The Importance of APIs in Pharmaceutical Manufacturing
What is an API?
An active pharmaceutical ingredient (API) is the chemical or biological compound responsible for the therapeutic effect of a medication. It is the active ingredient in both over-the-counter (OTC) and prescription drugs.
Components of an API
An API typically consists of the drug substance itself and excipients, which are inactive ingredients that help to deliver the drug to the body.
Where are APIs Manufactured?
APIs are primarily manufactured in a few countries, including the USA, Europe, China, and India.
Prequalification of APIs
The World Health Organization (WHO) has established a prequalification program to identify APIs that meet good quality standards and are manufactured in compliance with WHO guidelines.
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