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 ...
Active Ingredient: Any component of a drug product intended to furnish ... Bulk
Drug Substance: According to 21CFR207.3(a)(4) means any substance that is ...
This means starting with the active pharmaceutical ingredient (API) in its purest ...
Using bulk ingredients in a compounded medication is the surest, safest way of ...
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 ...
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 ...
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 made
in ... Therefore though the goal may be different, the means turn out to be the
Definition: API. a.k.a. bulk drug substance [21 CFR 207.3]. ▫ "any substance that
is represented for use in a drug and that, when used in the manufacturing,.
[21 CFR 207.3(a)(4)] a.k.a. bulk drug substance. "any substance ... Definition:
Prescription (Rx) drugs .... A valid NDC number means the drug is approved: (T)