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PARACETAMOL

CONTENTS
SECTION

PRODUCT CHARACTERISTICS AND SPECIFICATION

SECTION

II

PRODUCT APPLICATIONS

SECTION

III

INDIAN MANUFACTURERS

SECTION

IV

IMPORT/EXPORT LEVEL

SECTION

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

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

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
Chemical formula
Appearance
Molecular weight
Melting point
PH
Density
Solubility

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


Acamol, Abensanil
C8H9NO2
White crystalline powder
151.16
169 to 170.5 deg.C.
5.3 to 6.5 at 25 deg.C.
1.293 gm/cc
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)
Description
Assay
Solubility
Identification
Melting range
pH 10% suspension
Heavy metals
4-amino phenol
4-chloro acetanilide
Loss on drying

Property
White crystalline powder slightly bitter in taste
<99.53%
About 10% MCOH (as per IP)
Confirm to ABCD of IP
169 to 170 deg.C.
5.7
<0.001%
<0.005%
<0.001%
<0.1256%
2

Sulphated ash

<0.0715%

Specification of Paracetamol Granules B.P.


Description

White granules or white granular powder


odourless;slightly bitter taste.
90.59% as C8H9NO2
Sparingly soluble in water, freely soluble in alcohol,
very slightly soluble in chloroform and in ether.
Test A, IR Absorption spectrum
Between 168 to 172 deg.C.
Not more than 20 ppm.
Not more than 0.005%
By TCL method
Not more than 0.1%
Not more than 0.5%

Assay, % by mass
Solubility
Identification
Melting range
Heavy metals
4-aminophenol
Related substances
Sulphated ash
Loss on drying

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


nursing mother

Paracetamol is widely used in pregnant women and


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.

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

SECTION IV
IMPORT/EXPORT LEVEL
4.1.

Around 1000 tonnes per annum

Present import level

Countrywise Imports
Period April 2001 to March 2002
Country

Quantity in Kgs

Australia
Belgium
Chinese Taipei
China P RP
Indonesia
Switzerland
UK
USA

950
16320
32400
840125
990
81000
19250
325625

Sample of individual imports of Paracetamol


Period 2002
Name of the Importers

Value in Rs.

Country

Date

Port

Ajanta Pharma Ltd.

Quantity in
tonnes
12.000

1059567

China

Mumbai

Allianz Impex

14.000

1203837

China

Agog Pharma Ltd.

15.300

1373879

China

Flamingo Pharmls.

32.000

2777096

China

Flamingo Pharmls.

16.000

1367088

China

Flamingo Pharmls.

16.000

1372679

China

Pan Drugs Ltd.

16.000

1771209

China

01.01.2002 to
08.01.2002
01.02.2002 to
09.02.2002
01.03.2002 to
08.03.2002
08.04.2002 to
15.04.2002
08.05.2002 to
14.05.2002
03.06.2002 to
10.06.2002
01.07.2002 to
05.07.2002

Mumbai
Mumbai
Mumbai
Mumbai
Mumbai
Mumbai

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
Benin
Burkina Faso
Cameroon
Canada
Congo P REP
German F REP
Ireland
Israel
Italy
Jordan
Kenya
Korea RP
Malaysia
Mayanmar
Mexico
Namibia
Netherland
NetherlandAntil
Niger

36000
7800
126
24000
100
36155
158950
12000
1000
2700
15000
24500
150
1560
290
33250
6900
10000
1023
760
8

Nigeria
Pakistan
Philippines
Spain
Sri Lanka
Sudan
Switzerland
Tunisia
Uganda
U Arab Emts
UK
USA
Zambia

41100
19050
10900
5000
1800
12005
32500
24000
16500
150
261125
168500
6700

Sample of individual exports of Paracetamol


Period 2002
Name of the Exporters

Value in Rs.

Country

Date

Port

Vamsi Labs P.Ltd.

Quantity in
tonnes
8.000

875295

Aqaba

Mumbai

Granules India Ltd.

12.000

1621200

Sydney

Granules India Ltd.

