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九洲药业(603456.SH):子公司通过美国FDA现场检查

Core Insights - Jiuzhou Pharmaceutical (603456.SH) announced that its subsidiary, Rebo (Suzhou) Pharmaceutical Co., Ltd., successfully passed the cGMP inspection conducted by the FDA from May 19 to May 22, 2025 [1] Group 1 - The FDA inspection covered six major systems: quality system, materials, production, packaging and labeling, equipment facilities, and laboratory controls [1] - Rebo Suzhou received the Establishment Inspection Report (EIR) from the FDA, confirming compliance with cGMP standards [1]