浙江华海药业股份有限公司关于子公司通过美国FDA现场检查的公告

Group 1 - The core point of the announcement is that Zhejiang Huahai Pharmaceutical Co., Ltd.'s subsidiary, Zhejiang Huahai Jiancheng Pharmaceutical Co., Ltd., successfully passed the FDA's pre-approval inspection, indicating compliance with the FDA's quality management system requirements [1][2] - The inspection took place from July 14 to July 18, 2025, covering the overall quality management system of the factory and the active pharmaceutical ingredient Gabapentin [1] - The inspection result was classified as NAI (No Action Indicated), which signifies zero defects in the inspection [1] Group 2 - The successful FDA inspection enhances the company's ability to expand in international markets and positively impacts its core competitiveness and sustainable development [2] - Gabapentin, primarily used for treating epilepsy and neuropathic pain, is one of the most prescribed drugs globally, indicating its significant role in the pharmaceutical market [1][2] - The company's Gabapentin active pharmaceutical ingredient is already registered in multiple countries, including Europe, the United States, and South Korea [1]