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Active ingredient

en.wikipedia.org/wiki/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 ...

articles.economictimes.indiatimes.com/2002-12-30/news/27336226_1_bulk-drug-formulations-drug-manufacturers

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 [Food and Drugs] Law & Legal Definition

definitions.uslegal.com/b/bulk-drug-substance-food-and-drugs/

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 ...

Definition of a Drug

www.columbia.edu/cu/biology/courses/w4200/L1subsetfinal(2).ppt

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

Definitions - Pharmexcil

pharmexcil.org/uploadfile/ufiles/1535226443_definitions.pdf

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 ...

www.federalregister.gov/articles/2013/12/04/2013-28979/list-of-bulk-drug-substances-that-may-be-used-in-pharmacy-compounding-bulk-drug-substances-that-may

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 ...

207.3 - U.S. Food and Drug Administration

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=207.3

(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 ...

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

www.mymedsmatter.com/what-are-bulk-ingredients-and-why-are-they-necessary-compounding

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 ...

Compounding Definitions - American Veterinary Medical Association

www.avma.org/KB/Resources/Reference/Pages/Compounding-definitions.aspx

An active ingredient in unfinished form intended for manufacture into finished dosage form drug products. "Bulk" does not mean "quantity." Rather it means " raw" ...

Bulk Drug Substances - US Government Publishing Office

www.gpo.gov/fdsys/pkg/FR-2013-12-04/pdf/2013-28978.pdf

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 ...

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Bulk Drug | Define Bulk Drug at Dictionary.com
dictionary.reference.com/browse/Bulk Drug
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U.S. FDA Drug Definitions - Registrar Corp

www.registrarcorp.com

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, ...

What is meaning of bulk drugs - Answers.com

www.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 ...

Active Pharmaceutical Ingredients (APIs) in Medications - Pharmacy

pharmacy.about.com

Also known as bulk pharmaceuticals, active pharmaceutical ingredients, ... half of all APIs used around the world, meaning U.S. Food and Drug Administration ...