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Active Pharmaceutical Ingredient

An API also called Drug Substance (DS) is any physiologically active substance that is intended for use in a Drug Product. An API is also a substance when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished Dosage Form of the Drug.

or

Any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body of humans or other animals. APIs include substances manufactured by processes such as chemical synthesis; fermentation; recombinant DNA or other biotechnology methods; isolation/recovery from natural sources; or any combination of these processes.