Finished Drug Product definition

Finished Drug Product means any drug product containing API as an active ingredient in finished bulk form for the Development or Commercialization by a Party under this Agreement.

Finished Drug Product means the finished product formulation of a Licensed Product, containing API Bulk Drug Substance, filled into unit packages for final labeling and packaging, and as finally labeled and packaged in a form ready for administration.

Finished Drug Product means that term as defined in 21 CFR 207.1.

Examples of Finished Drug Product in a sentence

• Within [***] days from the Effective Date, the Parties will discuss and mutually agree through the CSC, on an initial manufacturing technology transition strategy to transition API and Finished Drug Product Manufacturing for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx to [***] as the case may be.

• Subject to the terms and conditions of this Agreement, Akcea hereby grants Novartis, a worldwide, non-exclusive, sublicensable (but only by Novartis to a Novartis Affiliate or a CMO), royalty-free license under the Licensed Technology solely to conduct during the Option Period the manufacturing and manufacturing transition activities contemplated by this Section 1.3.2 to manufacture API and Finished Drug Product for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx.

• Pending Processing of the Drug Substance into Finished Drug Product, Amgen shall store such Drug Substance on behalf of Company in accordance with the Specifications.

• In furtherance of such plan, the Parties agree that Novartis may enter into contractual arrangements (each, a * ***Confidential Treatment Requested “CMO Agreement”) with one or more CMOs to manufacture clinical supplies for Phase 3 Trials and commercial supply of API and Finished Drug Product.

• NB: It should be noted that all stages of manufacture from API to bulk vials of Finished Drug Product are manufactured under the direct control of GW with all but one activities being carried out on the same site.

More Definitions of Finished Drug Product

Finished Drug Product means a drug that is legally marketed under the federal food, drug, and cosmetic act and that is in finished dosage form.

Finished Drug Product means the Drug Product finally labelled and packaged for end-user use, as required for a Trial or for Commercialization, as applicable.

Finished Drug Product means a drug legally marketed under the Federal Food, Drug, and Cosmetic Act, which is in finished dosage form.

Finished Drug Product means Drug Substance that has been Processed by Amgen pursuant to this Supply Agreement and that meets the Specifications.

Finished Drug Product means a drug legally marketed under the Federal Food, Drug, and Cosmetic Act that is in finished dosage form. For purposes of this paragraph, the term “drug” has the same meaning as provided in s. 499.003(17).

Finished Drug Product means a drug legally marketed under the federal food, drug, and cosmetic act, 21 U.S.C. 321 et seq., that is in finished dosage form.

Finished Drug Product means any medicinal product manufactured by Buyer and containing the Product, manufactured by [*], as an active ingredient. GMP (Good Manufacturing Practices or Current Good Manufacturing Practices): Shall mean Good Manufacturing Practices requirements from time to time promulgated by Regulatory Authority, including the practices set out in the Guidelines published as the Good Manufacturing Practices by the drug authority(ies) in the Territory, as amended from time to time, for the manufacture of pharmaceutical Products for sale in the Territory.