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吉藥控股(300108.SZ):江蘇省藥監局決定暫停克勝藥業片劑生產
格隆匯 05-26 21:00

格隆匯5月26日丨吉藥控股(300108.SZ)公佈,江蘇省藥品監督管理局於近日對公司控股孫公司江蘇普華克勝藥業有限公司(“克勝藥業”)進行了飛行檢查,於2020年5月20日對克勝藥業出具了《江蘇省藥品監督管理局告誡信》(編號:藥生告誡202002),指出了克勝藥業在藥品生產質量管理方面存在的相關問題和缺陷。於2020年5月21日在其網站上發佈了《江蘇省藥品生產企業風險控制措施公告》(2020年第2號),因克勝藥業違反了藥品生產質量管理相關規定。根據《藥品管理法》第九十九條規定,決定暫停克勝藥業片劑生產。

公司知悉相關事件後,與現任負責人詳細核查此事,對該事項高度重視,及時召開相關管理層會議,並要求克勝藥業全面梳理檢查中存在的問題,深刻反省造成管理缺陷的根源,查找漏洞,並監督克勝藥業根據飛行檢查要求在設備、採購、生產管理等方面逐一落實整改措施,並對產品進行了安全風險評估。目前,克勝藥業正在進行整改工作,並立即制定整改方案,將盡快向江蘇省食品藥品監督管理局提交復產檢查申請,檢查合格後方可恢復生產。

公司於2018年12月26日完成長春普華製藥股份有限公司(“普華製藥”)的收購,作為普華製藥的控股子公司克勝藥業於2019年4月11日完成工商變更登記,2019年克勝藥業銷售收入為4324.15萬元,淨利潤為-267.85萬元,對公司年度業績影響較小,敬請投資者注意投資風險。

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