WHAT DO YOU UNDERSTAND BY API PRODUCTION INDUSTRY?

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API Production industry refers to the organ by which raw materials are converted into active pharmaceutical ingredients through physical and chemical means.

 

The process of manufacturing these APIs depend on the production company.
Who are top players in the API production Industry?

There are several recognized API production companies. Among those top in the list include:

  • API (Teva Active pharmaceutical ingredients)- This is among the most popular API production companies, specializing in a range of API related fields.

It specializes in processes of production such as fermentation, chemical synthesis, chromatography as well as plant extraction.

  • Dr. Eddy’s – This is another leading manufacturer. It produces about 60 APIs for a variety of uses such as diagnostic kits, biotechnology products and drug use.
  • AUROBINDO- produces about 200 APLs. This API production company is responsible for export of this products to over 200 countries.
  • CIPLA- are also responsible for producing approximately 200 APLs. They also export these products to about 200 countries.

What are the regulation safeguarding manufacture of APIs?

These are strict quality and safety standards set by each country regarding the manufacture of APIs. A good for example would be API manufactured in India and china and exported for use in the U.S.A. They have to be inspected by the FDA first. Similarly, those intended for the use in Europe have to meet standards set by the European countries’ agencies.

To ensure APIs are properly inspected authorities such as the FDA increase staff working overseas. This is aimed especially at countering contamination and counterfeiting that has been on the rise.

API Production companies have also been urged continuously to ‘go green’. This simply means they should strive to reduce the amount of waste they produce. No wonder new API production companies are advancing more environment friendly methods of production.

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