Bulk drug substance definition
Bulk drug substance means any substance that is represented for use, and that, when used in the
Bulk drug substance means any substance that is represented for use, and that, when used in the compounding, manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug; however, "bulk drug substance" shall not include intermediates that are used in the synthesis of such substances.
Bulk drug substance means a Drug Product Candidate in bulk crystal, powder or other form suitable for incorporation in a Drug Product.
More Definitions of Bulk drug substance
Bulk drug substance means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances;
Bulk drug substance means the Compounds in bulk form which, if appropriately formulated and finished, would be suitable for preclinical or clinical use or commercial use.
Bulk drug substance means a Compound in bulk crystal, powder, solution or other form suitable for incorporation in a Drug Product, which if required in order to stabilize the Compound shall be formulated with stabilizing excipients.
Bulk drug substance means an siRNA (including chemical modifications and covalent conjugates) or other active ingredient in bulk form manufactured for use as an active pharmaceutical ingredient in a Licensed Product.
Bulk drug substance means any substance that, when used in the preparation of a compounded drug preparation, processing, or packaging of a drug, is an active ingredient or a finished dosage form of the drug, but the term does not include any intermediate used in the synthesis of such substances.
Bulk drug substance means COMPOUND in bulk form which, if appropriately formulated and finished, would constitute PRODUCT, and which shall be supplied by TANABE pursuant to Section 7.1.
Bulk drug substance. BII shall supply to BMI [*] of Omega Interferon bulk substance. BMI agrees to use such bulk substance exclusively for [*] as described in Appendix E and a [*] as described in Appendix F. BMI acknowledges that this bulk drug substance has not been released for use in humans.”