API (active pharmaceutical ingredient) definition
API (active pharmaceutical ingredient) means any substance or mixture of substances intended to be used in the manufacture of drug product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacologic 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.
API (active pharmaceutical ingredient) means any Fenfluramine Hydrochloride substance to be used in the manufacture of the Product.