PARACETAMOL

CONTENTS

SECTION I PRODUCT CHARACTERISTICS AND SPECIFICATION

SECTION II PRODUCT APPLICATIONS

SECTION III INDIAN MANUFACTURERS

SECTION IV IMPORT/EXPORT LEVEL

SECTION V PRICE DETAILS

SECTION VI INDIAN DEMAND

SECTION VII BROAD OUTLINE OF MANUFACTURING PROCESS

SECTION VIII RAW MATERIAL REQUIREMENTS, UTILITY

AND AVAILABILITY

SECTION IX GLOBAL SCENARIO

SECTION X DISCUSSIONS ON ECONOMIC CAPACITY,

PROJECT COST AND PROFITABILITY PROJECTIONS

SECTION XI SWOT ANALYSIS

SECTION XII FACTORS INFLUENCING THE POSITION FOR

A NEW INDUSTRY AND RECOMMENDATIONS

1
 SECTION I

PRODUCT CHARACTERISTICS AND SPECIFICATION

General Details

Pharmaceutical grade Paracetamol is white. However, on prolonged exposure to air, a grey or pink
colour develops.

Physical properties:

Alternate names Acetaminophen, p-Hydroxy acetanilide, p-acetyl aminophenol,

Acamol, Abensanil
Chemical formula C8H9NO2
Appearance White crystalline powder
Molecular weight 151.16
Melting point 169 to 170.5 deg.C.
PH 5.3 to 6.5 at 25 deg.C.
Density 1.293 gm/cc
Solubility Very slightly soluble in cold water considerably more soluble in
hot water.
It is soluble in methanol ethanol, dimethyl formamide, ethylene
dichloride, acetone, ethyl
acetate. Slightly soluble in ether. It is insoluble petroleum ethers,
pentone, benzene.

Grades and Specification of Paracetamol

Generally, two types of Paracetamol are commercially produced namely powder and granules.

Purity level:

Powder 99.5%
Granules 90%
The granular grade is called 'direct compressible' product which is easier to use for making tablets .

Specification of Paracetamol I.P (Powder) Property

Description White crystalline powder slightly bitter in taste
Assay <99.53%
Solubility About 10% MCOH (as per IP)
Identification Confirm to ABCD of IP
Melting range 169 to 170 deg.C.
pH 10% suspension 5.7
Heavy metals <0.001%
4-amino phenol <0.005%
4-chloro acetanilide <0.001%
Loss on drying <0.1256%

2
Sulphated ash <0.0715%

Specification of Paracetamol Granules B.P.

Description White granules or white granular powder

odourless;slightly bitter taste.
Assay, % by mass 90.59% as C8H9NO2
Solubility Sparingly soluble in water, freely soluble in alcohol,
very slightly soluble in chloroform and in ether.
Identification Test A, IR Absorption spectrum
Melting range Between 168 to 172 deg.C.
Heavy metals Not more than 20 ppm.
4-aminophenol Not more than 0.005%
Related substances By TCL method
Sulphated ash Not more than 0.1%
Loss on drying Not more than 0.5%

3
 SECTION II

PRODUCT APPLICATIONS

Paracetamol is used in the treatment of

*. Reduction of fever
*. Relief of muscle and joint&pain
*. Relief of cold and flu symptoms
*. Relief of common headache

Paracetamol lacks anti inflammatory action in rheumatic disorders. However, it is less toxic than
the Aspirin and does not produce anemia and liver damage, which sometimes result from the
continued use of acetanilide and acetophenotidine.

Paracetamol is also an important intermediate in the manufacture of other pharmaceuticals like the
antimalarial amodiaquine.

Analgesic Action The analgesic action of Paracetamol involves peripheral

and central influences. Paracetamol is a valuable central
analgesic but weak peripheral anti inflammatory agent and
exhibits good and prompt antipyretic action. It does not
stimulate respiration and causes less gastric irritation and
have no effect on cellular metabolism or clotting factors.

Formulations Paracetamol is available as tablets, syrups and injections.

Common side effects Side effects of Paracetamol are rare and usually mild

Usage in pregnant women and Paracetamol is widely used in pregnant women and
nursing mother nursing mothers without any significant adverse effects on
the mother or infant.

