湖南华纳大药厂股份有限公司 自愿披露关于子公司通过巴西国家卫生监督局GMP认证的公告

Core Viewpoint - Hunan Warner Pharmaceutical Co., Ltd.'s subsidiary has successfully obtained GMP certification from Brazil's National Health Surveillance Agency (ANVISA) for the active pharmaceutical ingredient fosfomycin trometamol, enabling market entry into Brazil and enhancing international competitiveness [1][2]. Group 1: Certification Details - The GMP certification was issued for Hunan Warner Pharmaceutical Chiral Drugs Co., Ltd. for the production of fosfomycin trometamol [1]. - The certification number is 1435341/23-6, and it is valid until January 19, 2028 [1]. - The production facility is located at 139 Tongguan Avenue, Tongguan Circular Economy Industrial Base, Wangcheng District, Changsha, Hunan Province [1]. Group 2: Product Information - Fosfomycin trometamol is used as an active ingredient in formulations for treating acute uncomplicated urinary tract infections caused by sensitive strains of Escherichia coli, Enterococcus faecalis, Klebsiella pneumoniae, Citrobacter species, Enterobacter species, and Proteus mirabilis [1]. Group 3: Market Impact - The successful GMP certification lays a solid foundation for expanding into the Brazilian market and other international markets, thereby enhancing the company's international competitiveness [2].

湖南华纳大药厂股份有限公司 自愿披露关于子公司通过巴西国家卫生监督局GMP认证的公告 - Reportify