千紅製藥(002550.SZ)獲得依諾肝素鈉注射液補充申請批件
格隆匯11月26日丨千紅製藥(002550.SZ)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)頒發的依諾肝素鈉注射液“藥品補充申請批件”。
一、關於增加藥品規格的補充申請情況
1.藥品名稱:依諾肝素鈉注射液
2.劑型:注射劑
3.規格:0.2ml:2000AXaIU;0.6ml:6000AXaIU
4.批件號:2019B04242、2019B04243
5.審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准本品增加0.2ml:2000AXaIU規格、0.6ml:6000AXaIU規格,核發藥品批准文號。
二、 關於與原研藥品生物等效的補充申請情況
1.藥品名稱:依諾肝素鈉注射液
2.劑型:注射劑
3.批件號:2019B03799
4.審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,接受本品與依諾肝素鈉注射液原研進口產品(商品名:克賽)生物等效的結論。
2015年5月,公司依諾肝素鈉原料藥及注射液(0.4ml:4000AXaIU)獲得國家藥監局頒發的《藥品註冊批件》,詳見公司於2015年5月28日披露的《關於獲得依諾肝素鈉及其注射液藥品註冊批件的公告》(公告編號:2015-030),上市銷售後取得了廣泛的市場認可。
因長遠規劃及市場需求,公司增加了兩個規格的申請,並同時遞交了與原研藥品生物等效的補充申請。此次獲批,進一步豐富了依諾肝素製劑產品線,有助於提升該產品的市場競爭力,對公司經營業績將產生積極影響。
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