Usage in infants and children Paracetamol is safe for use in children with appropriate
adjustments in dosage as per the weight of the child.

4
 SECTION III

INDIAN MANUFACTURERS

There are number of manufacturers of Paracetamol in the country. Earlier, most of the units were
setup in small scale level with low capacities. In view of the uneconomic capacity, several units where
closed in the past.

The important manufacturers of Paracetamol include the following

* Dinesh Chemicals Pvt. Ltd.

Plot No.3, 4 & 5, G.I.D.C.,
Nandesari,Baroda-391 340.

* Investa Chemicals
13/2, Rasulpura,
Secunderabad-500 010

* Jagson Pal & Co.

20,K.Milestone,
Mathura Road,
Faridabad-121 003

* Jehovah Laboratories Pvt. Ltd./Jehovah Organics

Kakarolia,Tal.Jambughoda,Dist Panchmahals,
Gujarat-389 390

* Joy Pharmaceuticals Labs.

17, Pagnispaga,
Indore-4,M.P

* Kumar Pharmaceutical Works Pvt. Ltd.

(At present not in operation)
3/13B,Asafali Road,
New Delhi-110 002

* Rajasthan Drugs & Pharmaceuticals Ltd.,

(A "Miniratna" Enterprises of Govt. of India)
Road No.12, V.K.I. Area,
Jaipur-302 013,

* Regent Chemicals Ltd.

52, M.I.D.C. Industrial Area,
Dhata V, Roha, Dist. Raigad,
Maharashtra.

5
* Rohini Chemicals Pvt. Ltd.,
Regd. Office & Factory
Plot No.54/1 & 2, Site IV
Sahibabad, Dist. Ghaziabad,
Uttar Pradesh

* Smruthi Organics Ltd.

A-165, Balaji Bhavan,
1st Floor, Railway Lines,
Solapur-413 001

* Sarvotham Care Ltd.

Corp. Office :
1-20-248, Umajay Complex,
Ist Floor, Rasoolpura,
Secunderabad-500 003

* Srinivasa Agro Industries & Drugs Pvt. Ltd.

D.No.60-3-26/1, Ashok Nagar,
Near I.T.I. Bus Stop,
Vijayawada - 520 010, A.P.

* Thomson Drugs & Chemicals

Aruvacode, Nilambur-679 329.
Dist. Malappuram, Kerala.

* Triochem Products Ltd.

10-2,MIDC Indl Estate, Ambernath-421 501.
Maharashtra.

* Union Chemicals
14-A,Udyognagar,Udhna,Dist Surat,
Gujarat.

* Vijayalaxmi Drugs & Chemicals

Plot No.12, I.D.A.,
Jeedimetla,Rangareddy,
Andhra Pradesh.

Installed capacity of Paracetamol : Around 18000 tonnes per annum

6
 SECTION IV

IMPORT/EXPORT LEVEL

4.1. Present import level Around 1000 tonnes per annum

Countrywise Imports

Period April 2001 to March 2002

Country Quantity in Kgs

Australia 950
Belgium 16320
Chinese Taipei 32400
China P RP 840125
Indonesia 990
Switzerland 81000
UK 19250
USA 325625

Sample of individual imports of Paracetamol

Period 2002

Name of the Importers Quantity in Value in Rs. Country Date Port

tonnes
Ajanta Pharma Ltd. 12.000 1059567 China 01.01.2002 to Mumbai
08.01.2002
Allianz Impex 14.000 1203837 China 01.02.2002 to Mumbai
09.02.2002
Agog Pharma Ltd. 15.300 1373879 China 01.03.2002 to Mumbai
08.03.2002
Flamingo Pharmls. 32.000 2777096 China 08.04.2002 to Mumbai
15.04.2002
Flamingo Pharmls. 16.000 1367088 China 08.05.2002 to Mumbai
14.05.2002
Flamingo Pharmls. 16.000 1372679 China 03.06.2002 to Mumbai
10.06.2002
Pan Drugs Ltd. 16.000 1771209 China 01.07.2002 to Mumbai
05.07.2002

7
Anti dumping duty on Paracetamol

The Designated Autority in the Commerce Ministry has recommended imposition of

definitive anti dumping duty on all imports of Paracetamol originating in or exported from
China and Taiwan.

