九洲药业: 浙江九洲药业股份有限公司关于子公司通过美国FDA现场检查的公告

Group 1 - The company, Zhejiang Jiuzhou Pharmaceutical Co., Ltd., announced that its subsidiary, Rebo (Suzhou) Pharmaceutical Co., Ltd., successfully passed the FDA's cGMP inspection conducted from May 19 to May 22, 2025 [1] - The inspection covered six major systems: quality system, materials, production, packaging and labeling, equipment facilities, and laboratory controls [1] - The inspection result was classified as NAI (No Action Indicated), indicating compliance with FDA standards [1] Group 2 - The successful FDA inspection provides a solid foundation for the company to expand its international market presence and positively impacts its ability to enter global regulated markets [1] - The company has established a tiered cGMP quality management system that meets global industry-leading standards, which enhances its overall competitiveness and future development [1]