Ge Long Hui A P P·2025-09-15 10:35Core Insights - 康龙化成's subsidiary 康龙化成（绍兴）药业有限公司 successfully passed the cGMP pre-approval inspection by the FDA, confirming compliance with U.S. drug quality standards [1][2] - This marks the first successful FDA pre-approval inspection for the company's raw material drug commercialization production base in Shaoxing, following the successful inspection of the Ningbo facility in April 2025 [2] - With all four of the company's raw material drug production bases in China, the UK, and the US now FDA-approved, 康龙化成 is positioned to provide commercialized innovative drug active pharmaceutical ingredients (APIs) for global markets [2] Summary by Sections FDA Inspection - 康龙绍兴 received an Establishment Inspection Report from the FDA, confirming that its production facility passed the quality inspection [2] - The inspection covered various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control systems [1] Market Position - The successful FDA inspection indicates that 康龙化成's quality systems are aligned with international standards, enabling the company to continuously supply commercialized innovative APIs to the U.S. and global markets [2] - The company now has the capability to offer commercialized production solutions for innovative drug APIs tailored to different markets [2]