Paracetamol is a bulk pharmaceutical active ingredient, displaying analgestic and anti pyretic
properties and used in a number of Rx and OTC drug formulation in the form of powders,
granules, injectibles and tablets.

In its final findings, the authority held that the domestic industry has suffered injury caused by
imports from the subject countries,

Accordingly, it recommended anti dumping duty, which should be the difference between
$3.33 per kg and the landed value of imports in the case of both China and Taiwan.

4.2. Present export level

Countrywise Exports Around 1000 tonnes per annum

Period April 2001 to March 2002

Country Quantity in Kgs

Australia 36000
Benin 7800
Burkina Faso 126
Cameroon 24000
Canada 100
Congo P REP 36155
German F REP 158950
Ireland 12000
Israel 1000
Italy 2700
Jordan 15000
Kenya 24500
Korea RP 150
Malaysia 1560
Mayanmar 290
Mexico 33250
Namibia 6900
Netherland 10000
NetherlandAntil 1023
Niger 760

8
Nigeria 41100
Pakistan 19050
Philippines 10900
Spain 5000
Sri Lanka 1800
Sudan 12005
Switzerland 32500
Tunisia 24000
Uganda 16500
U Arab Emts 150
UK 261125
USA 168500
Zambia 6700

Sample of individual exports of Paracetamol

Period 2002

Name of the Exporters Quantity in Value in Rs. Country Date Port

tonnes
Vamsi Labs P.Ltd. 8.000 875295 Aqaba 01.01.2002 to Mumbai
16.01.2002
Granules India Ltd. 12.000 1621200 Sydney 01.02.2002 to Chennai
15.02.2002
Granules India Ltd. 12.000 2369250 Auckland 11.07.2002 to Chennai
31.07.2002
Newton Pharma 0.100 14550 Dar E Salaam 20.08.2002 to Mumbai
31.08.2002

9
 SECTION - V

PRICE DETAILS

Present price level for Paracetamol Around Rs.148 per kg

Taxes and duties Extra as applicable

10
 SECTION VI

INDIAN DEMAND

Paracetamol is extensively used in India. There are 174 brand names for Paracetamol in India,
which are sold in the market in the formulated form.

Therefore, the market is highly competitive

Indian demand for Paracetamol 10000 tonnes per annum.

Export demand 1000 tonnes per annum

Total demand 11000 tonnes per annum

In spite of the fact that the adequate capacity for Paracetamol in India, the product is still
imported from China, mainly due to the price and credit terms offered.

Growth rate in demand

It can be reasonably projected that the growth rate in demand for Paracetamol would be in the region
of 9 to 10% per annum in the coming years.

11
 SECTION VII

BROAD OUTLINE OF MANUFACTURING PROCESS

Two processes are generally used in the country for the manufacture of Paracetamol.

i) From phenol
ii) From Paranitrochlorobenzene

From phenol

The manufacture of Paracetamol involves preparation of para amino phenol as the first step
and acetylation of para amino phenol to produce Paracetamol as the next step.

Para amino phenol can be prepared from phenol by first converting the phenol to para nitro
phenol with sodium nitrite and sulphuric acid and then converting the nitrosophenol to para
amino phenol by reduction with sodium sulphide and ammonium carbonate.

From Para NitroChloroBenzene

80% of the country's production is presently carried out by the Para nitro chloro benzene
route.

The process by PNCB route is briefly described below.

Para nitro chloro benzene is reacted with caustic soda under pressure of 5 kg/sq.cm and
temperature of 150 deg.C for a period of 8 hours in an autoclave. The product of the
reaction would be Para nitrol phenol (PNP), which would be separated by crystallisation and
filteration.

The PNP would be treated with acetic acid to pH level of 3 and then subjected to reduction,
for conversion of PNP to para amino phenol (PAP).

The Para amino phenol would be acetylated to produce crude Paracetamol.

The product would be further bleached with Activated carbon to produce Paracetamol of
snow white colour. The product would be then dried in a tray dryer and then ground to the
size of 40 microns.

