爾康製藥(300267.SZ):“磷酸氯喹”原料藥通過藥品GMP現場檢查
格隆匯2月28日丨爾康製藥(300267.SZ)公佈,2020年2月27日,公司全資子公司湖南湘易康製藥有限公司(“湘易康”)收到湖南省藥品監督管理局下發的《關於藥品GMP檢查結果的通知》,湘易康新增“磷酸氯喹”原料藥的生產資質。
湖南省藥品監督管理局於2020年2月25日至2月26日對湘易康的原料藥(APIⅢ生產車間:磷酸氯喹)按照《藥品生產質量管理規範》及其相關附錄進行現場檢查,經綜合評估,湘易康的原料藥(磷酸氯喹)APIⅢ生產車間符合《藥品生產質量管理規範》要求。
在此次GMP現場檢查前,湘易康“磷酸氯喹”原料藥已通過國家藥品監督管理局藥品審評中心(CDE)審批,與製劑共同審評審批結果為“A”,即“已批准在上市制劑使用”。
磷酸氯喹用於治療對氯喹敏感的惡性瘧、間日瘧等瘧疾,也可用於腸外阿米巴病的治療,還具有抗風濕等作用。2020年2月19日,國家衞生健康委員會印發新型冠狀病毒肺炎診療方案(試行第六版),磷酸氯喹作為抗病毒治療的試用藥物已被納入該版診療方案。
根據《中華人民共和國藥品管理法》及國家藥品註冊管理辦法的有關規定,湘易康具備了生產“磷酸氯喹”原料藥的資質。
此次通過原料藥GMP檢查,説明湘易康的“磷酸氯喹”原料藥符合國家GMP標準要求,有利於提升原料藥生產能力,豐富公司原料藥品種。公司將根據市場需求情況進行生產和銷售,並持續保持良好的生產管理和質量保證體系,積極履行社會責任。
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