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華海藥業(600521.SH):纈沙坦原料藥恢復歐洲藥典適應性(CEP)證書
格隆匯 12-18 09:15

格隆匯12月18日丨華海藥業(600521.SH)公佈公司於2018年7月7日公告了《浙江華海藥業股份有限公司關於纈沙坦原料藥的未知雜質中發現極微量基因毒性雜質的公告》,公司暫停出口纈沙坦原料藥。隨後,EDQM(歐洲藥品質量管理局)暫停公司纈沙坦原料藥CEP(歐洲藥典適應性證書)證書。

公司按EDQM的要求對纈沙坦原料藥的工藝進行了改進並重新評估,建立了相應的控制措施並對CEP申報文件進行了修訂,之後公司向EDQM遞交了恢復纈沙坦原料藥CEP證書的申請文件。

2019年12月17日晚間公司查詢EDQM官方網站獲悉,公司的纈沙坦原料藥CEP證書於2019年12月16日批准恢復,證書編號為R1-CEP 2010-072-Rev01,纈沙坦原料藥將獲准恢復出口歐盟的資格。

目前公司尚未收到書面證書,具體將以公司收到EDQM更新後的紙質證書為準。

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