Ge Long Hui·2025-09-16 03:12Core Viewpoint - 康龙化成's subsidiary successfully passed the FDA's cGMP pre-approval inspection, marking a significant milestone in its ability to produce commercialized innovative drug APIs for the US and global markets [1] Group 1: FDA Inspection and Approval - 康龙化成 (300759.SZ) announced that its wholly-owned subsidiary, 康龙化成（绍兴）药业有限公司, underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025 [1] - The inspection covered multiple GMP systems, and the facility successfully passed the FDA's on-site quality check, confirming compliance with US drug cGMP quality standards [1] - This marks the first time the Shaoxing API commercial production base has passed the FDA's new drug pre-approval inspection, following the successful inspection of the Ningbo API production facility [1] Group 2: Global Market Readiness - The successful inspection indicates that 康龙化成's quality system is aligned with international standards, enabling the company to continuously supply commercialized innovative drug APIs to the US and global markets [1] - Currently, 康龙化成 has four commercialized API production bases located in China, the UK, and the US, all of which have passed FDA inspections [1]