The chemical component of a drug treatment that is biologically active.
In addition to an API, drug formulations may include a range of other biologically inactive materials, for example, to promote stability or to facilitate the manufacture of tablets or liquid medicines.
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry (FDA, 2020)
ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers (EMA, 2015)
Definition of Active Pharmaceutical Ingredient (WHO, 2011)
Compliance Program Guidance Manual – Active Pharmaceutical Ingredient (API) Process Inspection (FDA, 2015)