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紅日藥業(300026.SZ)控股子公司依諾肝素鈉原料藥通過CDE技術審評審批
格隆匯 12-25 17:09

格隆匯12月25日丨紅日藥業(300026.SZ)發佈公告,公司控股子公司湖北億諾瑞生物製藥有限公司(以下簡稱“億諾瑞”)的依諾肝素鈉原料藥於近日通過國家食品藥品監督管理總局藥品審評中心技術審評。

根據披露,億諾瑞是一家專注於肝素及低分子肝素原料藥產品的研發、生產、銷售的生物製藥企業,主要產品有肝素鈉(粗品)、肝素鈉、肝素鈣、依諾肝素鈉、那屈肝素鈣、低分子量肝素鈣、達肝素鈉等。公司具備自豬小腸刮制至肝素原料藥生產的全產業鏈生產條件,目前通過了中國、美國、德國、俄羅斯和土耳其等國家藥監官方GMP認證。

依諾肝素鈉為億諾瑞主打產品之一,主要用於預防和治療深靜脈血栓或肺栓塞。公司於2014年7月30日首次提出註冊申請並獲得受理(受理號:CYHS1401082)。依諾肝素鈉原料藥現已通過了藥審中心的審評,在藥審中心原料藥、藥用輔料和藥包材備案平台已經標記為“A”,可以在國內市場上銷售。

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