What Are APIs (Active Pharmaceutical Ingredients)? Insights by Pharmaoffer

Quality of APIs (active pharmaceutical ingredients)

Medication is, of course, intended to help people. So, we need to know the ingredients, such as the API, are safe to use. 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 the European Medicines Agency, and those sold in the US need to meet the regulations issued by the U.S. Food and Drug Administration (FDA).

Companies in the entire API supply chain get inspected by their local government. Foreign governments instances could also inspect them, and third-party companies do audits of each other companies.

When everything is up to code, companies are given a certain certificate, such as GMP or a written confirmation, so other professionals in the industry know that that specific company complies with the industry standards without them having to inspect or audit themselves. When the inspection fails, the companies will be issued a warning, and pharmaceutical buyers won’t be able to buy there until the issues are resolved and the company is re-inspected.

Not only the factory or production facility is inspected, but laboratories also analyze every batch of produced API; depending on the situation, it is even possible that one specific batch is analyzed multiple times: For example, by the company that produced it, by a 3rd party laboratory, by the trader who buys it, and by the hospital that will use it.

The difference between QA and QC

Also, every pharmaceutical company has an entire team dedicated to quality assurance and quality control. This team can consist of pharmacists, chemists, biologists and other trained and qualified personnel. You could say that the first team, quality assurance, ensures everything is fine before the production process starts, while quality control ensures everything is performed according to plan.

Nonproprietary names: USAN/INN

While the number of available prescription or over-the-counter drugs (OTC) under different names increases daily, the situation differs in the case of APIs. Considering how expensive the steps to introducing a new drug to the market are, there isn’t a great number of new APIs being introduced. An API is sold under only one name: the nonproprietary name.

To avoid confusion in this market, which potentially would have dangerous consequences, WHO, in cooperation with national drug safety agencies worldwide, came up with a list of non-proprietary names back in 1953. The organization revises the list regularly, and you can send them a request for 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 must put the API name right under the brand name.