Finished Manufacture definition

Finished Manufacture means the manufacture of Finished Product from Compound or Drug Product, as the case may be.
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Finished Manufacture means the manufacture (and all reasonably necessary testing, including release and, as appropriate, stability testing) of Finished Product from Bulk API.
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Finished Manufacture means all activities related to the formulation and filling of API (but excluding any Packaging activities) into Drug Product form suitable for use in Clinical Trials or Commercialization (i.e., bottles or blisters), in accordance with Applicable Laws.
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Examples of Finished Manufacture in a sentence

  • Rhizen shall be responsible for the Finished Manufacture, testing (including stability testing) and final release of the Finished Product for Commercialization in the Territory.

  • PI: Carlos Galindo; Co-PIs: Andrea Arce-Trigatti, Stephanie Jorgensen.

  • Product Development under the GDP or the Finished Manufacture of the Finished Product, and shall ensure that such Affiliates, Sublicensees, and subcontractors permit such inspections.


More Definitions of Finished Manufacture

Finished Manufacture means the manufacture of Finished Product from Bulk Hematide.
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Finished Manufacture means the manufacture of Finished Product from Drug Product.
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Related to Finished Manufacture

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

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

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

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

  • API means American Petroleum Institute.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Process means any process for—

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Distillery manufacturing license means a license issued in accordance with

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices (cGMP) and all applicable governmental rules and regulations as applied at the site(s) of manufacture and control, as amended from time to time and in effect during the term of this License Agreement.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

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

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Raw Materials means all raw materials, supplies, components and packaging necessary to manufacture and ship the Product in accordance with the Specifications, as provided in Exhibit A, but not including the API.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • Date of manufacture means the date on which the food becomes the product as described;

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.