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”).

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, 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

• DEFINITIONS - RESPONSE FIELDS The table is for reference when completing the Bid Response Document Response FieldDescriptionEstimateEstimated quantities of units the Department will need over the contract periodDelivered PriceFinal price offered by a supplier for a line item which includes VAT anddelivery.API Cost %The cost of Active Pharmaceutical Ingredient as a percentage of thedelivered price.

• New Chemical EntityA chemical or biologically Active Pharmaceutical Ingredient (API) that has not previously been registered as an ingredient of any pharmaceutical product.

• DEFINITIONS - RESPONSE FIELDS The table is for reference when completing the Bid Response Document Response FieldDescriptionEstimateEstimated quantities of units the Department will need over the contract periodDelivered PriceFinal price offered by a supplier for a line item which includes VAT and delivery.API Cost %The cost of Active Pharmaceutical Ingredient as a percentage of thedelivered price.

• The DMF will then undergo an initial completeness assessment, using factors articulated in the final guidance Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments.

• The Research and Development wing in the Active Pharmaceutical Ingredient department of Bal Pharma Limited has stayed its course on developing new and economical methods for products possessing medicinal properties.

More Definitions of Active Pharmaceutical Ingredient

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 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 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 means a compound, whether naturally occurring, chemically synthesized, or biologically produced, that is regulated as a drug by the FDA.

Active Pharmaceutical Ingredient or “API” means the material listed on Schedule D;

Active Pharmaceutical Ingredient or “API” means the active pharmaceutical ingredient for Product.