The shop floor operations require careful and optimum control to get satisfactory process
efficiency and quality levels .

Source of technology

Central Drug Research Institute, Lucknow, Uttar Pradesh

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Major plant and machinery and suppliers

Name of the equipment Name of the company

Reactor Chemitherm Plants & Systems P. Ltd.,

30, Anandha Street
Alwarpet, Chennai-600 018

Texel Fabricators Pvt. Ltd.,

335, Sidco Industrial Estate,
Ambattur, Chennai-600 098, Tamil Nadu

Neutraliser Sharplex Agro Process (I) Pvt. Ltd.,

302, Hill View Industrial Estate, LBS Marg
Ghatkopar (W), Bombay-400 086

Crystalliser Excel Industrial Services

White House, D-111/8,Ist Main Road,
Anna Nagar (East)
Chennai-600 102

Richard Engineering (Bombay) Pvt. Ltd.

42, IIF, Veerabadran Street
Near Valluvar Kottam
Nungambakkam, Chennai-600 034

Centrifuge Hydrabad Met Chem. Pvt. Ltd.,

34, C.I.E., Phase II,
Gandhinagar, Opp. IDPL Colony
Hyderabad-500 037

Spark Engineers Pvt. Ltd.,

5/332, State Bank Colony II
Salem-636 004

Tray dryer Richard Engineering (Bombay) Pvt. Ltd.

42, IIF, Veerabadran Street
Near Valluvar Kottam
Nungambakkam, Chennai-600 034

Ganson Ltd.
645, Anna Salai,
Chennai-600 006

Pulveriser ACE Pack Machines

23, V.N. Industrial Estate
Bharathi Colony,Near Athiparasakthi Temple
Peelamedu, Coimbatore-641 004

13
 Frigmaires Engineers
PO Box 16353, 8, Janata Industrial Estate
Senapati Bapat Marg
Opp Phoenix Mill, Lower Parel (W)
Mumbai-400 013

Boiler Cethar Vessels Ltd.,

No.4, Dindigul High Road,
Trichy

Firetech Boilers Pvt. Ltd.

No.211, 2nd Cross,
38th Main, B.T.M. Layout
2nd Stage, Bangalore-68

Refrigeration plant Karna Industries Ltd.

10/67, Industrial Area
Kirti Nagar, New Delhi-110 015

Neptune Refrigeration Co. Ltd.,

153, Mount Road, Chennai-600 002

Air compressor ELGI Equipments Ltd.,

Elgi Industrial Complex III,
Trichy Road,
Singanallur, Coimbatore-641 005

K.G. Khosla Compressors Ltd.,

19.8 KMS, Delhi-Mathura Road,
Faridabad-121 003, Haryana

Kaeser Kompressoren India

9 & 10, Symphony `C' Bldg.,
Range Hill Road
Shivaji Nagar, Pune-411 020

Vacuum pump Southern India Instrumech Pvt. Ltd.,

160, Baba Nagar, Villivakkam
Chennai-600 049

Travaini-Maneklal Vacuum Technology Pvt. Ltd.,

Manek Mahal, 7th Floor,
90, Veer Nariman Road,
Churchgate, Mumbai-400 020

14
Neutch filter Aristo Engineers
J-3, Vikas Udyog Nagar,
Behind Kasturi Tiwer
Phatak-Goddeo Road,
Bhayander (E), Thane-401 105

A.V. Industrial Plastics Corp.

202/Him Shikhar,
1st Floor, Plot No.113
Sector 21, Near Apna Bazar
Nerul, Navi Mumbai-400 706

Bifriends Engineering Works

Klm College, Sant Narsi Mehta Marg,
Parsiwadi, Ghatkopar (W),
Mumbai-400 084

15
 SECTION VIII

RAW MATERIAL REQUIREMENTS, UTILITY AND AVAILABILITY

Raw material requirements for Paracetamol production:

Basis : One tonne of Paracetamol

Para nitrochloro benzene (PNCB) 1.25 tonne

Acetic anhydride 0.76 tonne
Acetic acid 0.34 tonne
Caustic soda 0.75 tonne
Iron powder 0.30 tonne
Hydrose 0.01 tonne
Activated carbon 0.01 tonne
Sulphuric acid 0.25 tonne

