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.
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.
Latest

