ACTIVE PHARMA INGREDIENTS (API)

The project report includes Present Market Position and Expected Future Demand, Market Size, Statistics, Trends, SWOT Analysis and Forecasts. Report provides a comprehensive analysis from industry covering detailed reporting and evaluates the position of the industry by providing insights to the SWOT analysis of the industry.

We can prepare PROJECT REPORT as per your INVESTMENT PLAN for BANK LOAN REQUIREMENT and INDUSTRY ANALYSIS. All reports are prepared by highly qualified consultants and verified by a panel of experts.

Have Query? Click Here to Chat
Industry Expert is Online, Chat with him for more detail.

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.

Description

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)

Additional information

Plant Capacity

1592 Kg./Day

Land & Building

(6000 sq.mt.)

Plant & Machinery

US$ 157142

Rate of Return

43%

Break Even Point

45%