
4India
.
 
 

 
8M/s. Sino PharmPvt ltd PSUR/SinoPharm/Varicella/27/2016-
5 DCGI
.M/s. Shantha Biotechnics PSUR/Shantha/r-Hep-B/5/13-BD
8
 
6
 Ltd
.
 
 

 
8M/s. Shantha Biotechnics PMS/12-65/Shantha/09-BD
7Ltd
.M/s. Shantha Biotechnics
8 PSUR/Shan/TT/4/13-BD
 
8
 Ltd
.8M/s. Shantha Biotechnics PSUR/Shantha/r Hep-B/5/13/BD
  
9
 Ltd
.9M/s. Shantha Biotechnics PSUR/Shantha/IPV/2016/20
  
 0 Ltd
.9M/s. Shantha Biotechnics PMS/04-206/05-DCGI
  
1
 Ltd
.M/s. Synergy diagnostics
9 PMS/4/VCRV-13/SDT/07-DC
  
2
 
.M/s. VHB Lifesciences ltd
9 PSUR/VHB/Varicella/28/2016-DCGI
  
3
 
.9M/s. Wockhadrt PSUR/Wockhadrt/Hep-A/2016/08
  
4
 
.9 PSUR/Wockhardt/varicella/2016/10
  
 5
.
 
 

 
9M/s. Pfizer Ltd PMS/12-16/Wyeth/09-BD
6
.
 
 

Green Signal labs

Vaccine Marketing Authorisation no.

Japanese Encephalitis MF-181/2012 dated 06/07/2012

Oral Rotavirus vaccine MF-192/2013 dated 03-09-2013

Bivalent oral poliomyelitis vaccine Type 1, MF-224/10 dated 12-03-2010

type 3
Pentavalent vaccine 23-Jul-08

Typhoid vaccine MF-244/2012 20/12/2012

Adjuvanated H1N1 vaccine (inactivated) MF-487/10 30/09/210

HN-VAC

Inactivated Poliomyelitis vaccine MF-147/2015, 19/06/2015

Rabies vaccine MF-200/2015, 11/09/2015

Influenza vaccine, surface antigen

inactivated
Bivalent Oral Poliomyelitis vaccine MF-78/13 23/04/2013

Rabies vaccine MF-253/2014 dated 20-11-2014

Trivalent poliomyelitis vaccine (oral) MF-188/2013 16.08.2013

Vi polysaccharide typhoid vaccine MF-123/2014 02/06/2014

Meningococcal polysaccharide vaccine MF-7/09 12/01/2009

Diptheria, Tetanus and Pertussis vaccine MF-201/2013, 13.09.2013

Hepatitis-B vaccine MF-197/2013, 05 Sep 2013

Hemophilus Type B

Pentavalent vaccine MF-800/09, 23 Sep 2009

Tetanus toxoid vaccine MF-196/2013, 04/08/2013

Diptheria, Tetanus vaccine (adsorbed)

Liquid Pentavalent vaccine

Vi capsular typhoid vaccine MF-298/09, 24/05/2009

Inactivated Influenza vaccine (Whole virion) MF-446/10, 11 May 2010

IP pandemic influenza (H1N1) 2009,
monovalent vaccine
IP pandemic influenza (H1N1) 2009,
monovalent vaccine

Rabies vaccine, Human MF-320/2011, 16 Aug 2011

Trivalent Influenza vaccine MF-252/2015, 16/12/2015

Oral Poliomyelitis vaccine MF-175/09

2/24/2009

Tetanus toxoid vaccine (adsorbed) MF-145/2013 08/07/2013

Influenza vaccine inactivated IMP-449/09, 12 May 2009

Rotavirus vaccine IMP-8105/07, 19 Nov 2007

Varicella vaccine 19-Jun-98

Inactivated Influenza vaccine MF-458/2011, 18/10/2011

Pneumococcal polysaccharide and non- IMP-102/2011 dated 20-04-2011

typeable Hemophilus Influennza
conjugated vaccine
Human Papilloma virus vaccine (Cevarix)

