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溢多利(300381.SZ):甲潑尼龍琥珀酸鈉原料藥通過CDE技術審評審批
格隆匯 05-28 17:03

格隆匯5月28日丨溢多利(300381.SZ)公佈,公司之全資子公司河南利華製藥有限公司(“利華製藥”)的甲潑尼龍琥珀酸鈉原料藥於近日通過國家藥品監督管理局藥品審評中心(CDE)技術審評。

甲潑尼龍琥珀酸鈉是一種糖皮質激素類藥物,具有抗炎、抗免疫、抗休克、抗過敏功效,用於類風濕性關節炎、過敏、腫瘤、器官移植、哮喘、內分泌失調及血液等疾病的治療。

目前,國內進行原料藥甲潑尼龍琥珀酸鈉登記的公司僅有利華製藥和西班牙水晶醫藥公司(該產品來源:進口),其中利華製藥為國內甲潑尼龍琥珀酸鈉原料藥首家通過審評審批的廠家。

利華製藥甲潑尼龍琥珀酸鈉原料藥通過CDE技術審評,表明該原料藥符合國家相關藥品審評技術標準,已批准在國內上市制劑中使用,有利於公司加快原料藥產業佈局,完善原料藥產品結構,提升公司市場競爭力。

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