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 company Zhejiang Huahai Pharmaceutical Co., Ltd. announced that its subsidiary, Zhejiang Huahai Jiancheng Pharmaceutical Co., Ltd., passed the FDA pre-approval inspection, confirming compliance with CGMP requirements [1][2] - The inspection took place from July 14 to July 18, 2025, covering the overall quality management system and the active pharmaceutical ingredient Gabapentin [1][2] - Gabapentin is a widely prescribed medication for epilepsy and neuropathic pain, indicating its significant role in the global pharmaceutical market [1][2] Group 2 - The successful FDA inspection enhances the company's core competitiveness and supports its ongoing international market expansion [2] - The company has registered its Gabapentin products in multiple countries, including Europe, the United States, and South Korea, ensuring a stable market presence [1][2]