12.000

2369250

Auckland

Newton Pharma

0.100

14550

Dar E Salaam

01.01.2002 to
16.01.2002
01.02.2002 to
15.02.2002
11.07.2002 to
31.07.2002
20.08.2002 to
31.08.2002

Chennai
Chennai
Mumbai

SECTION - V
PRICE DETAILS
Present price level for Paracetamol Around Rs.148 per kg
Taxes and duties

Extra as applicable

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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.

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SECTION VII
BROAD OUTLINE OF MANUFACTURING PROCESS
Two processes are generally used in the country for the manufacture of Paracetamol.
i)
ii)

From phenol
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

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SECTION VIII
RAW MATERIAL REQUIREMENTS, UTILITY AND AVAILABILITY
Raw material requirements for Paracetamol production:
Basis : One tonne of Paracetamol
Para nitrochloro benzene (PNCB)
Acetic anhydride
Acetic acid
Caustic soda
Iron powder
Hydrose
Activated carbon
Sulphuric acid

1.25 tonne
0.76 tonne
0.34 tonne
0.75 tonne
0.30 tonne
0.01 tonne
0.01 tonne
0.25 tonne

Source of raw material availability


Sulphuric acid

Coimbatore Pioneers Fertilisers Ltd.,Coimbatore

Activated
carbon

Active Carbon India Ltd.,Hyderabad


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
Paracetamol
Ibuprofen
Others

24 percent
46 percent
22 percent
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

1.1
1.2

Cost of land of one acre at Rs.5.5 lakh per acre


Cost of levelling, laying internal roads/fencing and
compound wall
Subtotal

2.

6.05

Building

S.No.

Description

2.1
2.2

Factory building of area 620 sq.m. at Rs.3200/sq.m.


Non-factory building of area 60 sq.m.at Rs.4500/sq.m.
Subtotal

3.

Description

3.1
3.2
3.3
3.4

Cost of basic plant and machinery


Instrumentation and control
Pipelines and valves
Structurals for erection
Subtotal
Octroi, excise duty, sales tax, etc.at 12%
Packaging and insurance charges (2%)
Transportation charges (2%)
Machinery stores and spares (2%)
Foundation charges (2%)
Installation charges (2%)
Total cost of plant and Machinery

4.

Cost
Rs.in lakhs
19.84
2.70
22.54

Cost of Plant & Machinery

S.No.

3.5
3.6
3.7
3.8
3.9
3.10

Cost
Rs.in lakhs
5.5
0.55

Cost
Rs.in lakhs
75
5.63
7.5
3.75
91.88
11.03
1.84
1.84
1.84
1.84
1.84
112.11
Rs.2.5 lakhs

Technical know-how fees

19

5.

Miscellaneous fixed assets

S.No.

Description

5.1.
5.2.
5.3.
5.4.
5.5.
5.6.
5.7.

Electrification
Steam boiler and auxillaries
Water storage tank, borewell etc.
Fuel storage tank
Laboratory equipment
Office machinery & equipment
Material handling equipment, packaging machinery,
weigh balance, etc.
Diesel generator
Effluent treatment
Total

5.8.
5.9.
6.

Cost
Rs.in lakhs
4
4
1
2
0.8
1.6
1.5
4.5
1.4
20.8

Preliminary & Pre-operative expenses:

S.No.

Description

6.1.
6.2.
6.2.1
6.2.2
6.2.3
6.2.4
6.2.5
6.2.6
6.2.7

Preliminary expenses
Pre-operative expenses:Establishment
Rent rates and taxes
Travelling expenses
Interest and commitment charges on borrowings
Insurance during construction period
Other preoperative expenses and deposits
Interest on deferred payment
Total

Cost
Rs.in lakhs
0.8
0.8
0.8
1.2
7.2
3.5
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
Term loan from financing institutions
Total project cost

11.

Rs.86 lakhs
Rs.129 lakhs
Rs.215 lakhs

Financial statements

20

Cost of production
A

Rs. in lakhs

Variable cost

Raw material and utilities


Spares and maintenance
Selling expenses
Total variable cost (A)

194.32
6.73
17.76
218.81

Fixed cost

Salaries and wages


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

18
37.38
14.46
10.66
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.

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