Active Pharmaceutical Ingredient definition

Active Pharmaceutical Ingredient or “API” means the active pharmaceutical or biological ingredient as further set forth in the applicable Product Manufacturing Plan.
Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).
Active Pharmaceutical Ingredient means, in a pharmaceutical product, a clinically active material that provides pharmacological activity (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

Examples of Active Pharmaceutical Ingredient in a sentence

  • For medicines in Document No 05b, Sheet 2, Medication Catalogue where the Authority is considering splitting the award between multiple Suppliers, in addition to the evaluation described in 4.4.20 the Authority will seek further supply chain assurance by selecting the combination of Suppliers that have independent Intermediate and Active Pharmaceutical Ingredient (API) sources.


More Definitions of Active Pharmaceutical Ingredient

Active Pharmaceutical Ingredient means any substance which can be used in a pharmaceutical formulation with the intention to provide pharmacological activity; or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease; or to have direct effect in restoring, correcting or modifying physiological functions in human beings or animals;
Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.
Active Pharmaceutical Ingredient or “API” shall mean bulk supplies of the pharmacologically active compound(s) comprising Product and listed in each Attachment “A#.3,” (i.e., A1.3) which Customer will provide to BVL in bulk form, from time to time, for the sole purpose of development and Manufacture of Product for Customer.
Active Pharmaceutical Ingredient or “API” means any substance or mixture of substances intended to be used in the compounding of a drug preparation and that, when used in the compounding of a drug preparation, becomes an active ingredient in the preparation intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease in humans and animals or affecting the structure and function of the body.
Active Pharmaceutical Ingredient or “API” means the material listed on Schedule D;
Active Pharmaceutical Ingredient or “API” means the active pharmaceutical ingredient for Product.
Active Pharmaceutical Ingredient or “API” means any substance intended to be used in a pharmaceutical product that when used becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions in man or animal; but excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies.