Hanyu Pharmaceutical (300199.SZ): Pingshan Branch passed the US FDA on-site inspection

Zhitong Finance App News, Hanyu Pharmaceutical (300199.SZ) issued an announcement. The company's Pingshan branch underwent routine supervision and inspection of the current Pharmaceutical Production Quality Management Specification (cGMP) of the US Food and Drug Administration (FDA) from June 18 to 26, 2026. Recently, the company received an on-site inspection report issued by the FDA. The inspection covered the cGMP compliance of liraglutide injections (18mg/3mL, cartridge filling line) produced by the company for the US market, as well as requirements related to the Drug Supply Chain Safety Act (DSCSA).

This inspection is the second time that Pingshan Branch has been inspected by the FDA and successfully passed since it first passed the FDA Pre-Approval Inspection (PAI) from July to August 2023. The Pingshan branch of the company's peptide formulation production base, the Wuhan subsidiary of the API production base, and the R&D laboratory at Longhua headquarters have all obtained FDA on-site inspection reports (EIR). Among them, the Longhua headquarters R&D laboratory and the Wuhan subsidiary of the API production base have all previously passed the inspection with NAI (zero defects). Obtaining this on-site inspection report will help accelerate the US approval process for the company's peptide drugs and lay a good foundation for the internationalization strategy.