On August 12, Jiuzhou Pharmaceutical(603456) announced that its subsidiary, Ruibo (Suzhou) Pharmaceutical Co., Ltd., successfully passed a cGMP on-site inspection by the U.S. Food and Drug Administration (FDA) from May 19 to May 22, 2025, with a NAI (No Action Indicated) result. The inspection covered six major systems: quality systems, materials, production, packaging and labeling, equipment and facilities, and laboratory controls. The inspection involved the production of active pharmaceutical ingredients (APIs) Entresto, Kisqali, and Pyrenamine 07.

This FDA on-site inspection demonstrates that Ribo Suzhou complies with US FDA requirements for its pharmaceutical cGMP quality management system and production environment and facilities. This provides assurance for the company's continued international expansion and has a positive impact on its expansion into regulated markets globally. Furthermore, the company has established a hierarchical cGMP quality management system for R&D, production, quality control, and project management that meets leading global industry standards, which is expected to enhance the company's overall competitiveness and future development.

By mid-2025, Jiuzhou Pharmaceutical achieved revenue of 2.871 billion yuan and net profit attributable to shareholders of the parent company of 526 million yuan.

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