Huahai Pharmaceutical subsidiary passes US FDA inspection

Zhejiang Huahai Pharmaceutical Co., Ltd. announced that its subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., Ltd. (Huahai Technology), successfully passed an on-site inspection by the U.S. Food and Drug Administration (FDA). The inspection, which took place from August 18 to August 22, 2025, covered the factory's overall quality management system and oral solid dosage products.

The company received a report confirming that Huahai Technology's production base complies with U.S. drug CGMP (Current Good Manufacturing Practice) requirements. This successful inspection, concluded with a VAI (Voluntary Action Indicated) classification, signifies that the company's quality management system and production facilities meet FDA standards.

This achievement is expected to provide a solid guarantee for the company's continued expansion in international markets, positively impacting its core competitiveness and sustainable development. However, the company cautioned investors that future sales of pharmaceutical products are subject to market changes, highlighting the inherent uncertainty and encouraging prudent investment decisions.