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.
Drug Substance means an active ingredient as defined under § 210.3(b)(7) of this chapter.
Drug Substance means the Compound component of a pharmaceutical drug product.

Examples of Drug Substance in a sentence

  • SLS or its Authorized Manufacturer shall ship Drug Substance with [***].

  • The provisions set forth on Schedule 2.10 (Inventory of Drug Substance; Drug Substance Safety Stock) attached hereto shall apply to this Supply Agreement.

  • For the sake of clarity all Intellectual Property Rights in relation to the Adjuvant, Drug Substance and the Drug Product, shall be the exclusive proprietary concern of Novavax.

  • For the avoidance of doubt, the DS Supply Price only applies to Drug Substance delivered to Novavax or its designee in accordance with Section 2.4 of this Supply Agreement pursuant to Purchase Orders placed by Novavax, and does not apply with respect to (and Novavax shall not pay for any cost of Manufacturing) any Drug Substance that is utilized in the Manufacture of Drug Product by or on behalf of SLS under this Supply Agreement.


More Definitions of Drug Substance

Drug Substance means bulk BIWI1 as defined in the License Agreement.
Drug Substance means bulk Client Product, which has not yet been packaged into its final dosage form.
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.
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 the cell culture and purification process from the Working Cell Bank “WCB”.
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 recombinant human IgG1 monoclonal antibody targeting FGF23 identified as KRN23 with the amino acid sequence set forth on Schedule 1.1.15. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.