Dr. Margaret A. Hamburg, the commissioner of the United States Food and Drug Administration, arrived in India this week to express her growing unease with the safety of Indian medicines because of “recent lapses in quality at a handful of pharmaceutical firms.” India's pharmaceutical industry supplies 40.
More tests of hospital medicines found dozens more that were substandard, including a crucial intravenous antibiotic used in sick infants.
NEW DELHI — India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines.
One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab.
No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won't permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms.
It is an FDA requirement that the active ingredient of a generic drug be absorbed into the body and metabolized in approximay the same amount over approximay the same period as the active ingredient of the innovator drug. Bioequivalence is demonstrated in two ways. Dissolution testing determines if the generic drug product dissolves in approximay the same amount of time as the innovator product. Blood-level testing is done by giving the generic drug product to humans and measuring how much of the drug enters the bloodstream, how fast it does so, and how long it takes to leave the body.
Two private-label drug brands, NorthStar Rx generic pharmaceuticals and Sunmark, are available in addition to our competitively priced brand name and generic drugs. Through our NorthStar Rx brand, we offer high-quality generic drugs, manufactured at FDA-approved facilities. Our broad portfolio of private-label generics.
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Two private-label drug brands, NorthStar Rx generic pharmaceuticals and Sunmark, are available in addition to our competitively priced brand name and generic drugs.
High-Quality Generic Pharmaceuticals from Northstar Rx LLC.
FDA Electronic Orange Book.
Food and Drug Administration's (FDA) official book of approved drugs, including patent dates. The U.S.
USP is the official public standards-setting authority for all prescription (brand and generic) and over-the-counter medicines, dietary supplements, and other products manufactured and sold in the United States.
Pharmacy Facts and Figures, Drug Topics Magazine.
The Generic Pharmaceutical Association (GPhA) represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. MedWatch.
Office of Generic Drugs.
Lists the top brand and generic medicines by retail sales and prescriptions dispensed in 2008.
The FDA's safety information and adverse event reporting program.
This is a great database resource to find available generics. FDA's searchable database of approved medicines.
Department of Health and Human Services (HHS). U.S.
Generic Pharmaceutical Association (GPhA).
U.S. Pharmacopeia (USP). The Department of Health and Human Services (HHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
NorthStar Rx LLC manufactures, markets and/or distributes more than 72 drugs in the U.S.
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provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Data sources include Micromedex (updated Dec 4th, 2017), Cerner Multum (updated Dec 5th, 2017), Wolters Kluwer (updated Dec 1st, 2017) and others. To view content sources and attributions, please refer to our editorial policy. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
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Medications listed here may also be marketed under different names in different countries. NorthStar Rx LLC manufactures, markets and/or distributes more than 72 drugs in the United States. Non-US country and region specific information is not available on this page.
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