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, ...
(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
Administration by a generic drug manufacturer challenging a patent held by an
innovator ... Bulk drugs: The active chemical substances in powder form, the main
Because of these issues, when a drug is customized, or compounded, to meet ...
This means starting with the active pharmaceutical ingredient (API) in its purest ...
Jul 28, 2016 ... Also known as bulk pharmaceuticals, active pharmaceutical ... created for biotech
drugs fall under different definitions and regulatory schemes.
Definitions of terms related to veterinary compounding, including bulk drug, FDA-
approved drug, and compounded drug.
Regulatory Defined, Major Regulatory Bodies Worldwide); Basics of Drug ....
Alternatively referred to as bulk concentrate, bulk intermediate, or simply bulk.
Looking for online definition of Drug Substance in the Medical Dictionary? ... of
Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product.
Jul 2, 2014 ... Section 503B refers to the definition of “bulk drug substance” in FDA regulations
at § 207.3(a)(4) (21 CFR 207.3(a)(4)). See section 503B(a)(2) ...