Aurisco Pharmaceutical reported that its cGMP manufacturing plant in Yangzhou, China has successfully passed U.S. FDA inspection. The FDA inspection confirmed the site is compliant with the principles and guidelines of good manufacturing practices (GMP) and no Form 483 observations or warning letters were issued.

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”.