Aurisco Successfully Passes FDA Inspection

Aurisco Pharmaceutical announced that its API and FDF facility in Yangzhou, China successfully passed a current Good Manufacturing Practice (cGMP) inspection conducted by the US Food and Drug Administration (USFDA). The inspection, carried out by FDA Consumer Safety Officer Michele Glendenning, was conducted as originally planned over 5 days (7-11 August 2023). The FDA inspection confirmed that the facility complies with Good Manufacturing Practices (GMP) principles and regulations, and no Form 483 observations were issued. [caption id="attachment_155895" align="aligncenter"] Front view of Yangzhou Aurisco Pharmaceutical Co. Ltd[/caption] During the closing meeting, the inspector stated that he was satisfied with the workshops and laboratories he observed and commended Aurisco for its GMP system and documentation, inspection organization, and the knowledge of team members. Dr. Wang Guoping, General Manager of the Yangzhou facility, stated: "This successful FDA inspection is very important for our customers as it validates the cGMP status of this facility, where we provide CDMO services, manufacture generic APIs such as Dydrogesterone, Brivaracetam, Bempedoic acid, Dolutegravir sodium, Rimegepant, Vibegron, and will soon produce peptides such as Semaglutide. This facility also manufactures Auxiton®, the first NMPA-approved generic dydrogesterone tablets with Marketing Authorization for the Chinese market." [caption id="attachment_155897" align="aligncenter"] View from the QC Laboratory of Yangzhou Aurisco Pharmaceutical Co. Ltd[/caption] Dr. Li Jinliang, Board Director of Aurisco, stated: "We are pleased to have passed another successful FDA inspection. Quality is very important to us, and this inspection demonstrates the safety of our products and the cGMP compliance of our quality system. This successful result is a team effort and I commend the entire team for their dedication." Source