Detailed Project Report (DPR) on active pharma ingredients (api)

ACTIVE PHARMA INGREDIENTS (API)

[CODE NO.4120] 

The Active Pharmaceutical Ingredient Industry is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means. Depending on the complexity of the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of processing technologies.

The leading manufacturer of APIs today is TAPI (Teva Active Pharmaceutical Ingredients). Specializing in range of API-related fields, TAPI works in areas such as chemical synthesis, fermentation, and chromatography and plant extraction and now has the industry’s largest portfolio of over 300 API products.  In 2011 alone they achieved third-party sales of around $750 million.

Dr. Reddy’s is another leading manufacturer with 60 APIs for drug use, diagnostic kits and biotechnology products. Aurobindo and Cipla manufacture 200 APIs each, exporting their products to well over 200 countries worldwide. Other notable manufacturers are Sandoz-Lek-Biochemie, Ranbaxy, Matrix and Sun.

APIs are commonly referred to as ‘bulk pharmaceuticals’ and are in fact usually made in places at quite a distance to where tablets, suspensions and liquids are manufactured. Today, the greatest concentrations of API manufacturers are located around Asia, specifically in India and China. This has led to more and more companies to outsource API manufacturing to such places, which has the main benefit of eliminating the need to invest in highly expensive equipment and infrastructure – which on top of everything can also be complicated to install and maintain. A good example can be found with AstraZeneca, who manufacture 85% of its APIs but are currently in the process of withdrawing from all API production in favor of outsourcing.

Regardless of where the active pharmaceutical ingredient is made, companies must adhere to strict safety and quality standards set by the country where it will be used. So those APIs manufactured in China or India for use in the United States must still be inspected and licensed by the FDA. Similarly, if the API is intended for use in Europe, they would need to meet regulations set by the European Medicines Agency. Regular inspection outside the country of use however can prove difficult with counterfeiting and contamination being high on the list of various agencies’ concerns. For instance, since 2008, the FDA has considerably increased its overseas staff as a way of attempting to eliminate these problems. As a result, countries such as India have gained their foothold in the global market and now have around 75 FDA-approved manufacturing facilities for API synthesis.

Today there are more and more calls for API manufacturers to go green – that is to say, to reduce the waste they produce. Every year, large pharmaceutical manufacturers can produce anywhere from 3000 to 5000 tons of hazardous waste each.  If one were to ask any reputable API manufacturer how they would like to improve the process, they’d likely say to make the reactions faster, or to make them cheaper. Ironically the first steps in reducing waste from API synthesis would be to reduce the number of reactions required to produce a given molecule.  Therefore though the goal may be different, the means turn out to be the same as fewer reactions mean less solvent to dispose of. Another step in going green is to find different solvents and catalysts that are not only more efficient, but are also better for the environment.

COST ESTIMATION

Plant Capacity                                 1592 Kg./Day

Land & Building (6000 sq.mt.)       Rs. 3.41 Cr

Plant & Machinery                            Rs. 1.10 Cr

Working Capital for 1 Month        Rs. 3.30 Cr

Total Capital Investment                Rs. 7.99 Cr

Rate of Return                                 43%

Break Even Point                            45%

• INTRODUCTION
• CHEMISTRY AND MANUFACTURERS OF API
• CHEMISTRY
• MANUFACTURERS
• CARBIDOPA API
• DILTIAZEM
• THERAPEUTIC EFFECTS
• AZITHROMYCIN API
• TREATMENT
• MECHANISM OF ACTION
• SIDE EFFECTS
• ACTIVE PHARMA INGREDIENTS
• 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
• INDIAN API MANUFACTURERS LOST THEIR COMPETITIVE EDGE 
• IN THE MANUFACTURE OF APIS AT THE LOWER END OF THE SPECTRUM AND FERMENTATION TECHNOLOGIES.
• STRICTER IMPLEMENTATION OF POLLUTION CONTROL NORMS
• INTERPRETATION OF DPCO, 2013
• 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
• FINANCIAL INCENTIVES
• RECOMMENDATIONS – LONG TERM
• INDUSTRY–ACADEMIA INITIATIVES
• FACILITATE ALTERNATIVE SOURCES OF IMPORT
• MANUFACTURING PROCESSES OF API
• MANUFACTURING PROCESS OF M-BROMO ANISOLE
• PROCESS FLOW DIAGRAM OF M-BROMO ANISOLE
• MANUFACTURING PROCESS OF ETHYL TRIPHENYL PHOSPHONIUM BROMIDE
• 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
• MANUFACTURING OF BENZYL ALCOHOL BATCH- 187 KGS
• PROCESS FLOW DIAGRAM
• MANUFACTURING PROCESS OF ALPRAZOLAM
• PROCESS FLOW DIAGRAM
• MANUFACTURING PROCESS OF METHYLPHENIDATE
• PROCESS FLOW DIAGRAM
• ADDRESSES OF RAW MATERIAL SUPPLIERS
• PLANT AND EQUIPMENT SUPPLIERS

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)