Aurisco Successfully Passed FDA Inspection
The US Food and Drug Administration’s (USFDA) cGMP inspection of Yangzhou, China’s API and FDF plant, was successfully completed, according to a release from Aurisco.
As initially anticipated, the inspection (7–11 August 2023) was conducted by Mrs. Michele Glendenning, FDA Consumer Safety Officer. The site was found to be in compliance with the GMP principles and regulations during the FDA inspection, and no Form 483 observations were made.
The inspector expressed her satisfaction with the workshops and labs she had visited during the closing meeting, complimenting Aurisco on its GMP system and documentation, inspection organization, and team members’ expertise.
Dr. Wang Guoping, General Manager of the Yangzhou site, said “This successful FDA inspection is very important for our customers, as it confirms the cGMP status of this site, where we offer CDMO services, manufacture generic APIs like Dydrogesterone, Brivaracetam, Bempedoic acid, Dolutegravir sodium, Rimegepant, Vibegron and will soon produce peptides such as Semaglutide. This site also manufactures Auxiton®, the first NMPA approved generic dydrogesterone tablets, with a Marketing Authorization for the Chinese Market”.
Dr. Li Jinliang, Board Director of Aurisco, said “We are pleased to have another successful FDA inspection. Quality is very important for us, and this inspection demonstrates the safety of our products and cGMP compliance of our quality system. This successful result is a team effort and I congratulate the entire team for being so committed.”
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