Bulk Drug | Define Bulk Drug at Dictionary.com
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An active ingredient (AI) is the ingredient in a pharmaceutical drug that is
biologically active. The similar terms active pharmaceutical ingredient (API) and
Bulk Drug Substance: According to 21CFR207.3(a)(4) means any substance that
is represented for use in a drug and that, when used in the manufacturing, ...
Administration by a generic drug manufacturer challenging a patent held by an
innovator ... Bulk drugs: The active chemical substances in powder form, the main
(4) 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
Bulk drugs save money. Buying 500 cephalexin can cost 5.00 where as 100 can
cost 4.88.Another very common use for this term is active pharmaceutical.
Bulk drug substances (i.e., active ingredients) used to compound must be: –
components of FDA-approved drugs;. – the subject of a USP or NF monograph;
Pursuant to 21 CFR 207.3 (4) [Title 21 Food and Drugs; Chapter I Food and Drug
Administration, Department of Health and Human Services; Subchapter C ...
Definitions of terms related to veterinary compounding, including bulk drug, FDA-
approved drug, and compounded drug.