華潤雙鶴(600062.SH):氯化鉀注射液、濃氯化鈉注射液獲得藥品補充申請批准通知書
格隆匯12月15日丨華潤雙鶴(600062.SH)公佈,近日,公司全資子公司華潤雙鶴利民藥業(濟南)有限公司(“雙鶴利民”)收到了國家藥監局頒發的氯化鉀注射液、濃氯化鈉注射液《藥品補充申請批准通知書》(通知書編號分別為:2021B03804、2021B03805)。
氯化鉀注射液為電解質補充藥,用於治療和預防各種原因引起的低鉀血癥以及用於洋地黃中毒引起頻發性、多源性早搏或快速心律失常。
雙鶴利民自2019年啟動氯化鉀注射液的質量提升研究工作,參考國家藥監局發佈的《化學仿製藥參比製劑遴選與確定程序》,選擇法國及匈牙利上市的規格一致的氯化鉀注射液作為市售對照品,於2021年1月5日向國家藥監局提交藥品補充申請,於2021年1月8日獲得受理通知書,並於2021年10月22日獲得國家藥監局批准。
截至公吿日,雙鶴利民針對氯化鉀注射液質量提升累計研發投入人民幣311萬元(未經審計)。
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