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騰盛博藥(02137.HK)新冠注射液生產基本符合GMP要求
阿思達克 06-01 00:25
騰盛博藥-B(02137.HK)公布,旗下控股公司騰盛華創在北京市藥品監督管理局對其及受託生產方,無錫藥明及上海藥明,針對新冠中和抗體安巴韋單抗注射液和羅米司韋單抗注射液的原液和製劑生產車間開展生產質量管理規範「GMP」符合性檢查後,獲得檢查結論。 結論表明,兩款注射液的生產基本符合《藥品生產質量管理規範》及其附錄要求,公司需進一步做好風險控制、並在與委託生產方合作完成具體整改要求後,啟動商業化生產及銷售。GMP符合性檢查的完成是安巴韋單抗和羅米司韋單抗聯合療法開始商業銷售前的最後一項監管要求。
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