上海医药两款药品通过仿制药一致性评价
Bei Jing Shang Bao·2025-11-10 10:19

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for its generic drugs, injectable Cefuroxime Sodium and injectable Aztreonam, confirming their quality and efficacy consistency [1] Group 1: Company Developments - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyuan New Asia Pharmaceutical Co., Ltd., has been granted a Supplementary Drug Application Approval Notice [1] - The injectable Cefuroxime Sodium is indicated for treating infections caused by specific strains of microorganisms in respiratory, ENT, and urinary tract infections, first launched in 1978 in countries like the UK and Italy [1] - The injectable Aztreonam is used for treating urinary tract infections (both complex and uncomplicated) and lower respiratory tract infections caused by sensitive Gram-negative bacteria, first launched in Italy in 1984 [1]