Zhejiang Medicine's subsidiary, Xinchang Pharmaceutical Factory, passed the on-site inspection by the U.S. FDA
Zhejiang Medicine's subsidiary, Xinchang Pharmaceutical Factory, underwent a CGMP on-site inspection by the U.S. FDA from March 4 to March 7, 2025, covering four major systems including the quality system for oral solid preparations and active pharmaceutical ingredients. Xinchang Pharmaceutical successfully passed the inspection, meeting the U.S. drug CGMP quality system requirements, and has received the FDA's on-site inspection report confirming the completion of the inspection
According to the Zhitong Finance APP, Zhejiang Medicine (600216.SH) announced that its subsidiary, Xinchang Pharmaceutical Factory (hereinafter referred to as "Xinchang Pharmaceutical"), underwent an on-site inspection by the U.S. Food and Drug Administration (hereinafter referred to as "FDA") for CGMP (Current Good Manufacturing Practice) from March 4 to March 7, 2025. The inspection covered four major systems: quality systems, materials, production, and laboratory controls for oral solid dosage forms and active pharmaceutical ingredients.
Recently, Xinchang Pharmaceutical received a notification letter from the FDA along with the on-site inspection report (EIR) issued for this inspection, indicating that Xinchang Pharmaceutical complies with the U.S. drug CGMP quality system requirements and successfully passed the routine supervision inspection by the FDA. According to regulation 21CFR20.64(d)(3), the FDA confirmed that this inspection has concluded
