九洲药业(603456.SH)子公司瑞博苏州通过美国FDA现场检查

Core Viewpoint - The company Jiuzhou Pharmaceutical (603456.SH) announced that its subsidiary, Rebo (Suzhou) Pharmaceutical Co., Ltd., successfully passed the cGMP inspection by the FDA, which enhances its capability to expand in international markets [1] Group 1: FDA Inspection Results - Rebo (Suzhou) underwent an FDA cGMP inspection from May 19 to May 22, 2025, covering six major systems: quality system, materials, production, packaging and labeling, facilities, and laboratory controls [1] - The establishment inspection report (EIR) received from the FDA confirms that Rebo (Suzhou) meets the cGMP quality management system and production environment standards required by the FDA [1] Group 2: Implications for Market Expansion - The successful FDA inspection provides a solid foundation for the company to continue expanding into international markets and positively impacts its ability to enter global regulated markets [1] - The company has established a tiered cGMP quality management system that aligns with global industry-leading standards in research and development, production, quality control, and project management, which will enhance its overall competitiveness and future development [1]