Active Pharmaceutical Ingredient (API) definition

Active Pharmaceutical Ingredient (API) has the meaning set forth in the Quality Agreement.
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Active Pharmaceutical Ingredient (API) means active pharmaceutical ingredient 5- aminolevulinic acid hydrochloride.
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Active Pharmaceutical Ingredient (API) means the active ingredient of the Intermediate(s) and/or Product(s).
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Examples of Active Pharmaceutical Ingredient (API) 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.

  • 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.

  • Prior to her current role, ▇▇▇▇▇ was vice president, Quality, for ▇▇▇▇▇’▇ Active Pharmaceutical Ingredient (API) manufacturing network, Puerto Rico manufacturing, and Product Research and Development.

  • Managing Chemistry, Manufacturing, and Controls development capabilities (crystallization, form selection, method development, solubility, formulation) and Active Pharmaceutical Ingredient (API) scale up (including shipping and receiving).

  • InveniAI and Relief desire to initiate a strategic collaboration, wherein InveniAI will use its Platform to help navigate the volume of data for all regulatory agency approved drugs and their associated active ingredients (Active Pharmaceutical Ingredient (API)) and associate to potential rare disease indications, “API-disease combinations” for IND-enabling, development and commercialization by Relief (“Product Concepts”).

  • Raw Materials means the materials used in the Production of the Product that may become part of the finished Product such as Active Pharmaceutical Ingredient (API), excipients, and buffer components.

  • The return or destruction of Active Pharmaceutical Ingredient (API) will be specified within the Study Protocol.

  • Each FPP must be identified by the International Non-proprietary Name (INN) thus:  The Active Pharmaceutical Ingredient (API) base or the prodrug compound, salt or ester, as applicable.

  • Bulk Drug Substance or Active Pharmaceutical Ingredient (API) shall mean the un-formulated Bulk Drug Substance or Active Pharmaceutical Ingredient used as starting material, delivered by CLIENT (at its cost), to HYALURON for formulating and processing.

  • Pharmaceutical Adaptation of a licensed preparations medicinal product Active Pharmaceutical Ingredient (API) into three different types: reconstitution in excess of SmPC preparation instructions, adaptation of a licensed medicinal product, and medicinal product from an active pharmaceutical ingredient.


More Definitions of Active Pharmaceutical Ingredient (API)

Active Pharmaceutical Ingredient (API) means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient);
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Active Pharmaceutical Ingredient (API) means any substance or combination of substances used in a finished pharmaceutical product, intended to furnish 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.
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Active Pharmaceutical Ingredient (API) means the active ingredient [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].
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Active Pharmaceutical Ingredient (API) means a nonrebatable bulk drug substance, defined in 21 CFR 207.3(a)(4) (2011) as any substance that is represented for use in a drug and that, when used in manufacturing, processing, or packaging of a drug, becomes an active ingredient of the drug product.
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Related to Active Pharmaceutical Ingredient (API)

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).