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Nanjing Chiatai Tianqing Roxadustat Generic Drug Applied for Production Yi/PharmaSources
May 29, 2023
In May 2023, the CDE announced the acceptance of eight generic drug marketing applications for Roxadustat from: Nanjing Chiatai Tianqing, Wanbangde Pharmaceutical, Shanxiang Pharmaceutical, Chengdu Brilliant.
Updates on the Bioequivalence Studies for Drugs Submitted to Under an ANDA Lin Zhang
April 08, 2022
From time to time, the Food and Drug Administration (FDA) offers a lot of updates to its materials and practices, and any person involved with the industry needs to stay alert for new releases, educational events, and training.
New Breakthrough in Epilepsy Drug: First Generic Drug of Eslicarbazepine Will Be Approved Soon PharmaSources/Yi
October 27, 2021
A few days ago, the marketing application (the relevant acceptance No. is CYHS2100147) of type 3 generic drugs "Eslicarbazepine Acetate" submitted by Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd....
Advancing Generic Drug Development to Approval Lin Zhang
October 22, 2021
The FDA continuously works to change and improve their work, including the work done with generic drugs. Last month, September 21-22, 2021, the Food and Drug Administration (FDA) hosted a workshop...
What’s New on FDA Generic Drugs Forum 2021? LIN ZHANG
May 08, 2021
Once a year, the Generic Drugs Forum was held on April 28 - 29, 2021 by the FDA Office of Generic Drugs (OGD).
Pharmaceutical News of August | PharmaSources.com: Approval PharmaSources/Caicai
September 23, 2020
Information on two proposed breakthrough therapies was publicized on the CDE website, separately YY-20394 tablets (linperlisib) of YL-Pharma and plinabulin concentrated solution for injection of BeyondSpring.
Pharmaceutical News of the Week (July. 13th-July. 17th) | PharmaSources.com - Updates on Approvals PharmaSources/Caicai
July 22, 2020
With the third week of July coming to a close, let’s review the hot events of the pharmaceutical industry this week. The news involved 5 sections: approval, R&D, policies, transactions, and miscellany that happened during July 13-17, including 30 pieces.
FDA Approves First Generic of Symbicort to Treat Asthma and COPD FDA
March 17, 2022
Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions...
FY 2021 GDUFA Science and Research Report FDA
March 09, 2022
The FY 2021 GDUFA Science and Research report provides detailed results for 13 areas of focus, each including a summary of research activities, research highlights, comprehensive lists of new, ongoing, and completed grants and contracts...
FDA issues series of guidances under Drug Competition Action Plan FDA
January 28, 2022
This week, FDA published a series of guidances focused on generic drug application submissions, labeling, and review. These guidances are part of our continued efforts to bring greater efficiency and transparency to the generic drug review process...

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