Source of raw material availability

Sulphuric acid Coimbatore Pioneers Fertilisers Ltd.,Coimbatore

Activated Active Carbon India Ltd.,Hyderabad

carbon Bleachaid Minerals, Hyderabad
Gowrishankar Chemicals, Karnataka
Indo German Carbons Ltd.,Kerala
Core Carbons Pvt. Ltd. Coimbatore

Caustic soda Chemfab Alkalies & Chemicals Ltd., Pondicherry

SPIC Heavy Chemicals Ltd., Chennai
Chemplast, Mettur, Tamil Nadu

Acetic acid EID Parry (India) Ltd.,Madras

Trichy Distilleries & Chemicals Ltd.,Senthannipuram,

Trichy

PNCB Hindustan Organic Chemicals Ltd., Maharashtra

Deepak Nitrite Ltd., Pune

16
 SECTION IX

GLOBAL SCENARIO

International Scenario for Analgesics:

Worldwide, the OTC analgesics market is worth $5.5 billion per annum, with 5% per year
growth. 40% consumption is in the U.S. 30% in Europe, and 30% in the rest of the world,
mainly Japan and South America.

Of the three important products, Aspirin and Paracetamol have equal market shares and
Ibuprofen has a share half the size. Rhone-Poulenc is the biggest producer worldwide of
Aspirin.

Mallinckrodt is the biggest producer of Paracetamol worldwide, followed by Hoechst

Celanese which has expanded Ibuprofen capacity in Bishop, Texas in a joint"venture with
Boots, UK which developed Ibuprofen. Boots has the biggest share of the Ibuprofen market,
followed by Ethyl.

Global trends for Analgesics

Thanks to the trend toward self-medication and the increasing number of consumers over 65,
internal analgesics, particularly prescription to over-the-counter products, may be poised for a
comeback. In the past few months, there have been several new entrants, starting with
Ketoprofen. Both Whitehall-Robins Healthcare and Bayer Consumer Care received the green
light from the FDA to sell Ketoprofen as an OTC remedy. Sold in a 12.5 milligram dose, both
Orudis KT from Whitehall and Actron from Bayer are expected to be well received, given
their ability to provide quick relief with few side effects.

These products join the growing number of nonsteroidal anti-inflammatory drugs that are now
available in non prescription strength. On a milligram-to-milligram basis, Ketoprofen is said
to be the strongest OTC analgesic on the market today. It has four to six hour dosing
compared with a product like Aleve that lasts for 12 hours.

17
Global market for Paracetamol 60000 tonnes per annum.

Market share for analgesics

Aspirin 24 percent
Paracetamol 46 percent
Ibuprofen 22 percent
Others 8 percent

The international producers of Paracetamol

* Mitsui Pharmaceuticals Inc.,

12-2, Nihonbashi 3-chome,
Chuo-ku, Tokyo 103

* Mitsui Toatsu Chemicals Inc.,

2-5 Kasumigaseki, 3-chome,
Chiyoda-ku, Tokyo-100

* Asiamerica International Inc.,

P.O.Box 22281, Fort Lea, NJ 07024

* Alfa Chem
98, Kings Point Road,
Great Neck, NY 11024-1303

* Graymor Chemical Co. Inc.,

40 Parker Road, Suite 210,
Elizabeth, NJ 07208

* Hoechst Celanese Corporation

Post Box No.428, Bishop, Texas
TX 78343

* Rhone-Poulenc North American Chemicals

Rhone-Poulenc Pharmaceutical Ingredients
CN 7500, Cranbury, NJ 08512-7500

SECTION X

18
 DISCUSSIONS ON ECONOMIC CAPACITY, PROJECT COST AND
PROFITABILITY PROJECTIONS

Economic capacity 240 tonnes per annum

Project cost Rs. 215 lakhs

Assessment of project cost

1. Land

S.No. Description Cost

Rs.in lakhs
1.1 Cost of land of one acre at Rs.5.5 lakh per acre 5.5
1.2 Cost of levelling, laying internal roads/fencing and 0.55
compound wall

