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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 ...

FDA Regulation Of The Drug Industry - Registrar Corp

www.registrarcorp.com/fda-guidance/fda-definitions/drugs.jsp

Active Ingredient: Any component of a drug product intended to furnish ... Bulk Drug Substance: According to 21CFR207.3(a)(4) means any substance that is ...

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 ...

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

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

This means starting with the active pharmaceutical ingredient (API) in its purest ... Using bulk ingredients in a compounded medication is the surest, safest way of ...

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 ...

National Pharmaceutical Pricing Authority : Drug Price Control 1995 ...

nppaindia.nic.in/drug_price95/txt1.html

"bulk drug" means any pharmaceutical, chemical, biological or plant product including ... "dealer" means a person on the business of purchase or sale of drugs, ...

API manufacturing | Pharma API Industry Guide

www.mdtvalliance.org/

Dr. Reddy's is another leading manufacturer with 60 APIs for drug use, ... APIs are commonly referred to as 'bulk pharmaceuticals' and are in fact usually made in ... Therefore though the goal may be different, the means turn out to be the same ...

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,.

Interim Policy on Compounding Using Bulk Drug Substances Under ...

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 ...

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Bulk Drugs | Define Bulk Drugs at Dictionary.com
dictionary.reference.com/browse/Bulk Drugs
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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 ...

The Hindu : From bulk drugs to formulations

www.thehindu.com

Jan 19, 2004 ... Post-reforms, of course, the industry has learned to diversify from bulk drugs and face growing competition. Dr. Reddy's, perhaps, was one of ...