Aurisco announces Yangzhou, China manufacturing site's successful FDA inspection
16 August 2023 -

China-based Aurisco Pharmaceutical announced on Tuesday that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).

The inspection, carried out by the FDA Consumer Safety Officer, Michele Glendenning, lasted five days (7-11. August 2023) as initially planned. Aurisco says that FDA inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued. At the closing meeting the inspector informed that she was satisfied with the workshops and labs she had seen and complimented Aurisco on its GMP system and documents, inspection organisation and the knowledge of its team members.

Dr Wang Guoping, Yangzhou site general manager, 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(R), the first NMPA approved generic dydrogesterone tablets, with a Marketing Authorisation for the Chinese Market."