Diptheria, Tetanus and acellular Pertussis IMP-6056/05 (B), 03 Aug 2005,

vaccine extension of license in 2013

Hepatitis-B vaccine MF-70/2013, 09/09/2013

Measles, Mumps, Rubella and varicella IMP-163/2014, 18/07/2014

virus

Hepatitis-B vaccine (rDNA) MF-243/2014

PENTAHIL Diphthera, tetanous, petrusis MF-245/2014 07/05/2014
(whole cell )Hep-B (rDNA) haemohilus type
b conjugate
Rabies vaccine
vaccine SV-52-109

Tetanus toxoid vaccine

Hepatitis-B vaccine

DTP (adsorbed Diphtheria, tetanus and

Pertussis) vaccine

Rabies vaccine MF-295/09 23/03/2009

Hepatitis-B (rDNA) MF-6491/06, 23 Mar 2006

Varicella virus vaccine IMP-148/14, 03 Jul 2014

Quadrivalent human papilloma virus

vaccine recombinant (Gardasil)
Herpes zoster vaccine live (zostavax MSD) IMP-63/2015 dated 05-03-2015

Rota virus IMP-339/10, 28/04/2010

Influenza vaccine IMP-139/2013, 26 June 2013

Hepatitis-B vaccine (rDNA) IMP-254/11, 02 June 2011

Rabies vaccine

Diptheria, Tetanus, Pertussis (whole cell), IMP-189/2013, 30-08-2013

Hepatitis-B (rDNA), Hib conjugate vaccine
(QUINVAXEM)
Varicella vaccine IMP-183/2015, 14.08.2015

Inactivated H1N1 split virion MF-898/10, 08 Nov 2010

DtwP vaccine MF-822/10, 21.09.2010

Pentavalent vaccine MF-7912/07, 12 Sep 2007

Bivalent polio type 1 , type III vaccine, live, MF-951/09 0911/2009

oral
Oral poliomyelitis vaccine (type 1,2,3) MF-175/09 24/02/2009

DtwP vaccine MF-282/09,

19 Mar 2009

Rabies vaccine IMP-133/2015, 27/05/2015

Typhoid vaccine

Hemophilus Influenza Type B MF-72/12 14/03/2012

Rabies Vaccine, Purified, Verco cell, IMP-647/2010, 22-09-2010

Freezed Dried
Meningococcal A,C,Y and W135 IMP-134/2012, 12/06/2012
polysaccharide

Inactivated Purified vero cell Rabies vaccine

Yellow fever vaccine

Inactivated Poliomyelitis vaccine (IMOVOX) 6686 dated 28-June-2006

Pentaxim (DtaP-IPV-Hib adsorbed

diphtheria, tetanus, type B conjugated
vaccine)
Split virion, inactivated Influenza vaccine
(Vaxigrip)
Varicella vaccine (Okavax)

Hexaxim vaccine IMP-53/2016, 17 Mar 2016

Trivalent poliomyelitis vaccine (oral)

Bivalent Oral poliomyelitis vaccine

Influenza virion activated pandemic H1N1 MF-242/2011, 02 Jun 2011

vaccine, embryonated, hen egg derived and
inactivated
Influenza vaccine live attenuated freeze
dried (Nasovac)
Conjugated meningococcal vaccine MF-458/2011, 18 Oct 2011

Influenza vaccine live attenuated human MF-242/11, 2/06/2011

seasonal trivalent freeze dried
Inactivated Poliomyelitis vaccine POLIOVAC IMP-134/09 17/02/2009
(PFS)

Inactivated Poliomyelitis vaccine IMP-231/2015, 27/11/2015

Pentavalent vaccine MF-167/09, 12 Feb 2009

Measles, Mumps and rubella vaccine

Hepatitis-B vaccine (rDNA)

Varicella vaccine IMP-145/2015, 18/16/2015

Hepatitis-B vaccine (rDNA)

