Core Viewpoint - The company successfully passed the FDA cGMP inspection for heparin sodium raw materials, indicating compliance with FDA standards and enhancing its competitiveness in the international market [1] Group 1: FDA Inspection Results - The company underwent an FDA cGMP site inspection from December 8 to December 11, 2025 [1] - The inspection result was classified as NAI (No Action Indicated), meaning no further action is required [1] Group 2: Market Implications - The successful FDA inspection strengthens the company's quality system in line with FDA cGMP requirements [1] - This achievement provides a solid foundation for the company to expand its heparin sodium raw materials in the U.S. market [1] - The positive outcome is expected to have a beneficial impact on the company's global market expansion efforts [1]
东诚药业:肝素钠原料药通过美国FDA检查