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PARACETAMOL
A. INTRODUCTION
Paracetamol is a widely used basic drug which is used for fever, joint pains, head ache, flu etc by formulating it into tablets, capsules or liquids.
B. PRODUCT USES & SPECIFICATIONS
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
C 8 H 9 NO 2
Appearance White crystalline powder Molecular weight 151. 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. Heavy metals <0.001% 4 - amino phenol <0.005% 4 - chloro acetanilide <0.001% Loss on drying <0.1256% Sulphated ash <0.0715% 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
SPECIFICATION
Specification of Paracetamol Granules B.P. Description White granules or white granular powder odourless;slightly bitter taste. Assay, % by mass 90.59% as C8H9NO 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%
C. MARKET POTENTIAL
The Indian pharmaceuticals market looks poised to grow to $55 billion in 2020, according to a new McKinsey & Company report — “India Pharma 2020: Propelling access and acceptance, realising true potential”. This will be a quadrupling of the market from the $12. billion the industry made in 2009. The report states that the pharma market has the further potential to reach $70 billion by 2020 if aggressive growth efforts are embraced.
Acknowledging existing discontinuities in global pharmaceuticals markets, the report says it is the BRIC countries, including India, that will lead growth in the coming decade. The other countries in the BRIC bloc are Brazil, Russia and China. The Indian pharmaceutical industry has been growing at 13-14 per cent in the past five years, a significant increase over the nine per cent growth witnessed between 2000 and 2005. According to the report, five new opportunities will capture 45 per cent of the market by 2020, growing from the $3-billion industry today to $14-18 billion in 2020. These are patented products, consumer healthcare, biologics, vaccines and public health. Metro and Tier-1 markets, which have been growing at 14-15 per cent in the last five years, will drive growth in the industry. They account for 60 per cent of the Indian pharmaceuticals market today and look set to continue growing to a market size of $33 billion by 2020. This will be the result of rapid urbanisation and the expansion of medical infrastructure. Rural markets, on the other hand, will constitute 25 per cent by 2020, up from 20 per cent currently, while Tier-2 markets will decline from the present share of 20 per cent to 15 per cent. Epidemiological factors such as an increased patient pool by 2020, increasing accessibility to drugs due to an increase in investment in medical infrastructure, a greater acceptance of new medicines and greater affordability are the drivers of this growth. Affordability will result in half of the forecasted growth, with rising incomes and increasing insurance coverage lowering the cost of drugs. Increases in income will result in an additional 73 million people in middle and upper class segments, while 650 million people will have health insurance by 2020. While private insurance will grow by 15 per
Paracetamol is extensively used in India. There are about 300 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 250 00 tonnes per annum. Export demand 3000 tonnes per annum Total demand 28000 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.
D. TECHNICAL ASPECTS
1. INSTALLED CAPACITY
The production capacity of Paracetamol is estimated at 0.8 tonne per day on 3 shift basis and the capacity works out to be 240 tonne per annum.
2. PLANT & MACHINERY Machine name Reactor Nutraliser Crystalliser Centrifuge
Tray drier Pulveriser Boiler Refrigerator Air compressor Vacuum pump Nutech filter Testing laboratory The total value of plant and machinery is estimated at Rs.160. lakhs on turn key basis.
3. 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.
5. LAND & BUILDING
Land required-one acre-cost Rs.15.00 lakhs Building-area required-7000 sq.ft Cost Rs.56.00 lakhs
6. UTILITIES Power: The connected load requirement of power is 100 HP. Water: Water requirement is 5000 litres per day. Man Power Requirement : Category Nos. Monthly Total monthly Salary Salary Per MT Qty Rate Value Rs MTs Rs lakhs PNCB 1.25 300 40000 120. Acetic anhydride 0.76 182 72000 131. Acetic acid 0.34 82 70000 57. Caustic soda 0.75 180 32000 57. Iron powder 0.30 72 70000 50. Hydrose 0.01 2 160000 3. Activated carbon 0.01 2 85000 2. Sulphuric acid 0.25 60 20000 12.
Supervisor 3 9000 27000 Skilled 3 7000 21000 Helpers 6 5000 30000 Accounts/Office Assistant 2 6000 12000 90000 Add : Benefits 20% 18000 Total 108000 Total wages per annum [Rs.lakhs] Rs.12.96 lakhs
7. IMPLEMENTATION SCHEDULE After making arrangements for the finance the project can be implemented in six months period. 8. ASSUMPTIONS Installed capacity per annum Paracetamol- 240 MTS per annum Capacity utilization-Year - 1 60% Year- 2 70% Year- 3 80% Selling price per unit Rs.280000 per MT Raw material at 100% Rs.434.33 lakhs per annum Consumables /Packing materials Rs.2200 per MT Power and Fuel-100% (Rs.lakhs) Rs.61.04 lakhs Wages & salaries - 100% (Rs.lakhs) Rs.12.96 lakhs Repairs & Maintenance- p.m. Rs. Depreciation Written down value method General & administration Expenses per month Rs.
Hyderabad-500 037 Spark Engineers Pvt. Ltd., 5/332, State Bank Colony II Salem-636 004 Tray dryer Sri Rudran Instruments Co, 56 Vaikunda Puram, 2nd^ Street 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 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 Neutch filter 1. Aristo Engineers J-3, Vikas Udyog Nagar, Behind Kasturi Tiwer
FINANCIAL ASPECTS
3. COST OF PRODUCTION & PROFITABILITY STATEMENT
- Land 15. 1. COST OF PROJECT
- Building 56.
- Plant & Machinery 160.
- Technical know how fees 5.
- Other Misc. assets 5.
- Pre-Operative expenses 20.
- Margin for WC 11.
- Capital 99. 2. MEANS OF FINANCE
- Term Loan 173.
- Years [Rs.lakhs]
- Installed Capacity (MT)
- Production/Sales (MT) Utilisation 60% 70% 80%
- Selling Price per MT Rs.280,
- Sales Value (Rs.lakhs) 403.20 470.40 537.
- Raw Materials 260.60 304.03 347.
- Packing materials 3.17 3.70 4.
- Power & fuel 36.62 42.73 48.
- Wages & Salaries 12.96 13.61 14.
- Repairs & Maintenance 2.40 2.64 2.
- Depreciation 25.25 21.49 18.
- Cost of Production 341.00 388.20 435.
- Admin. & General expenses 6.00 6.30 6.
- Selling expenses 8.06 14.11 16.
- Interest on Term Loan 24.22 21.19 15.
- Interest on Working Capital 7.26 7.26 7.
- Total 386.54 437.06 481.
- Profit Before Tax 16.66 33.34 56.
- Provision for tax 5.66 11.33 19.
- Profit After Tax 11.00 22.01 37.
- Add: Depreciation 25.25 21.49 18.
- Cash Accruals 36.25 43.50 55.
6. BREAK EVEN LEVEL
Fixed Cost (FC): [Rs.lakhs] Wages & Salaries 14. Repairs & Maintenance 2. Depreciation 18. Admin. & General expenses 6. Interest on TL 15.
Profit Before Tax (P) 56. BEL = FC x 100 = 57.24 x 80 x 100 FC +P 113.70 100 40% of installed capacity
