Xin Lang Cai Jing·2025-09-15 11:33Core Viewpoint - 康龙化成's wholly-owned subsidiary, 康龙化成（绍兴）药业有限公司, successfully passed the cGMP pre-market inspection by the FDA, confirming compliance with U.S. drug quality standards [1] Group 1: FDA Inspection Details - The inspection took place from May 29 to June 4, 2025, covering various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control systems [1] - 康龙绍兴 has received the FDA's on-site inspection report, affirming that its production facilities meet U.S. cGMP quality standards [1] Group 2: Significance of the Approval - This marks the first time 康龙化成's Shaoxing API commercial production base has passed the FDA's pre-approval inspection [1] - This follows the successful FDA inspection of 康龙化成's Ningbo API production workshop in April 2025, indicating a positive trend for the company's API production facilities in China [1]