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 Xxxxxx 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 Xxxxxx 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 Xxxxxx to Client or its designee).
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Bulk Drug. SUBSTANCE shall mean the active ingredients in the Drug Product.
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Bulk Drug means the bulk form of the Product which has been manufactured by Lonza pursuant to this Agreement.
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Examples of Bulk Drug in a sentence

  • USP also notes that it plays no role in enforcement and that regulators continue to have the authority to make their own determinations regarding enforceability of Chapter <800>.FDA Issues Statement on Compounded Bulk Drug Substances RulingA US district court judge in Washington, DC, recently upheld Food and Drug Administration’s (FDA’s) interpre- tation of clinical need regarding bulk substances that may be used by outsourcing facilities in drug compounding.

  • The Evaluation Framework, similar to the Planning Framework, depends on data that accurately measures Rural Generalists and their scope of practice, alongside other rural workforce, and links this with other data from rural health services and rural communities.

  • For proposed policies pertaining to compounding drug products from bulk drug substances for use in animals, see FDA’s draft guidance, Compounding Animal Drugs from Bulk Drug Substances.All FDA guidances are available on the FDA guidance web page.

  • In the Commercial Supply Agreement, the Parties shall determine the percentage of the Net Sales Price(s) for Drug Product(s) that shall be attributed to the price for Bulk Drug Substance supplied by VERTEX for the manufacture of such Drug Product(s) sold in the Territory.

  • VERTEX, its Affiliates or VERTEX Licensees will be the principal contact for and will otherwise take the lead role in all interactions with Regulatory Authorities concerning Bulk Drug Substance or a Drug Product in the VERTEX Territory.


More Definitions of Bulk Drug

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.
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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;
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Bulk Drug means any substance including pharmaceutical, chemical, biological or plant product or medicinal gas conforming to pharmacopoeial or other standards accepted under the Drugs and Cosmetics Act, i940 (23 of 1940), which is used as such or as an ingredient in any formulations;
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Bulk Drug means the bulk form of the Product which has been manufactured
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Bulk Drug means the bulk form of API.
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Bulk Drug. [Lisuride] Price Per Total Quantity of Total Unit Number of Drug Quantity of Bulk Total Shipping Doses per Dose of Bulk Drug Drug(1) Price Terms Pxxxx 0 Xxxxx 0 Xxxxx 0 Xxxxx 4
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Bulk Drug means Dapsone.
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