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 the Compound component of a pharmaceutical drug product.

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

Examples of Drug Substance in a sentence

• For the avoidance of doubt, in no event shall Protalix be obligated to Manufacture or supply quantities of Drug Substance in excess of the Capacity Cap unless otherwise agreed by the parties.

• Within five (5) days following the Second Amendment Effective Date, Pfizer and Protalix shall each appoint a person (each a “Transition Manager” and together, the “Transition Team”) to facilitate a smooth transition of the Commercialization of the Drug Substance or Licensed Product from Protalix to Pfizer (or a Third Party designated by Pfizer) in Israel and from Pfizer to Protalix (or a Third Party designated by Protalix) in Brazil, and to implement the Transition Plan (as defined below).

• Following the release of the Drug Substance subject to the Purchase Order hereunder and the submission to Pfizer of the Manufacturing Certificate of Acceptance and the Certificate of Compliance (as defined in the Quality Agreement) relating to such released Drug Substance, each delivery of Drug Substance under a Purchase Order hereunder shall be accompanied by an invoice.

• The initial term for the supply of Drug Substance under this Section 5 shall be for ten (10) years after the Second Amendment Effective Date (the “Initial Supply Term”).

• Protalix shall not make any changes to its process, raw materials, supply sources, manufacturing locations or facilities (including Drug Substance storage facilities and equipment) used to make Drug Substance for Pfizer under this agreement, including any such changes that may require Pfizer to provide notification to Regulatory Authorities, except to the extent permitted under the Quality Agreement.

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 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 the active pharmaceutical ingredient.

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 collagenases derived from Clostridium histolyticum.

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