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衞信康(603676.SH):子公司混合糖電解質注射液獲批
格隆匯 03-25 17:31

格隆匯3月25日丨衞信康(603676.SH)宣佈,近日,公司全資子公司白醫製藥收到國家藥品監督管理局核准簽發的混合糖電解質注射液(500ml)《藥品註冊證書》(證書編號:2021S00241)。藥品批准文號:國藥準字 H20213182;註冊分類:原化學藥品第6類。

2013年11月,白醫製藥向內蒙古自治區食品藥品監督管理局提交混合糖電解質注射液藥品註冊申請並獲受理。截至該公吿日,已投入研發費用人民幣266.58萬元。

混合糖電解質注射液主要成分為葡萄糖,果糖,木糖醇,氯化鈉,醋酸鈉,氯化鈣氯化鎂,磷酸氫二鉀三水合物,硫酸鋅,適用於不能口服給藥或口服給藥不能充分攝取時,補充和維持水分及電解質,並補給能量。原研產品為日本大冢製藥株式會社於1994年6月上市的トリフリード輸液(TRIFLUID®Injection)。

經檢索,截至該公吿披露日,該品種目前國內已經獲得批准的廠家有:江蘇正大豐海製藥有限公司,中國大冢製藥有限公司,麗珠集團利民製藥廠,華仁藥業股份有限公司等;國內其他申報廠家有:珠海經濟特區生物化學制藥廠、湖北一半天製藥有限公司。

根據米內網數據統計,2020年混合糖電解質注射液在我國城市、縣級、社區及鄉鎮三大終端公立醫療機構的銷售額約為6.6億元。

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