Baiotec (688177.SH): The formulation section of the Yonghe factory does not meet the EU GMP requirements. Currently, the overall impact on the company's operations is relatively small.

date
14/06/2026
The Wise Finance and Economics APP reported that Baio (688177.SH) announced that the company underwent an on-site inspection by the French National Agency for Drug and Health Product Safety (ANSM) for compliance with the European Union Good Manufacturing Practice (EU GMP) from February 4 to February 12, 2026. Recently, the European Medicines Agency (EMA) notified the results of the GMP inspection as follows: (1) the raw materials section meets EU GMP requirements and the GMP certificate has been updated; (2) the formulation section does not meet EU GMP requirements, with the main defects involving inadequate deviation management measures at the company's Yonghe factory.