Every year, large pharmaceutical manufacturers can produce anywhere from 3000 to 5000 tons of hazardous waste each. Today there are more and more calls for API manufacturers to go green – that is to say, to reduce the waste they produce. 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. For instance, since 2008, the FDA has considerably increased its overseas staff as a way of attempting to eliminate these problems. Regular inspection outside the country of use however can prove difficult with counterfeiting and contamination being high on the list of various agencies’ concerns. Similarly, if the API is intended for use in Europe, they would need to meet regulations set by the European Medicines Agency. So those APIs manufactured in China or India for use in the United States must still be inspected and licensed by the FDA. 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. 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.
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. Today, the greatest concentrations of API manufacturers are located around Asia, specifically in India and China. Other notable manufacturers are Sandoz-Lek-Biochemie, Ranbaxy, Matrix and Sun.ĪPIs 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. Aurobindo and Cipla manufacture 200 APIs each, exporting their products to well over 200 countries worldwide.
Reddy’s is another leading manufacturer with 60 APIs for drug use, diagnostic kits and biotechnology products.
In 2011 alone they achieved third-party sales of around $750 million.ĭr. Specializing in range of API-related fields, TAPI works in areas such as chemical synthesis, fermentation, chromatography and plant extraction and now has the industry’s largest portfolio of over 300 API products. The leading manufacturer of APIs today is TAPI (Teva Active Pharmaceutical Ingredients). Depending on the complexity of the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of processing technologies. The Active Pharmaceutical Ingredient Industry is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means.