Professional Documents
Culture Documents
CONTENTS
SECTION
SECTION
II
PRODUCT APPLICATIONS
SECTION
III
INDIAN MANUFACTURERS
SECTION
IV
IMPORT/EXPORT LEVEL
SECTION
PRICE DETAILS
SECTION
VI
INDIAN DEMAND
SECTION
VII
SECTION
VIII
SECTION
IX
GLOBAL SCENARIO
SECTION
SECTION
XI
SWOT ANALYSIS
SECTION
XII
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
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%
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
Formulations
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
Investa Chemicals
13/2, Rasulpura,
Secunderabad-500 010
Union Chemicals
14-A,Udyognagar,Udhna,Dist Surat,
Gujarat.
SECTION IV
IMPORT/EXPORT LEVEL
4.1.
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
Value in Rs.
Country
Date
Port
Quantity in
tonnes
12.000
1059567
China
Mumbai
Allianz Impex
14.000
1203837
China
15.300
1373879
China
Flamingo Pharmls.
32.000
2777096
China
Flamingo Pharmls.
16.000
1367088
China
Flamingo Pharmls.
16.000
1372679
China
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
Countrywise Exports
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
Value in Rs.
Country
Date
Port
Quantity in
tonnes
8.000
875295
Aqaba
Mumbai
12.000
1621200
Sydney
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
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
Export demand
Total demand
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)
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
12
Reactor
Neutraliser
Crystalliser
Centrifuge
Tray dryer
Pulveriser
13
Frigmaires Engineers
PO Box 16353, 8, Janata Industrial Estate
Senapati Bapat Marg
Opp Phoenix Mill, Lower Parel (W)
Mumbai-400 013
Boiler
Refrigeration plant
Air compressor
Vacuum pump
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)
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
Activated
carbon
Caustic soda
Acetic acid
PNCB
16
SECTION IX
GLOBAL SCENARIO
17
24 percent
46 percent
22 percent
8 percent
Alfa Chem
98, Kings Point Road,
Great Neck, NY 11024-1303
SECTION X
18
Project cost
Land
S.No.
Description
1.1
1.2
2.
6.05
Building
S.No.
Description
2.1
2.2
3.
Description
3.1
3.2
3.3
3.4
4.
Cost
Rs.in lakhs
19.84
2.70
22.54
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
19
5.
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
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.
Rs.11.17 lakhs
8.
9.
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
194.32
6.73
17.76
218.81
Fixed cost
18
37.38
14.46
10.66
80.5
C.
299.11
D.
148
E.
355.2
F.
55.89
G.
Breakeven point in %
59%
SECTION XI
21
SWOT ANALYSIS
Strength
Weakness
Competitive product
Opportunity
Export market
Threat
Mushroom growth
SECTION XII
22
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