华海药业(600521.SH)子公司华海建诚通过美国FDA现场检查

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Jiancheng Pharmaceutical Co., Ltd., successfully passed the FDA's pre-approval inspection for its manufacturing facility, confirming compliance with CGMP standards for the production of Gabapentin [1] Group 1 - The FDA conducted a pre-approval inspection from July 14 to July 18, 2025, covering the overall quality management system and the active pharmaceutical ingredient Gabapentin [1] - The inspection results indicate that the production base of Huahai Jiancheng meets the requirements of current Good Manufacturing Practice (CGMP) for pharmaceuticals [1]