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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 definitions - Defined Term

definedterm.com/bulk_drug_substance

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

What is meaning of bulk drugs - Answers

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 ...

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 ...

207.3 - CFR - Code of Federal Regulations Title 21

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 ...

Import Specifics: Drugs - U.S. Food and Drug Administration

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,.

Active Pharmaceutical Ingredients (APIs) in Medications

www.thebalance.com/what-are-active-pharmaceutical-ingredients-or-apis-2663827

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

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 ...

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

www.federalregister.gov/articles/2014/07/02/2014-15367/bulk-drug-substances-that-may-be-used-to-compound-drug-products-in-accordance-with-section-503a-of

Jul 2, 2014 ... Bulk drug substances that were previously nominated will not be further ... Section 503A refers to the definition of “bulk drug substance” in FDA ...

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!
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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, ...

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 ...

Definitions - Pharmexcil

pharmexcil.org

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