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 any substance that is represented for use in a drug and that, when used in the man- ufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermedi- ates used in the synthesis of such sub- stances.
Examples of Bulk drug substance in a sentence
Bulk drug substance is a white to pink crystalline powder.(b) (4)Deferiprone is highly soluble in water at pH 1-7.5 and has high permeability, thus is a BCS class 1 drug.
In such environments, employees need to be grated opportunities to meet together to share tacit knowledge that cannot be accommodated by archiven- based knowledge management platforms.
More Definitions of Bulk drug substance
Bulk drug substance means a Drug Product Candidate in bulk crystal, powder or other form suitable for incorporation in a Drug Product.
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 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 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 the Compound in bulk form, which if appropriately formulated and finished, would constitute the 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.