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]

Group 1 - The company successfully passed the FDA cGMP inspection at its Badu factory from March 17 to March 21, 2025, indicating compliance with quality management systems and production environment standards required by the FDA [1][4] - The inspection covered six major systems: quality system, materials, production, packaging and labeling, facilities, and laboratory controls [1] - The FDA issued an Establishment Inspection Report (EIR) confirming that the company met the necessary requirements, which supports the company's efforts to expand into international markets [1] Group 2 - The inspection results were classified as NAI (No Action Indicated), which is a favorable outcome for the company [4] - The products involved in the inspection include active pharmaceutical ingredients such as Ipratropium, Abiraterone Acetate, and Pregabalin [4] - The successful inspection is expected to have a positive impact on the company's ability to enter and grow in global regulated markets [1]