烟台东诚药业集团股份有限公司关于肝素钠原料药通过美国FDA检查的公告

Group 1 - The company, Yantai Dongcheng Pharmaceutical Group Co., Ltd., successfully passed the FDA inspection for heparin sodium raw materials, indicating compliance with FDA cGMP requirements [1][3] - The FDA inspection took place from December 8 to December 11, 2025, and the company received a No Action Indicated (NAI) result, meaning no further action is required [3] - This successful inspection enhances the company's ability to expand its heparin sodium raw materials in the U.S. market, improving its international market competitiveness and positively impacting global market expansion [1]