Active Pharmaceutical Ingredient - API

An active Pharmaceutical Ingredient (API) is the biologically active component of a drug product that produces a pharmacological effect. It is the chemical substance responsible for a drug's therapeutic activity. APIs are usually synthesized through chemical reactions or extracted from natural sources such as plants, animals, or microorganisms.

The API is a key component of a drug product, and it must be of high quality, purity, and potency to ensure the safety and efficacy of the drug. The quality of an API is regulated by the relevant regulatory authorities in the country where it will be used. The regulatory authorities require that the API be characterized and tested to ensure that it meets certain specifications for quality, purity, and potency.

Once the API is manufactured, it is usually formulated into a drug product, a finished dosage form suitable for administration to patients. The drug product may contain other ingredients such as excipients, fillers, and binders, which are added to improve the drug's stability, bioavailability, and other properties.