An active ingredient (AI) is the ingredient in a pharmaceutical drug that is
biologically active. The similar terms active pharmaceutical ingredient (API) and
Dec 30, 2002 ... This means the drug manufacturers more or less have the liberty to "formulate"
the bulk drug using excipents of his choice depending on ...
"Bulk drug substance" means any substance that is represented for use, and that,
when used in the compounding, manufacturing, processing, or packaging of a ...
(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
Regulatory Defined, Major Regulatory Bodies Worldwide); Basics of Drug ....
Alternatively referred to as bulk concentrate, bulk intermediate, or simply bulk.
Administration by a generic drug manufacturer challenging a patent held by an
innovator ... Bulk drugs: The active chemical substances in powder form, the main
Dec 4, 2013 ... To identify candidates for this bulk drugs list, interested groups and ... Section
503A refers to the definition of “bulk drug substance” in FDA ...
Also known as bulk pharmaceuticals, active pharmaceutical ingredients, or APIs,
... for biotech drugs fall under different definitions and regulatory schemes.
Dec 4, 2013 ... to the definition of ''bulk drug substance'' in FDA regulations at 21. CFR 207.3(a)(
4): ''any substance that is represented for use in a drug and ...
Definitions of terms related to veterinary compounding, including bulk drug, FDA-
approved drug, and compounded drug.