Bulk Drug definition

Bulk Drug or “BDS” shall mean the active pharmaceutical ingredient of Client Product, in bulk form, and refers to BDS that has been or is to be Produced for Client by ▇▇▇▇▇▇ pursuant to this Agreement. For clarity, the parties agree that the term “Bulk Drug”, when used in the definitions of “Drug Product” and “Finished Product” or when otherwise used for purposes of subsequent Production or Processing of Bulk Drug under this Agreement, refers only to Bulk Drug that both has been Produced for Client by ▇▇▇▇▇▇ pursuant to this Agreement and has not left Althea’s custody or control pending additional Production or Processing (i.e., Bulk Drug that has not been delivered by ▇▇▇▇▇▇ to Client or its designee).

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Bulk Drug. SUBSTANCE shall mean the active ingredients in the Drug Product.

Bulk Drug means the bulk form of the Product which has been manufactured by Lonza pursuant to this Agreement.

Examples of Bulk Drug in a sentence

Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product).
Except as provided in the following sentence, nothing contained in this Article shall be construed to restrict the Parties from disclosing Confidential Information as is reasonably necessary to perform acts expressly permitted by this Agreement or such acts the Parties’ could reasonably expect to be performed in conjunction with the approval and/or manufacture of Bulk Drug Substance and/or any Product.
In the event that Abbott is authorized to utilize a Third Party in the manufacture of Bulk Drug Substance, such Third Party shall be approved by ▇▇▇▇▇▇’▇ Quality Assurance department.
Nycomed will package and label the LX Bulk Drug Substance for shipment in accordance with applicable law and in accordance with Nycomed’s standard practices.
The parties hereto recognize that it is possible for a shipment of Bulk Drug Substance to have Latent Defects.

More Definitions of Bulk Drug

Bulk Drug means any pharmaceutical, chemical, biological or plant product including its salts, esters, stereo-isomers and derivatives, conforming to pharmacopoeial or other standards specified in the Second Schedule to the Drugs and Cosmetics Act, 1940(23 of 1940), and which is used as such or as an ingredient in any formulation;

Bulk Drug means the Drug in bulk form that Cubist or its Bulk Drug suppliers shall deliver to Abbott for incorporation into Product and meeting the applicable Bulk Drug Specifications.

Bulk Drug. SUBSTANCE shall mean the active compound, as set forth in the Project Plan, to be supplied by CLIENT for use in Production of Drug Product.

Bulk Drug. [Lisuride]

Bulk Drug means the bulk form of the Product which has been manufactured --------- by Genentech pursuant to this Agreement, which has been purified to a concentrated form from one or more Batches and can be stored in a liquid or frozen form under appropriate conditions, and, except with respect to Non-Conforming Bulk Drug, which has been manufactured in compliance with cGMP and conforms to the Bulk Drug Specifications.

Bulk Drug means the bulk form of API.

Bulk Drug means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.