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仟源醫藥(300254.SZ):注射用阿洛西林鈉抽檢批次不合格不會對公司經營產生重大不利影響
格隆匯 09-15 16:25

格隆匯 9 月 15日丨仟源醫藥(300254.SZ)公佈,近日,有媒體以《山西仟源醫藥藥品又現質量缺陷,上半年虧損7500餘萬元》、《1批次注射用阿洛西林鈉不合格、17億市值的仟源醫藥上國藥局黑名單》等文章,報道了公司1批次注射用阿洛西林鈉被福建省食品藥品質量檢驗院檢驗不合格。

2020年9月9日,國家藥監局發佈《關於20批次藥品不符合規定的通告》(2020年第57號),公告了山西仟源醫藥集團股份有限公司(以下簡稱“公司”)生產的1批次注射用阿洛西林鈉不符合規定,不符合規定項目為溶液的澄清度。經查,公司在2020年國家藥品抽檢中被抽取的2.0g注射用阿洛西林鈉(20190601批),經福建省食品藥品質量檢驗院檢驗為不合格(檢驗報告編號:2020C0375),不合格項為溶液的澄清度。

公司獲得檢驗報告後,立即啟動了召回程序,暫停了該產品生產,並主動收集不良反應報告;截止目前,公司未收到任何關於該產品的不良反應報告的反饋。公司2019年度注射用阿洛西林鈉銷售收入117.37萬元,佔營業收入比例為0.10%;2020年除福建省食品藥品質量檢驗院購買140支用於抽檢外,公司未對外銷售注射用阿洛西林鈉。截止目前,公司已出售的產品在患者使用過程中未發生不良事件,未收到任何不良反應的反饋。

本次公司阿洛西林鈉抽檢批次不合格事項,可能導致公司被藥品監督管理部門處罰,但是,不屬於嚴重損害投資者合法權益或者社會公共利益的重大違法行為,不會對公司生產經營產生重大不利影響。

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