As defined by USFDA active Pharmaceutical Ingredients (API’s) are ‘’any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in the production of a drug becomes an active ingredient of the drug product’. These are also known as ‘bulk drug substances’. Basically drug manufacturers use API’s as a source material for manufacturing of drug products. As a part of Good Manufacturing Practice (GMP) pharmaceutical companies also use API’s at different stages of drug development such as stability sample testing, general analytical testing and method development and clinical trials.

Owing to patent expiry of many blockbuster drugs starting from 2011 to 2019 big pharma companies are eying for low cost suppliers for API’s. To achieve this objective many pharma companies are expected to outsource their in house API production to low cost manufacturing locations such as India and China. Emphasis on high potential API’s is increasing due to cost containment and this is likely to create opportunities for biosimilars and generic markets.

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