What are APIs (Active Pharmaceutical Ingredients)?

 

People take medicines to cure, diagnose, treat, or prevent a disease. Most medication contains a couple of ingredients. The most important one is the API, which stands for Active Pharmaceutical Ingredient. This is the actual substance in the medicine that has to do the work in your body.

For example, the API in Aspirin is “acetylsalicylic acid“. This API will try to fight the pain of your fever or headache. Some medicines carry the name of the API. For instance, the API of Paracetamol is “paracetamol“. To make a pill, you’ll need more ingredients than just the API. That’s where excipients come in. These ingredients are used to give the pill, for example, volume, a sweet flavor, or a color.

The term API is not only used in the pharmaceutical industry, but also in the web developers community the term API is common. For them however, it stands for “Application Programming Interface“.

other examples are:

1. ANALGESIC :  aceclofenac, diclofenac potassium, diclofenac sodium, paracetamol
2. ANTIHISTAMINE : diphenhydramine HCL, montelukast sodium
3. ANTI-DIABETIC : glimepiride, metformin hydrochloride
4. ANTI-HYPERTENSIVE : amlodipine besylate, telmesartan

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. They could also be inspected by foreign government instances and third party companies do audits at 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, every batch of produced API is also analysed by laboratories, depending on the situation it is even possible that one specific batch is analysed 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.