![Detailed Project Report (DPR) on active pharma ingredients (api) [azithromycin, alpha lipoic acid, pregablin, naproxen, ketoprofen]](https://www.eiriindia.org/image/project-report/detailed-project-report-cma-data.png)
Industry Overview
The active pharmaceutical ingredient (API) industry manufactures active pharmaceutical ingredients from raw materials through chemical and physical processes. Depending on molecular complexity, API synthesis may involve multiple reaction stages and a range of processing technologies. APIs, often referred to as bulk pharmaceuticals, are commonly manufactured separately from finished pharmaceutical products such as tablets, suspensions, and liquids.
India and China have become major centers of global API manufacturing, encouraging pharmaceutical companies to outsource production and reduce investment in specialized equipment and infrastructure. Major API manufacturers identified in the report include TAPI (Teva Active Pharmaceutical Ingredients), Dr. Reddy’s, Aurobindo, Cipla, Sandoz-Lek-Biochemie, Ranbaxy, Matrix, and Sun.
API manufacturers must comply with stringent safety and quality requirements in the markets where their products are used, including applicable regulatory inspections and licensing requirements. Environmental sustainability is also increasingly important, with manufacturers seeking to reduce hazardous waste through fewer synthesis steps and the adoption of more efficient, environmentally preferable solvents and catalysts.
The report covers the manufacture and applications of APIs and related pharmaceutical compounds including naproxen, alpha-lipoic acid, azithromycin, ketoprofen, and pregabalin, along with manufacturing processes, plant layout, utilities, safety, location factors, project implementation, and project economics.
Cost Estimation
| Particulars | Value |
|---|---|
| Plant Capacity | 250 Kg./Day |
| Land & Building (3000 sq.mt.) | Rs. 4.06 Cr |
| Plant & Machinery | Rs. 1.15 Cr |
| Working Capital for 2 Months | Rs. 5.30 Cr |
| Total Capital Investment | Rs. 10.80 Cr |
| Rate of Return | 38% |
| Break Even Point | 42% |
Content Index
- INTRODUCTION
- ALPHA-LIPOIC ACID
- AZITHROMYCIN
- KETOPROFEN
- PREGABALIN
- CHEMISTRY AND MANUFACTURERS OF API
- CHEMISTRY
- MANUFACTURERS
- CARBIDOPA API
- DILTIAZEM
- PRECAUTIONS
- GEMFIBROZIL API
- THERAPEUTIC EFFECTS
- PRECAUTIONS AND TOXICITIES
- DRUG INTERACTIONS
- AZITHROMYCIN API
- TREATMENT
- MECHANISM OF ACTION
- SIDE EFFECTS
- ACTIVE PHARMA INGREDIENTS
- APIS ARE GENERALLY MANUFACTURED THROUGH A VARIETY OF PROCESSES THAT INCLUDE:
- MARKET OVERVIEW OF API
- KEY MARKET ANALYSIS
- GLOBAL OVERVIEW OF API
- MARKET OF INDIAN PHARMACEUTICAL INDUSTRY
- COMPOSITION OF INDIAN PHARMA MARKET
- PHARMA EXPORT TO CONTINUE WITNESSING POSITIVE GROWTH
- CHALLENGES FACED BY INDIAN API INDUSTRY
- STRICTER IMPLEMENTATION OF POLLUTION CONTROL NORMS
- INTERPRETATION OF DPCO,
- NO TAX INCENTIVES, HIGHER UTILITIES AND BORROWING COST
- LACK OF MEGA BULK DRUG PARKS
- ISSUES FACED BY FERMENTATION INDUSTRY
- RECOMMENDATIONS
- FASTER ENVIRONMENT CLEARANCE
- ENCOURAGE MANUFACTURING BY PROVIDING A FISCAL STIMULUS FOR APIS AND INTERMEDIATES
- FOR FERMENTATION PRODUCTS
- RECOMMENDATIONS – IMMEDIATE
- ACCOMMODATIVE PRICING POLICY UNDER DPCO,
- FINANCIAL INCENTIVES
- RECOMMENDATIONS – LONG TERM
