精華製藥(002349.SZ)控股子公司被收回GMP證書
格隆匯12月1日丨精華製藥(002349.SZ)公佈,2019年11月30日,公司收到控股子公司保和堂(亳州)製藥有限公司(以下簡稱"亳州保和堂")報告,該企業收到安徽省藥品監督管理局收回其《藥品GMP證書》的通知。現將有關事項説明如下:
2019年11月19-21日,安徽省藥品監督管理局對亳州保和堂開展GMP有因(飛行)檢查,發現2條嚴重缺陷、1條主要缺陷、3條一般缺陷,經綜合判定該企業不符合《藥品生產質量管理規範》要求。依據《藥品生產質量管理規範認證管理辦法》第三十三條規定,決定收回該企業的《藥品GMP證書》。亳州保和堂藥品GMP證書認證範圍:中藥飲片(淨制、切制、蒸制、煮制、炒制、灸制、煅制、煨制、制炭、燀制、水飛),毒性飲片(淨制、切制、煮制、炒制、水飛)。
公司對該事項高度重視,要求亳州保和堂針對檢查中存在的問題,深刻反省造成管理缺陷的根源,立即制定整改方案,舉一反三進行徹底整改,並儘快將整改情況上報藥品監督管理部門。同時,公司將對亳州保和堂管理層人員和分工進行重新調整。
根據《藥品生產質量管理規範認證管理辦法》第三十四條規定:藥品監督管理部門收回《藥品GMP證書》時,應要求企業改正。公司完成改正後,應將改正情況向藥品監督管理部門報告,經藥品監督管理部門現場檢查,對符合藥品GMP要求的,發回原《藥品GMP證書》。亳州保和堂被收回《藥品GMP證書》,將造成該企業中藥飲片暫時性停產,2019年1-10月銷售中藥飲片3,656.07萬元,產生毛利203.00萬元,對公司年度業績影響很小,敬請投資者注意投資風險。
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