Posted on April 11, 2019
What are APIs (Active Pharmaceutical Ingredients)?
Medicines, no matter if it comes as a liquid, powder or in a solid form it's comprised of two main components: Active Pharmaceutical Ingredient (API) and Excipient.
Defining the API precisely is not an easy task- different interpretations sometimes arise complex legal issues. However, FDA and WHO rely on a virtually identical definition of APIs, essentially defining them as the part of drug responsible for therapeutic effects.
Excipients are the inactive ingredients which are used as fillers/binders/coatings of the medicine.
APIs, Bulk Pharmaceuticals and their importance to the pharma industry
The term API is not only used in the pharmaceutical industry, but also web developers are speaking about an API, Application Programming Interface. So, make sure you're not joining the wrong forum or hiring the wrong specialist.
APIs are most often made in a powder form and then sold in large quantities to drug manufacturers. Global leaders in the API supply are India and China. To cut the expenses, API manufacturers from Western Europe and the US in the last couple of decades moved their production lines towards Asia.
No matter where an API is produced, it has to meet the safety and quality criteria of the country where end users are located. That means, drugs sold in the EU need to meet the strict safety and quality standards of European Medicines Agency and those sold in the US need to meet the regulations issued by the U.S. Food and Drug Administration (FDA).
Nonproprietary names- USAN/INN
While the number of available prescription or over the counter drugs under different names increases daily, the situation is a bit different in case of APIs. Having in mind how expensive the steps to introducing a new drug to the market are, APIs do not show up as fast. Also, there is a rigorous rule on the market of APIs- one API is sold under only one name- a nonproprietary name.
To avoid a dangerous confusion on this market, WHO in cooperation with national drug safety agencies from all over the world came up with a list of nonproprietary names back in 1953. The organization revises the list regularly and you can send them a request for a new International Nonproprietary Names (INN).
So, everywhere in the world, Ramipril is sold as Ramipril, and that API can’t be bought under any other name.
Drug manufacturers can sell their drugs under any name they want, but they need to put the API name right under the brand name.
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