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

Examples of Finished Drug Product in a sentence

• 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.

• When requested, advise the 1 SOW/CC or CP of the most suitable aircraft refuge.

• We introduce various filtering methods and investigate how this affects the resolution.

• A period of time from the Effective Date until ten (10) years after the Finished Drug Product is launched in the Territory.

• 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.

More Definitions of Finished Drug Product

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

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 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 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, 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.

Finished Drug Product means a final dosage form containing the API that is labeled and packaged as approved by a Regulatory Authority. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.