Oral cholera vaccine MF-176/09 24/02/2009

Tetanus toxoid vaccine 1997

Hepatitis-B vaccine

Inactivated Poliomyelitis vaccine MF-147/2015, 19 Jun 2015

Pentavalent vaccine MF-7225/07, dated 23-Feb-2007

Rabies vaccine IMP-810/09, 21 Oct 2009

Varicella vaccine IMP-170/2015, 04/08/2015

Hepatitis-A live attenuated, Biovac-A

Varicella vaccine, Biovac-V IMP-139/14, 18/06/2014

Pneumococcal saccharide conjugate IMP-237/2010,

vaccine
18-Mar-10
 letter
dated
Letter 11-
Jan-17
sent forfor
4
5 yeaeon
years
PSUR Periods
sales
16-Aug-and
safety
2013
Oct /2014 to Mar/2015 Letter
data
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letter for
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Oct /2015 Jun-2013
response
PSUR
for on
PSUR,
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16-01-
JAN/2012 to June/2012 However
2015
firm
July/2012 to Dec/2012 One more
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to June/2013
Dec/ 2011 letter
PSURson
Jan/2015 to Dec/2015 31-01-17
from Oct
JAN/2015 to JUNE/2015 Query
14
JULY/2015 to DEC/2015 reponse
JAN/2016
JULY to DEC
2012 to JUNE /2016
2012 to 5 year
Letter for
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DEC/2016
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PSUR sent
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17
09/2013 to 08/2014
09/2014 to 02/2015 Stopped marketing
03/2015
June 2014toto08/2015
Nov-2014
01/09/2015
Dec-2014 to to 30/03/2016
May-2015
June 2015
2009 to 2010to Nov-2015
2010 to 2012
july/2010 to to
04/03/2014 Dec/2010
03/09/2014
jan/2011
04/09/2014to june/2011
to 03/03/2015
july/2011
04/03/2015
06/03/2014 to to
june
to 2012
03/09/2015
05/09/2014
06/09/2014 to 05/03/2015
06/03/2015
31/10/2014 to to 05/09/2015
30/04/2015
01/05/2015 to 31/10/2015
01/05/2016
01/05/2014 to to 31/10/2016
30/04/2015

05/03/14 to 04/09/14
05/09/14 to 04/03/15
05/03/05 to to
12/07/2015 04/09/15
11/07/2016

27/11/2014 to 20/10/2015

01/12/2011 to 31/05/2012

03/2011 to 05/2011

06/2011 to 11/2011
01/12/2011 to 31/05/2012

12/03/2015 to 14/09/2016

16/08/2011 to 15/07/2012

01/08/2014 to 31/07/2015

18/12/2011 to 17/12/2012

18/12/2012 to 17/12/2014

20/05/2015 to 19/05/2016

05/2009 to 07/2011

08/2011 to 02/2012

11/02/2012 to 10/08/2012

11/08/2012 to 10/02/2013

02/2013 to 06/2015

12/07/2013 to 11/07/2014 Letter

01/06/2008 to 11/07/2015 sent on
presented in PSUR
14 /07/14 to meeting (4th)
13/01/15 01/10/20
14/01/15 to 13/07/15 15 for
14/07/15 to to
01/05/2002 13/01/16
30/04/2011 (Soft PSUR
Query Not
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letter sent marketed in
01/05/2011 toto30/04/2012 n
onone 2013 and
01-12-2011 31-05-2012 (LL) Letter
more
01-06-2012 to 30-11-2012 (LL) 27/01/20
dated 26- 2014
letter
17 for sent
5
01/12/2011 To 30/11/2012 Jun-2012
for PSUR
01/12/2013 to 31/05/2014 years
for PSUR
18/11/2008 submissio
01/06/2014 toto 17/05/2009
30/11/2014 Letter
sales and
submissio
n
18/05/2009
01/06/2015 toto 17/11/2010
30/11/2015 dated
safty
n anddata
18/05/2009 31/01/20
01/12/2015 to
03/08/2013 to 17/11/2009
02/08/2014
31/05/2016 (Soft 14/09/20
again
17
(international
01/06/2016 toPSUR
Copy) on CD)
30/11/2016 13 fafter
letter on
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22/10/2013 to 21/04/2014
17/11/2010 (soft PSUR
20-Jun-
(international
copy on CD) PSUR on CD) review
2013 for
18/11/2010
22/04/2014 toto 17/11/2011
21/10/2014 and
PSUR
01/11/2012 to
22/10/2014 to 21/04/2015
30/04/2013 reminder
submissio
01/05/2014 to
22/04/2015 to 21/10/2015
30/04/2015 on
n and
21/10/2015 to 21/10/2016 12/03/20
reminder
1
on 05-11-
2013
No PSUR

