Xin Lang Cai Jing·2025-09-15 10:28Core Viewpoint - 康龙化成's subsidiary successfully passed the FDA's cGMP pre-approval inspection, confirming compliance with U.S. drug quality standards [1] Group 1: FDA Inspection Details - 康龙化成 (Shaoxing) Pharmaceutical Co., Ltd. underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025, covering quality systems, material management systems, and production management systems [1] - The inspection report from the FDA confirmed that the production facility met the necessary standards and received FDA certification [1] Group 2: Significance of the Approval - This marks the first time the Shaoxing API commercial production base has passed the FDA's new drug pre-approval inspection [1] - This follows the successful inspection of the Ningbo API production workshop in April 2025, indicating a positive trend for the company's API production facilities in China [1]