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Active ingredient


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

Formulations and bulk drugs: get the basics right - timesofindia ...


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 ...

Bulk Drug Substance definitions - Defined Term


"Bulk drug substance" means any substance that is represented for use, and that, when used in the compounding, manufacturing, processing, or packaging of a ...

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 ...

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 ...

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  ...

Federal Register | List of Bulk Drug Substances That May Be Used ...


Dec 4, 2013 ... To identify candidates for this bulk drugs list, interested groups and ... Section 503A refers to the definition of “bulk drug substance” in FDA ...

Active Pharmaceutical Ingredients (APIs) in Medications - Money


Also known as bulk pharmaceuticals, active pharmaceutical ingredients, or APIs, ... for biotech drugs fall under different definitions and regulatory schemes.

Bulk Drug Substances - US Government Publishing Office


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 ...

Compounding Definitions - American Veterinary Medical Association


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

Bulk Drug | Define Bulk Drug at Dictionary.com
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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, ...

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 ...

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 ...