Active Pharmaceutical Ingredient definition

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”).

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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 means a 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 and 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 a patient receiving the drug product.

Examples of Active Pharmaceutical Ingredient in a sentence

• This protocol describes the experiments to be performed in order to assess the stability of batch 8AG1 of BA058 Active Pharmaceutical Ingredient (API), as produced in the current manufacturing process.

• MOVA shall verify the quantity of each Active Pharmaceutical Ingredient lot, and will release the supplied material based on tests of conformance detailed in the Specifications for Active Pharmaceutical Ingredient approved by DEPOMED.

• All shipments of Active Pharmaceutical Ingredient shall be accompanied by a certificate of analysis from the Active Pharmaceutical Ingredient manufacturer confirming the identity, purity and compliance with the Active Pharmaceutical Ingredient Specifications covering such Active Pharmaceutical Ingredient.

• Elite represents and warrants that it will use commercially reasonable efforts to ensure that any third party supplier of the Active Pharmaceutical Ingredient ("API") for the Product shall have an active Drug Master File with the FDA, shall have been qualified by FDA to supply the API under the ANDA, and is in compliance with the obligations imposed by the FDCA.

• Si un Accord de Qualité n’est pas signé entre les Parties, alors l’annexe « Division of Responsabilities » du « Quality Agreement Template for Generic API’s » tel que publié par l’APIC (Active Pharmaceutical Ingredient Committee) du CEFIC (European Chemical Industry Council) sera applicable par défaut.

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 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.

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.