api drug definition
API (Active Pharmaceutical Ingredient) is 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. An Active Pharmaceutical Ingredients or API is the ingredient in a finished drug that has the intended therapeutic effect. FDA regulates APIs as drugs because they are drug components. FDA also regulates inactive drug ingredients, but with far less focus or stringency. An Active Pharmaceutical Ingredients or API is the ingredient in a finished drug that has the intended therapeutic effect. FDA regulates APIs as drugs because they are drug components. Definition: API (Active Pharmaceutical Ingredient) refers to a substance or substance combination used in manufacturing a drug product. API also refers to the active or central ingredient in the product which causes the direct effect on the disease diagnosis, prevention, treatment or cure. 1 Active Pharmaceutical Ingredient: Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. API (Active Pharmaceutical Ingredient) refers to a substance or substance combination used in manufacturing a drug product. API also refers to the active or central ingredient in the product which causes the direct effect on the disease diagnosis, prevention, treatment or cure. While API is the active component of a drug, excipients are the inactive or inert substances present in a drug. An API starting material, usually a defined chemical property purchased in the market place or produced in-house, is used in the production of an API. API also refers to the active or central ingredient in the product which causes the direct effect on the disease diagnosis, prevention, treatment or cure. While API is the active component of a drug, excipients are the inactive or inert substances present in a drug. The U.S. Food and Drug Administration defines an APIs as. any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. An API process is a related series of operations which result in the preparation of an active pharmaceutical ingredient. Major operations or steps in an API process may include multi-step chemical synthesis and fermentation, purification, crystallization, drying, milling, packing, labeling, and testing.
The ingredient in a finished drug that has the intended therapeutic effect.