License surrendered
06/09/2014 to 05/09/2015 Letter India launch
(International PBRER on CD) sent on is 20 July 16
20-Oct- so 1st 6
2016 for monthly will
PSUR be recieved
submissio by 18 feb
14/11/2014 to 13/03/2015 n
14/05/2015 to 13/11/2015
07/11/2014 to 06/05/2015

23/01/2011 to 23/01/2012

25/01/2013 to 20/02/2015

17/01/2011 to 17/01/2012

19/01/2013 to 28/02/2015

20/01/2009 to 20/12/2010
20/12/2010 to 20/12/2011
09/12/2010
24/03/2016 to
to 08/06/2011
30/09/2016
09/12/2011 to 08/06/2012
09/06/2012 to 08/12/2012
09/12/2012 to 08/12/2013
09/12/2013 to 30/09/2014
17/04/2011
01/02/2015 to
to 17/04/2012
31/08/2016
18/04/2012 to 18/04/2013

19/04/2013 to 30/04/2015

01/05/2015 to 30/09/2016

17/12/2014 to 16/12/2015

01/12/2007 to 31/05/2008
01/12/2008 to 31/05/2009
01/12/2010 to
02/11/2014 to 01/05/2015
31/05/2011 Letter Company
02/05/2015 to 01/11/2015 sent on letter
28/11/2011 to 27/05/2012 03-08-
Letter stating
28/11/2011 to 27/11/2012 2016on
sent for PSUR
28/11/2013 to 27/11/2014 PSUR
10/04/20 submitted
28/11/2014 to 27/11/2015 submissio
15 for
28/11/2015 to 27/11/2016 n
PSUR
submissio
n

01/01/2015 to 30/06/2015
01/07/2015 to 31/12/2015 Letter on 12-01-17 for 5 year sales and safety data
Not
marketed
Letter
from
datedJul18-
12/05/2007 to11/05/2010 2012 to
6-12 for
Query
05/11/2011 to 04/11/2012 Dec
letter2012
PSUR on
Letter on
submissio
02-02-17
01/07/2014 to 31/12/2014 MA
29-5-13
n and
on bases
01/01/2015 to 30/06/2015 transfer
for PSUR
reminder
of
01/07/2015
01/03/2016 to
to 31/12/2015
15/04/2016 to review
GSK
submissio
on
sent08-11-
16-4-2016 to 15-10-16 (email
n
12and
andalso
08/11/2010 to 30/06/2012 attached)
01-02-17 NO
9-Aug-
2016 marketing
21/09/2010 to 30 Jun 2013 Letter on after 2012
27-Jun-13
for PSUR
submissio
n
27/08/2009 to 26/08/2012
02/10/2014 to 01/10/2015
02/10/2015 to 01/10/2016

Letter on
21-Sept-
2013 for
PSUR
submissio
n
Letter on
18-May-
2015 for
PSUR
submissio
n
24/11/2009 to26/02/2012 Letter for
27/02/2012 to 26/08/2012 PSUR
04/01/2012 to
18/12/2011 to 17/12/2012
03/01/2013 submissio
Letter for
27/08/2013 to
18/12/2012 to 17/12/2014
26/08/2014 n 28-May-
PSUR
27/08/2014
21/02/2003 to 26/08/2015
to 20/02/2007 2012
submissio
n 28-May-
19/10/2004 to 18/10/2008 2012

18/12/2008 to 17/12/2011

01/10/2009 to 30/09/2011

27/08/2009 to 26/08/2012

Query
letter
send on
2-1-17 for
19-Jul-13 PSUR
submissio
n
22 Sept 10 to 30 Nov 12 (CD)

12/06/2014 to 11/06/2015 firm stated

12/06/2015 to 11/06/2016 submission
of PSURs
from june
12 to june
14 as well (4
PSURs)

