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

• For Advanced level practitioners with Privileges, credentialing will include current Drug Enforcement Agency (DEA) certificate or Controlled Drug Substance number as appropriate.

• Novavax will provide to SIIPL [***] necessary to enable SIIPL to formulate the components of the Vaccine Components (i.e. the Drug Substance and the Adjuvant), [***], so as to enable SIIPL to formulate the Vaccine Components and Manufacture the Product.

• The Parties agree that Novavax and SIIPL shall enter into a manufacturing agreement on terms and conditions as may be mutually agreed, wherein SIIPL shall manufacture the Drug Substance and Product for Novavax (the “Manufacturing Agreement”).

• CLIENT shall provide XXXXXX a Material Safety Data Sheet for Bulk Drug Substance and for each Drug Product.

• Furthermore, the Parties agree that during the Pandemic Period, for all Product for which the Drug Substance component has been Manufactured at any other location besides at a facility owned or controlled by SIIPL or an Affiliate, shall only be made available for purchase by the global allocation body endorsed by CEPI, currently expected to be the “COVAX Facility” or such other purchasing authority that Novavax in good faith represents has been endorsed and approved by CEPI.

More Definitions of Drug Substance

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 bulk BIWI1 as defined in the License Agreement.

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 or any other product as defined in a Work Order that is produced by cell culture and purification process from a MCB or 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 bulk Client Product, which has not yet been packaged into its final dosage form.

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.