Subtotal 6.05

2. Building

S.No. Description Cost

Rs.in lakhs
2.1 Factory building of area 620 sq.m. at Rs.3200/sq.m. 19.84
2.2 Non-factory building of area 60 sq.m.at Rs.4500/sq.m. 2.70
Subtotal 22.54

3. Cost of Plant & Machinery

S.No. Description Cost

Rs.in lakhs
3.1 Cost of basic plant and machinery 75
3.2 Instrumentation and control 5.63
3.3 Pipelines and valves 7.5
3.4 Structurals for erection 3.75
Subtotal 91.88
3.5 Octroi, excise duty, sales tax, etc.at 12% 11.03
3.6 Packaging and insurance charges (2%) 1.84
3.7 Transportation charges (2%) 1.84
3.8 Machinery stores and spares (2%) 1.84
3.9 Foundation charges (2%) 1.84
3.10 Installation charges (2%) 1.84
Total cost of plant and Machinery 112.11

4. Technical know-how fees Rs.2.5 lakhs

19
5. Miscellaneous fixed assets

S.No. Description Cost

Rs.in lakhs
5.1. Electrification 4
5.2. Steam boiler and auxillaries 4
5.3. Water storage tank, borewell etc. 1
5.4. Fuel storage tank 2
5.5. Laboratory equipment 0.8
5.6. Office machinery & equipment 1.6
5.7. Material handling equipment, packaging machinery, 1.5
weigh balance, etc.
5.8. Diesel generator 4.5
5.9. Effluent treatment 1.4
Total 20.8

6. Preliminary & Pre-operative expenses:

S.No. Description Cost

Rs.in lakhs
6.1. Preliminary expenses 0.8
6.2. Pre-operative expenses:- -
6.2.1 Establishment 0.8
6.2.2 Rent rates and taxes 0.8
6.2.3 Travelling expenses 1.2
6.2.4 Interest and commitment charges on borrowings 7.2
6.2.5 Insurance during construction period 3.5
6.2.6 Other preoperative expenses and deposits -
6.2.7 Interest on deferred payment -
Total 14.3

7. Provision for contingency Rs.11.17 lakhs

8. Working capital margin Rs. 26.25 lakhs

9. Total project cost Rs.215 lakhs

10. Means of Finance

Promoter's contribution Rs.86 lakhs

Term loan from financing institutions Rs.129 lakhs
Total project cost Rs.215 lakhs

11. Financial statements

20
Cost of production

A Variable cost Rs. in lakhs

Raw material and utilities 194.32

Spares and maintenance 6.73
Selling expenses 17.76
Total variable cost (A) 218.81

B Fixed cost

Salaries and wages 18

Interest on term loan and working capital loan 37.38
Depreciation 14.46
Administrative expenses 10.66
Total fixed cost (B) 80.5

C. Total cost of production (A+B) 299.11

D. Selling price per kg. (in Rupees) 148

E. Annual sales turnover 355.2

F. Net profit before tax (E-C) 55.89

G. Breakeven point in % 59%

SECTION XI

21
 SWOT ANALYSIS

Strength Steady growth in demand, due to higher

investment in health care in the country

Weakness Competitive product

Opportunity Export market

Threat Mushroom growth

SECTION XII

22
 FACTORS INFLUENCING THE POSITION FOR A NEW INDUSTRY

Paracetamol is currently the safest and most widely used agent in the treatment of fever, muscle and
body aches, flu and cold symptoms. Its side effect are few. It is economical and effective.

The demand for Paracetamol is likely to go up steadily in the coming years due to the following
reasons.

* Increasing percentage of ageing population in the country and consequent increasing demand
for Analgesics.

* Low cost of the drug

* Absence of side effects

* Popularity of the drug due to reputation gained during long years of use.

* Paracetamol has maintained its market share inspite of the competitive analgesics that have
emerged in the market.

The export market for Paracetamol is likely to maintain its growth trends, since the Indian units are
competitive in the global market in terms of quality and product specifications.

Considering the above facts, strong case exists to create additional capacity for Paracetamol in the
country, to meet the growing demand in the coming years.

23