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復星醫藥(02196.HK)控股子公司生產線通過美國FDA現場檢查
格隆匯 10-11 16:25

格隆匯10月11日丨復星醫藥(02196.HK)公告,該公司控股子公司重慶醫工院製藥有限責任公司於2019年7月15日至2019年7月19日,接受了美國食品藥品監督管理局cGMP(即現行藥品生產質量管理規範)現場檢查。

近日,醫工院製藥收到美國FDA關於其103車間、104車間已符合cGMP標準的函和現場檢查報告。本次通過現場檢查表明醫工院製藥的103車間、104車間符合美國FDAcGMP標準,蔗糖鐵原料藥、卡格列淨原料藥均可進行商業化生產。本次通過檢查不會對集團(即公司及控股子公司/單位)現階段業績產生重大影響。

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