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Generic = Branded Drug, What are the Facts? Krebs Qin
July 03, 2024
It is no secret that the U.S. military does not trust the quality of generic drugs, and their disagreements and disagreements with the FDA over the quality control of generic drugs have long been made public.
From CDMO Pharmaceutical Crisaborole First Generic Drug, Look at the Domestic PDE-4 Inhibitor R&D Development Layout Xiaobin
May 06, 2024
The NMPA official website showed that Zhejiang CDMO Pharmaceutical had submitted an application for the marketing application of crisaborole ointment as a generic drug and it was accepted by the Center for Drug Evaluation.
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.
First Generic Drugs Approved in China in 2022 Zhulikou/PharmaSources
February 15, 2023
List of the First Generic Drugs Approved in China in 2022
Boost for Dry Eye Disease Treatment As FDA Approves Generic Drug SHEM OIRERE
February 28, 2022
The Federal Drugs Agency (FDA) has approved the Abbreviated New Drug Application for the making of Cyclo-sporine Ophthalmic Emulsion 0.05%, the first generic version of AbbVie Inc's Re-stasis. (1)
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...
New Development of FDA Regulations on Complex Generic Drugs PharmaSources/Zhulikou431
June 03, 2021
Since the promulgation of the Hatch-Waxman Act in 1984, in order to promote drug competition and improve public drug availability, FDA has formulated a number of policies aimed at accelerating the marketing of generic drugs.
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).
Breaking News! Chia Tai Tianqing to Receive Approval for another Generic in China PharmaSources/Caicai
March 26, 2021
The marketing application (acceptance No.: CYHS1900381) of Chia Tai Tianqing’s Class 4 generic drug has recently changed to the “Under approval” status, and the drug is expected to be approved for marketing this month ...