Jiangxi Fushine Pharmaceutical (300497.SZ) passed the on-site inspection by the US FDA.

Jiangxi Fushine Pharmaceutical (300497.SZ) announced that the company underwent an on-site inspection by the U.S. Food and Drug Administration (FDA) for current Good Manufacturing Practice (cGMP) from August 11, 2025, to August 14, 2025. The inspection covered various GMP systems, including quality system, material management system, production management system, equipment and facility system, packaging and labeling system, and laboratory control system. The company recently received an Establishment Inspection Report (EIR) issued by the FDA, and the inspection was successfully passed as a result of a Voluntary Action Indicated (VAI). This is the company's third successful cGMP on-site inspection by the FDA, indicating that the company's quality system is in line with international standards and has the qualifications to continuously provide commercial intermediates and active pharmaceutical ingredients for the U.S. and global markets. This achievement demonstrates the company's strict adherence to high-end international quality standards and is a strong affirmation of the effective operation of the company's management system, injecting momentum to achieve development goals, expand international markets, enhance overall competitiveness, and drive future growth in a positive way.