Common use of Active Pharmaceutical Ingredient Clause in Contracts

Active Pharmaceutical Ingredient. (API),—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 as defined in ICH Q 7. Such substances are intended to furnish pharmacological activity or other direct effect on the diagnosis, cure mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Active Pharmaceutical Ingredient. (API),—Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinalAPI) product and that, when used in the production of a drug, becomes an active ingredient of the Drug Product as defined in ICH Q 7. Such substances are – any component that is intended to furnish pharmacological activity or other direct effect on in the diagnosis, cure cure, mitigation, treatment, treatment or prevention of disease disease, or to affect the structure and or any function of the bodybody of humans or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.