- INDUSTRY–ACADEMIA INITIATIVES
- FACILITATE ALTERNATIVE SOURCES OF IMPORT
- USES AND APPLICATION OF NAPROXEN
- DOSAGE AND FORM OF NAPROXEN
- MILD TO MODERATE PAIN
- OSTEOARTHRITIS, RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS
- ACUTE GOUT ATTACKS
- JUVENILE RHEUMATOID ARTHRITIS
- HEADACHES
- MANUFACTURING PROCESS OF AZITHROMYCIN
- CHEMICAL REACTION
- MATERIAL OR MASS BALANCE
- MANUFACTURING PROCESS OF PREGABALIN
- STAGE- I
- STAGE-II
- STAGE-III
- PROCESS FLOW DIAGRAM
- MATERIAL BALANCE OF PREGABALIN
- STAGE-I
- STAGE-II
- STAGE-III
- MANUFACTURING PROCESS OF NAPROXEN
- STAGE-I
- STAGE-II
- STAGE-III
- STAGE-IV
- STAGE-V
- STAGE-VI
- STAGE-VII
- PROCESS FLOW DIAGRAM
- RAW MATERIALS
- MANUFACTURING PROCESS OF ALPHA LIPOIC ACID
- STAGE-1
- STAGE-II
- STAGE-III
- MANUFACTURING PROCESS OF KETOPROFEN
- STEP-I
- STEP-II
- OTHER PROCESS OF API MANUFACTURE
- MANUFACTURING PROCESS OF M-BROMO ANISOLE
- REACTION
- PROCESS FLOW DIAGRAM OF M-BROMO ANISOLE
- (BATCH 400 KGS)
- MANUFACTURING PROCESS OF ETHYL TRIPHENYL PHOSPHONIUM BROMIDE (BATCH 135 KG)
- PROCESS FLOW DIAGRAM (BATCH 135 KG)
- MANUFACTURING PROCESS OF CINNAMYLALDEHYDE (BATCH 560 KG)
- PROCESS FLOW DIAGRAM
- MANUFACTURING PROCESS OF M-PHENOXY BENZYL ALCOHOL (BATCH 175 KG)
- PROCESS FLOW DIAGRAM BATCH-175 KG
- MANUFACTURING OF BENZYL ALCOHOL BATCH- 187 KGS
- PROCESS FLOW DIAGRAM
- MATERIAL BALANCE
- DISTILLATORY
- MANUFACTURING PROCESS OF ALPRAZOLAM
- PROCESS FLOW DIAGRAM
- MANUFACTURING PROCESS OF METHYLPHENIDATE
- PROCESS FLOW DIAGRAM
- PRINCIPLES OF PLANT LAYOUT
- STORAGE LAYOUT:
- EQUIPMENT LAYOUT:
- SAFETY:
- PLANT EXPANSION:
- FLOOR SPACE:
- UTILITIES SERVICING:
- BUILDING:
- MATERIAL-HANDLING EQUIPMENT:
- RAILROADS AND ROADS:
- MAJOR PROVISIONS IN ROAD PLANNING FOR MULTIPURPOSE SERVICE ARE:
- PLANT LOCATION FACTORS
- PRIMARY FACTORS
- 1. RAW-MATERIAL SUPPLY:
- 2. MARKETS:
- 3. POWER AND FUEL SUPPLY:
- 4. WATER SUPPLY:
- 5. CLIMATE:
- SPECIFIC FACTORS
- 6. TRANSPORTATION:
- A. AVAILABILITY OF VARIOUS SERVICES AND PROJECTED RATES
- 7. WASTE DISPOSAL:
- 8. LABOR:
- 9. REGULATORY LAWS:
- 10. TAXES:
- 11. SITE CHARACTERISTICS:
- 12. COMMUNITY FACTORS:
- 13. VULNERABILITY TO WARTIME ATTACK:
- 14. FLOOD AND FIRE CONTROL:
- EXPLANATION OF TERMS USED IN THE PROJECT REPORT
- 1. DEPRECIATION:
- 2. FIXED ASSETS:
- 3. WORKING CAPITAL:
- 4. BREAK-EVEN POINT:
- 5. OTHER FIXED EXPENSES:
- 6. MARGIN MONEY:
- 7. TOTAL LOAD:
- 8. LAND AREA/MAN POWER RATIO:
- PROJECT IMPLEMENTATION SCHEDULES
- INTRODUCTION
- PROJECT HANDLING
- PROJECT SCHEDULING
- PROJECT CONSTRUCTION SCHEDULE
- TIME SCHEDULE
- ADDRESSES OF RAW MATERIAL SUPPLIERS
- PLANT AND EQUIPMENT SUPPLIERS
Appendix
- APPENDIX – A:
- 01. PLANT ECONOMICS
- 02. LAND & BUILDING
- 03. PLANT AND MACHINERY
- 04. OTHER FIXED ASSESTS
- 05. FIXED CAPITAL
- 06. RAW MATERIAL
- 07. SALARY AND WAGES
- 08. UTILITIES AND OVERHEADS
- 09. TOTAL WORKING CAPITAL
- 10. TOTAL CAPITAL INVESTMENT
- 11. COST OF PRODUCTION
- 12. TURN OVER/ANNUM
- 13. BREAK EVEN POINT
- 14. RESOURCES FOR FINANCE
- 15. INSTALMENT PAYABLE IN 5 YEARS
- 16. DEPRECIATION CHART FOR 5 YEARS
- 17. PROFIT ANALYSIS FOR 5 YEARS
- 18. PROJECTED BALANCE SHEET FOR (5 YEARS)
Frequently Asked Questions
An active pharmaceutical ingredient (API) is the substance in a pharmaceutical product responsible for producing its intended therapeutic effect.
