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How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product FDA
January 07, 2022
CDER Researchers have been investigating how pharmacokinetic (PK) modeling can support a determination of bioequivalence (BE) for topical drug products.
Yichang Humanwell’s Class 3 Generic Drug Alfentanil Hydrochloride Approved for Marketing PharmaSources/Caicai
March 16, 2020
The drug becomes one of the first alfentanil drugs approved for marketing in China. Alfentanil Hydrochloride Injection is a potent analgesic used for anesthesia and applies to short surgical procedures.
Harvest in 2019 year-end with the Marketing of Multiple Generic Drugs PharmaSources/Caicai
January 07, 2020
The NMPA is also “sprinting” as the year is coming to an end.
Report links greater generic competition and lower generic drug prices europeanpharmaceuticalreview
December 17, 2019
A new report from the FDA has shown that greater competition among generic drug makers is associated with lower generic drug prices.
Multiple First Generics of the Hard-to-Imitate to be Marketed Soon PharmaSources/Caicai
July 02, 2019
In terms of generic drug, Sino Biopharmaceutical will have more than 20 generic drugs marketed in the next 2-3 years
FDA moving to 'risk-based' inspections even as valsartan scare adds new wrinkle to oversight fiercepharma
January 31, 2019
FDA inspections of generic drug plants are on the rise and should continue to increase through 2019, Commissioner Scott Gottlieb said this week in a series of tweets.
Western Medicine Preparation Exportation of Chinese Pharmaceutical Enterprises to the U.S.(2) Xiaoyaowan
September 20, 2018
It is observed that FDA has been encouraging generic drug application in recent years, and continued to speed up review of generic drug ANDAs, with most of the approved products being competitive products of existing similar generic drugs.
FDA approves first generic drug under new CGT designation pharmaceutical-technology
August 13, 2018
The US Food and Drug Administration (FDA) has granted its first competitive generic therapy (CGT) designation to Apotex’s potassium chloride oral solution for hypokalemia in patients on diuretics.
Nonprofit Manufacturer Could Keep Generic Drug Costs Down drugs
May 17, 2018
A nonprofit manufacturer could help keep generic drug prices down and maintain their supply, according to a perspective piece published in the May 17 issue of the New England Journal of Medicine.
Top 6 Generic Drug Companies to Work For biospace
January 25, 2018
At one time the generic drug market was fragmented, but over the last several years it has consolidated significantly.

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