An active ingredient (AI) is the ingredient in a pharmaceutical drug that is
biologically active. The similar terms active pharmaceutical ingredient (API) and
Jul 28, 2016 ... Also known as bulk pharmaceuticals, active pharmaceutical ingredients, or APIs,
... Defined as briefly as possible, active pharmaceutical ingredients are the ...
Drawing distinctions between APIs and drugs makes it possible for ...
Administration by a generic drug manufacturer challenging a patent held by an
innovator ... Bulk drugs: The active chemical substances in powder form, the main
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 ...
(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
Jan 19, 2004 ... Post-reforms, of course, the industry has learned to diversify from bulk drugs and
face growing competition. Dr. Reddy's, perhaps, was one of ...
Regulatory Defined, Major Regulatory Bodies Worldwide); Basics of Drug ....
Alternatively referred to as bulk concentrate, bulk intermediate, or simply bulk.
"capital employed" means net fixed assets plus working capital of a manufacturer
in relation to manufacture of bulk drugs; • "ceiling price" means a price fixed by ...
Dr. Reddy's is another leading manufacturer with 60 APIs for drug use, ... APIs
are commonly referred to as 'bulk pharmaceuticals' and are in fact usually ... the
means turn out to be the same as fewer reactions mean less solvent to dispose of