Final Drug Product definition

Final Drug Product means Drug Product in the ready-to-sell form provided that a marketing authorization has been obtained for such pharmaceutical product from the U.S. Food and Drug Administration (FDA) or any other competent regulatory authority in the world.
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Final Drug Product. A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.
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Final Drug Product or "FDP" shall mean PRODUCT packaged into its final dosage form (liquid or lyophilized product in vials).
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Examples of Final Drug Product in a sentence

  • The EU defines Final Drug Product Lot Release Testing as typically including endotoxin, sterility, analytical assays and potency testing.

  • The final product is supplied in up to three 200 mL bags, containing a dose of ≥ 5,000 IEq/kg recipient body weight for the first transplant, and ≥ 4,000 IEq/kg recipient BW for subsequent transplants.Table 5 Composition of Final Drug Product [Product Code PHPI-A-01] Administration:The islet mixture is delivered slowly via gravity drainage from a bag attached to the catheter in the portal vein or portal vein tributary.

  • TMC avers that Mylan’s ANDA No. 202471 infringes certain claims of the patents-in-suit.I. Bivalirudin Final Drug Product There are two main steps in making the bivalirudin final drug product.

  • C.3.1.1 The contractor shall complete all scope required for the production, release and delivery use of 100 million Final Drug Product (FDP) doses of a SARS-CoV-2 mRNA-1273 vaccine.

  • The final product is supplied in up to three 200 mL Ricordi® bags, containing a dose of ≥ 5,000 IEq/kg recipient body weight for the first transplant, and ≥ 4,000 IEq/kg recipient BW for subsequent transplants.Table 5 Composition of Final Drug Product [Product Code PHPI-A-01] Administration:The islet mixture is delivered slowly via gravity drainage from a bag attached to the catheter in the portal vein or portal vein tributary.

  • Lifecore will be responsible for compliance with all applicable FDA and EMA requirements for the manufacture of the Finished Final Drug Product, Final Drug Product, and Intermediate Drug Product, and for the performance of services on the behalf of Heron under this Agreement; provided that Heron willreimburse Lifecore for the EMA audit and certification costs at the rates set forth in Exhibit B, and provided that Lifecore shall inform Heron of the anticipated costs in advance of incurring them.

  • Investigators assigned to federal or local CST authorities or special inspectors of the MoCST are responsible for copyright infringement cases and copyright disputes.

  • All Prices exclude VAT, federal, state or local taxes which are properly attributable to the Finished Final Drug Product and which will be added to the Price or billed separately to Heron where Lifecore has the legal obligation to collect the taxes or fees, and all expenses related to shipping, insurance, handling, storage, and customs duties and fees.

  • Heron will provide shipping instructions for Finished Final Drug Product.

  • Subject to the terms of this Agreement, Lifecore will supply, in each calendar quarter, Finished Final Drug Product in quantities sufficient to fulfill all Firm Purchase Orders placed by Heron up to [*********] of the Binding Forecast.


More Definitions of Final Drug Product

Final Drug Product or “FDP” means [*********].
Sample 1
Final Drug Product means any form of the vaccine, which can be sold to the final market, and which may comprise, among others, primary or secondary container or formulation forms or components, water-for-injection to reconstitute the vaccine, user information leaflet, blister packaging, paper box and country-specific packaging identification features.
Sample 1
Final Drug Product means any form of the vaccine, which can be sold to the final market, and which may comprise, among others, primary or secondary container or formulation forms or components, water-for-injection to reconstitute the vaccine, user information leaflet, blister packaging, paper box and country-specific packaging identification features.
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Related to Final Drug Product

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • FDA means the United States Food and Drug Administration.

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.