Recently, Jiangsu Haici Bio-Pharmaceutical Co., Ltd. ("Haici Bio"), a subsidiary of Yangtze River Pharmaceutical Group, achieved a major milestone by passing the on-site inspection of Japan's PMDA with zero defects. This is the first time the Group's API sector has undergone an on-site audit by a foreign official authority, indicating its quality management system and production standards meet international levels, laying a solid foundation for its global strategic layout. The PMDA certification also marks a key step for Haici Bio into the international market.
From July 8 to 11, 2025, two senior PMDA inspectors conducted a comprehensive and detailed on-site inspection of Haici Bio. They carried out a "microscope-like" review covering all staff, processes and systems, with strict scrutiny over document materials such as deviation management and change management, equipment operation and material management in production workshops, as well as instrument calibration and data records in testing centers. Every chromatogram and calibration record was required to be retrieved immediately.Faced with nearly stringent inquiries, the Haici team, relying on its sound documentation system and accurate on-site responses, ultimately won high praise from the inspectors with an impeccable "zero-defect" performance.
The certification holds multiple significances. On one hand, leveraging Tamoxifen Citrate, Yangtze River has forged its first cooperation with Japan's Sawai, successfully entering the supply chain of Japan's generic drug giant. On the other hand, the inspection offers valuable experience for Haici Bio to continuously optimize its quality management system. Haici Bio will take this certification as a new start, advance its international development strategy, and keep improving product quality and production management.
Yangtze River Pharmaceutical Group has always promoted high-quality development with a global perspective. Haici Bio's successful passing of the PMDA certification this time is not only an international recognition of the Group's quality management system, but also a significant manifestation of its internationalization process.In the future, the Group will continue to accelerate international innovative R&D, promote more high-standard APIs and preparations to enter the international market, continuously enhance international competitiveness, and steadily move towards the grand goal of "To Be a China-leading, World-class Pharmaceutical and Healthcare Group".
