Bulk Drug | Define Bulk Drug at Dictionary.com
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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 ...
Definitions - In this Order, unless the context otherwise requires: a. "bulk drug"
means any pharmaceutical, chemical, biological or plant product including its
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 ...
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.
Dec 4, 2013 ... Section 503A refers to the definition of “bulk drug substance” in FDA regulations
at 21 CFR 207.3(a)(4): “any substance that is represented for ...
The term "new drug" means …any drug the composition of which is such that ...
Alternatively referred to as bulk concentrate, bulk intermediate, or simply bulk.
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,.
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 ...