Letter sen
24/02/2015 to 23/08/2015 Query
24/08/2015 to 23/02/2016 letter sent
06/02/2015 to 05/08/2015 for 5 year
Letter
06/08/2015 to 05/02/2016 data
datedon02-
30-Jan-2015 to 29-July-2015 16-01-
02-17
Letter for
30-Jul-2015 to 29-Jan-2016 2017
5 yearand
dated 13
reminder
safety
July 2016
01/04/2014 to 30/09/2014 on
01/10/2014 to 31/03/2015 and02-02-
sent sales
after
2017
data
PSUR
01/04/2015 to 30/09/2015
01/10/2015 to 31/03/2016 review
01/09/2013 to 30/04/2014 Serum
01/05/2014 to 31/08/2014 letter
01/09/2014 to 30/04/2015 dated
stopped25-
01/09/2015 to 15/03/2016 July-2012
in 2013
08/04/2016 stating no
17/03/2016 to
to 07/10/2016
16/09/2016 sales so
no PSUR
07/01/2013 to 31/03/2014 Letter
01/04/2014 to 31/03/2015 dated 09-
01-04-2015
07/01/2013 to
to 31-03-2016
31/03/2014 Aug-2016
Letter
01/04/2014 to 31/03/2015 for
sentPSUR
for 5
submissio
year sales
n
and
Serum
saftety
reply:
data onNo
sales
10-01-17

No PSUR sa no sales
22/01/2010 to 31/03/2011 Letter for
01/04/2011 to 31/03/2012 PSUR sent
01/04/2012 to
06/09/2014 to 31/03/2015
31/03/2013 on 16-08-
9th PSUR
01/04/2013
01/04/2015 to
to 31/03/2014
30/09/2015 2013 and
response
01/04/2012 to 31/03/2014 reminder
Letter Query
01/04/2014 to 31/03/2015 on 05-11- response to
dated
01/04/2015 to 31/03/2016 2013
02/01/20 Meeting
Query
17 for letter dated
letter for 29/11/2016
submissio
last
n of 5 year
sales
pendingand
safety
PSURs
data

01/04/2007 to 30/04/2009
01/04/2009 to 31/03/2010
01/04/2010 to 31/03/2011
01/04/2011 to 31/03/2012
01-04-2012 to 31-03-2013
01-04-2013 to 31-03-2014
01-04-2014 to 31-03-2015
17/03/2016 to 27/10/2016

01-04-2011 to 31-03-2012
01-04-2012 to 31-03-2013
01-04-2013 to 31-03-2014
01-04-2014 to 31-03-2015
01-04-2015 to 31-03-2016

01/04/2011-31/03/2012
01/04/2012-31/03/2013
01/04/2013-31/03/2014
01/04/2014-31/03/2015
01/04/2015-31/03/2016

Not
imported
till date
01/2011 to 05/2012
05/2012 to 05/2013
05/2013 to 05/2014
02/05/2014 to 19/05/2015
20/05/2015 to 19/05/2016
2009 to 2010, 2011 to 2012
25/02/2014 to 24/02/2015
Jul-2011 to Jul-2012
Jul-13 to Jul-14 Letter on Basu sir Sign
16-Jul-14 to 15-Jul-2015
16-Jul-2015 to 15-Jul-2016
19/06/2015 to 18/12/2015 Letter
19/12/2015 to 18/06/2016 dated 02-
01/2008 to 12/2008 01-2017
01/2009 to 12/2009 for PSUR
01/2010
Oct 2009to to12/2010
Oct 2012 submissio
8-9-2014 to 7-9-2015 n
08-03-2015 to 07-09-2015
08-09-2015 to 07-03-2016

16/12/2014 to 15/06/2015

16/12/2015 to 15/06/2016

16/06/2016 to 15/12/2016

Jan 2012 to Jul 2012

10/07/2012 to 09/01/2013

10/01/2013 to 09/07/2013

10/01/2014 to 09/01/2015

10/01/2015 to 09/01/2016

10/01/2016 to 19/07/2016

File to be created