Huahai Pharmaceutical subsidiary passes FDA inspection with zero deficiencies

Zhejiang Huahai Pharmaceutical Co., Ltd. announced that its subsidiary, Zhejiang Huahai Jiancheng Pharmaceutical Co., Ltd., passed a pre-approval inspection by the United States Food and Drug Administration (FDA) from July 14 to July 18, 2025. The inspection covered the factory's overall quality management system and the active pharmaceutical ingredient (API) gabapentin.

The inspection, categorized as a pre-approval inspection, concluded with a "No Action Indicated" (NAI) finding, signifying zero deficiencies. This outcome confirms that Huahai Jiancheng’s production base complies with current Good Manufacturing Practices (CGMP) for pharmaceutical products in the United States.

The successful FDA inspection for Huahai Jiancheng's quality management system and production facilities for gabapentin is expected to strengthen Zhejiang Huahai Pharmaceutical's ability to expand into international markets and enhance its core competitiveness. Gabapentin, used for treating epilepsy and neuropathic pain, is a globally significant prescription drug.