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 the Compound component of a pharmaceutical drug product.

Drug Substance means an active ingredient as defined under § 210.3(b)(7) of this chapter.

Examples of Drug Substance in a sentence

• II.2 Drug Substance The active substance is bortezomib, an established active substance not described in the European Pharmacopoeia (Ph.Eur.) or British Pharmacopoeia (BP).

• II.2 Drug Substance The active substance is sildenafil citrate, an established active substance described in the European Pharmacopoeia (Ph.Eur.).

• II.2 Drug Substance The active substance is voriconazole, an established active substance described in the European Pharmacopoeia (Ph.Eur.).

• PPD shall transfer to TSD ownership of all Drug Substance, CTM and Finished Product of SYR110322 and SYR110619 and any other Material in its possession as of the Effective Date of this Agreement, the amounts of which are listed on Schedule 3.3.

• II.2 Drug Substance The active substance is lenalidomide, an established active substance that is not described in the European Pharmacopoeia (Ph.Eur.).

More Definitions of Drug Substance

Drug Substance means the active pharmaceutical ingredient.

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 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 that is produced by cell culture and purification process from the 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.