Finished Drug Product means any drug product containing API as an active ingredient, in finished form for Development or Commercialization by a Party under this Agreement.
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.
Examples of Finished Drug Product in a sentence
In furtherance of such plan, the Parties agree that Novartis may enter into contractual arrangements (each, a * ***Confidential Treatment Requested 9 “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 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 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 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, 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.