Web Results

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 ...

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 ...

What is meaning of bulk drugs - Answers.com

www.answers.com/Q/What_is_meaning_of_bulk_drugs

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/od/Glossary/g/What-Are-Active-Pharmaceutical-Ingredients-Or-Apis.htm

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

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 ... 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 ...

Import Specifics: Drugs - FDA

www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm117998.pdf

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,.

Interim Policy on Compounding Using Bulk Drug Substances ... - FDA

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf

Oct 27, 2015 ... A. Compounding From Bulk Drug Substances Under Section 503A of the ... 2 Section 503A references the definition of bulk drug substances in ...

Interim Policy on Compounding Using Bulk Drug Substances ... - FDA

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf

A. Compounding From Bulk Drug Substances Under Section 503B . ... to a facility that meets the definition of an outsourcing facility under section 503B(d)(4).

Answer
Bulk Drug | Define Bulk Drug at Dictionary.com
dictionary.reference.com/browse/Bulk Drug
The world's most popular free online dictionary with definitions, spell check, word origins, example sentences, audio pronunciations, Word of the Day and more!
More Info

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, ...

Definition of a Drug

www.columbia.edu

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

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

definitions.uslegal.com

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 ...