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Active ingredient - Wikipedia


An active ingredient (AI) is the ingredient in a pharmaceutical drug that is biologically active. The similar terms active pharmaceutical ingredient (API) and bulk ...

U.S. FDA Drug Definitions - Registrar Corp


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, ...

207.3 - CFR - Code of Federal Regulations Title 21


(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 drug ...

Definitions - Pharmexcil


Administration by a generic drug manufacturer challenging a patent held by an innovator ... Bulk drugs: The active chemical substances in powder form, the main  ...

What are Bulk Ingredients and Why are they Necessary for ...


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 ...

Active Pharmaceutical Ingredients (APIs) in Medications - The Balance


Jul 28, 2016 ... Also known as bulk pharmaceuticals, active pharmaceutical ... created for biotech drugs fall under different definitions and regulatory schemes.

Compounding Definitions - American Veterinary Medical Association


Definitions of terms related to veterinary compounding, including bulk drug, FDA- approved drug, and compounded drug.

Definition of a Drug


Regulatory Defined, Major Regulatory Bodies Worldwide); Basics of Drug .... Alternatively referred to as bulk concentrate, bulk intermediate, or simply bulk. Drug ...

Drug Substance | definition of Drug Substance by Medical dictionary

medical-dictionary.thefreedictionary.com/Drug Substance

Looking for online definition of Drug Substance in the Medical Dictionary? ... of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product.

Federal Register :: Bulk Drug Substances That May Be Used To ...


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) ...

Bulk Drug | Define Bulk Drug at Dictionary.com
dictionary.reference.com/browse/Bulk Drug
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What is meaning of bulk drugs - Answers.com


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 ...

Bulk Drug Substance [Food and Drugs] Law & Legal Definition


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 ...