千红制药(002550.SZ)获得依诺肝素钠注射液补充申请批件
格隆汇11月26日丨千红制药(002550.SZ)公布,近日,公司收到国家药品监督管理局(“国家药监局”)颁发的依诺肝素钠注射液“药品补充申请批件”。
一、关于增加药品规格的补充申请情况
1.药品名称:依诺肝素钠注射液
2.剂型:注射剂
3.规格:0.2ml:2000AXaIU;0.6ml:6000AXaIU
4.批件号:2019B04242、2019B04243
5.审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注册的有关要求,批准本品增加0.2ml:2000AXaIU规格、0.6ml:6000AXaIU规格,核发药品批准文号。
二、 关于与原研药品生物等效的补充申请情况
1.药品名称:依诺肝素钠注射液
2.剂型:注射剂
3.批件号:2019B03799
4.审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注册的有关要求,接受本品与依诺肝素钠注射液原研进口产品(商品名:克赛)生物等效的结论。
2015年5月,公司依诺肝素钠原料药及注射液(0.4ml:4000AXaIU)获得国家药监局颁发的《药品注册批件》,详见公司于2015年5月28日披露的《关于获得依诺肝素钠及其注射液药品注册批件的公告》(公告编号:2015-030),上市销售后取得了广泛的市场认可。
因长远规划及市场需求,公司增加了两个规格的申请,并同时递交了与原研药品生物等效的补充申请。此次获批,进一步丰富了依诺肝素制剂产品线,有助于提升该产品的市场竞争力,对公司经营业绩将产生积极影响。
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