APIs are manufactured from raw materials using chemical, physical, fermentation, extraction, or other appropriate processing technologies. Depending on molecular complexity, production can involve several reaction and purification stages. The finished API is generally supplied to facilities where it is formulated into products such as tablets, capsules, suspensions, or liquids.
India and China have become major API manufacturing centers because they provide established pharmaceutical manufacturing capabilities and supporting industrial infrastructure.
The concentration of API production in these countries has encouraged pharmaceutical companies to outsource manufacturing. Outsourcing can reduce the need for companies to invest directly in specialized production equipment and infrastructure while allowing them to access established manufacturing capabilities. The report identifies India and China as having some of the greatest concentrations of API manufacturers.
Key environmental considerations include reducing hazardous waste, minimizing solvent consumption, and selecting more environmentally preferable process materials.
API synthesis can generate substantial quantities of waste because of solvents, reagents, catalysts, and multiple reaction stages. The report highlights process simplification as one approach to reducing waste because fewer reactions can require less solvent and generate fewer waste streams. Manufacturers may also evaluate alternative solvents and catalysts that improve process efficiency while reducing environmental impact.
API manufacturers must meet the applicable safety and quality requirements of the markets in which their products will be used.
The report explains that APIs manufactured in countries such as India or China for use in the United States remain subject to applicable U.S. regulatory requirements, including inspection and licensing by the FDA. APIs intended for European markets must meet applicable European regulatory requirements. Regulatory oversight is important for maintaining product quality and addressing concerns such as contamination and counterfeiting throughout international supply chains.
The report covers several pharmaceutical compounds and related API manufacturing processes.
The principal compounds discussed include alpha-lipoic acid, azithromycin, ketoprofen, pregabalin, and naproxen. The contents also cover other APIs and intermediates, including carbidopa, diltiazem, gemfibrozil, m-bromo anisole, ethyl triphenyl phosphonium bromide, cinnamylaldehyde, m-phenoxy benzyl alcohol, benzyl alcohol, alprazolam, and methylphenidate. Process sections include manufacturing stages, reactions, material balances, raw materials, and process flow diagrams where covered by the report.
API plant location should be evaluated using raw-material availability, markets, utilities, transportation, waste disposal, labor, regulations, taxes, and site conditions.
The report divides location considerations into primary and specific factors. These include raw-material supply, markets, power and fuel, water, climate, transportation services, waste disposal, labor availability, regulatory laws, taxes, site characteristics, community factors, vulnerability to wartime attack, and flood and fire control. A suitable site should support safe and reliable operations while providing practical access to required resources and services.
The project report also covers plant design, safety, utilities, location planning, implementation scheduling, suppliers, and project economics.
Its broader project-planning content includes principles of plant layout, storage and equipment layouts, safety, plant expansion, floor space, utilities servicing, buildings, material-handling equipment, roads, and plant location factors. It also addresses project implementation and construction schedules, raw-material suppliers, plant and equipment suppliers, and financial concepts such as depreciation, fixed assets, working capital, break-even point, and capital investment.
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