Shuode Pharmaceutical, a subsidiary of Yuandong Biotech (688513.SH), passed the US FDA on-site inspection

Zhitongcaijing · 09/24/2023 08:17

According to Zhitong Finance APP, Yuandong Biotechnology (688513.SH) announced that the company’s wholly-owned subsidiary Chengdu Shuode Pharmaceutical Co., Ltd. (referred to as “Shuode Pharmaceutical”) accepted an application form from April 10 to 18, 2023. The cGMP (Current Good Manufacturing Practice) on-site inspection by the U.S. Food and Drug Administration ("FDA") covers the pre-approval inspection of nalmefene hydrochloride injection and nicardipine hydrochloride injection. Recently, Shuode Pharmaceutical received an on-site inspection report (EIR) from the US FDA. The FDA confirmed that the inspection has ended and Shuode Pharmaceutical passed the on-site inspection.