Drug Substance definition

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.

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Drug Substance means bulk Client Product, which has not yet been packaged into its final dosage form.

Drug Substance means the Compound component of a pharmaceutical drug product.

Examples of Drug Substance in a sentence

Customer shall pay for all of the Services and the Batches (including Pilot Drug Substance Batches, Pilot Drug Product Batches, all cGMP Drug Substance Batches and all cGMP Drug Product Batches).
If there is a discrepancy between Customer’s and ▇▇▇▇▇’s test results such that Lonza’s test results fall within the relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall appoint an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the cGMP Drug Substance Batch that allegedly fails to conform to Specifications.
Lonza shall manufacture, or procure the manufacture of, the Pilot Drug Substance Batch(es) and the Pilot Drug Product Batch(es) in accordance with the Project Plan, but shall have no obligation to meet Specifications or Specification (Drug Product) or comply with cGMP in relation to the Pilot Drug Substance Batch(es) or the Pilot Drug Product Batch(es) (and Lonza makes no warranty in this regard).
Customer shall notify Lonza in writing of any rejection of a cGMP Drug Substance Batch (which was required to meet the Specifications) based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected cGMP Drug Substance Batches shall be deemed accepted.
Unless Lonza and Customer agree otherwise, all Pilot Drug Substance Batches and Pilot Drug Product Batches shall be shipped to Customer.

More Definitions of Drug Substance

Drug Substance means bulk drug substance that is represented for use in a drug that, when used in the Manufacturing of a drug, becomes an active pharmaceutical ingredient.

Drug Substance means the chemical substance identified as faropenem daloxate as its generic name (code number: SUN A0026) and having the chemical structure: (5-Methyl-2-oxo-1, 3-dioxolen-4-yl) methyl (5R, 6S)-6-[(R)-1-hydroxyethyl]-2-[(R)-2-tetrahydro-furyl] penem-3-carboxylate.

Drug Substance or "DS" means the bulk purified recombinant protein DX-2930 that is produced by cell culture and purification process from the WCB.

Drug Substance means the active pharmaceutical ingredient.

Drug Substance means the collagenases derived from Clostridium histolyticum.

Drug Substance means bulk BIWI1 as defined in the License Agreement.

Drug Substance means the active pharmaceutical ingredient for the chemical compound coded by Takeda as TAK-385, the structure of which is set forth on Schedule 1.138 of the License Agreement, with the Specifications (as defined below), and is Manufactured pursuant to Section 7.1 hereof. For clarity, such pharmaceutical ingredient under the Takeda Clinical Manufacturing and Supply Agreement shall not be included herein.