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仟源醫藥(300254.SZ):1批次注射用阿洛西林鈉不合規 收到《行政處罰決定書》
格隆匯 09-29 20:18

格隆匯9月29日丨仟源醫藥(300254.SZ)公佈,2020年9月9日,國家藥品監督管理局發佈《關於20批次藥品不符合規定的通告》,公告了公司生產的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。

近日公司收到了山西省藥監局下發的《行政處罰決定書》,公司生產不符合藥品標準的注射用阿洛西林鈉(批號20190601)行為違反了《中華人民共和國藥品管理法》第四十九條第一款“禁止生產、銷售劣藥”、第三款(六)項“有下列情形之一的藥品,按劣藥論處:(六)其他不符合藥品標準規定的”的規定,構成生產劣藥的違法行為。

依據《中華人民共和國藥品管理法》第七十四條的規定,建議給予公司以下行政處罰:(1)沒收違法所得5.84萬元;(2)處貨值金額二倍的罰款,罰款金額12.08萬元,罰沒款總計17.92萬元;(3)沒收注射用阿洛西林鈉(批號20190601)33盒(10支/盒)共330支。

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。

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