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復星醫藥(02196.HK)子公司通過GMP符合性檢查
格隆匯 12-20 19:01

格隆匯12月20日丨復星醫藥(02196.HK)公吿,近日,公司控股子公司湖南洞庭藥業股份有限公司收到湖南省藥品監督管理局簽發的《藥品GMP符合性檢查結果》。檢查結論:經藥品GMP符合性檢查及綜合評定,二車間硬膠囊生產線基本符合《藥品生產質量管理規範(2010年修訂)》要求。

本次檢查所涉生產設施為新增膠囊劑生產線,集團(即公司及控股子公司/單位,下同)針對本次檢查累計投入約為人民幣234萬元。

本次通過GMP符合性檢查為該新增膠囊劑生產線首次通過GMP符合性檢查。該生產線所涉產品鹽酸文拉法辛緩釋膠囊在商業化生產前,尚需(其中主要包括)獲得藥品註冊批准。本次通過GMP符合性檢查不會對集團現階段業績產生重大影響。

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