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金城醫藥(300233.SZ):金城泰爾磷酸奧司他韋原料藥和普羅雌烯原料藥生產線通過藥品GMP符合性檢查
格隆匯 06-21 20:56

格隆匯6月21日丨金城醫藥(300233.SZ)公佈,公司全資子公司北京金城泰爾製藥有限公司(簡稱“金城泰爾”)於近日收到北京市藥品監督管理局下發的《藥品GMP符合性檢查吿知書》,其申報的磷酸奧司他韋原料藥生產線、普羅雌烯原料藥生產線已通過《藥品生產質量管理規範》符合性檢查。

磷酸奧司他韋是其活性代謝產物(奧司他韋羧酸鹽)的前體藥物,奧司他韋羧酸鹽是選擇性的流感病毒神經氨酸酶抑制劑。目前國內磷酸奧司他韋的相關劑型為膠囊、顆粒劑和幹混懸劑,臨牀上主要適用於成人、1歲及1歲以上兒童的甲型和乙型流感治療,成人、13歲及13歲以上青少年的甲型和乙型流感的預防。目前,磷酸奧司他韋原料藥國內主要生產廠商有上海迪賽諾化學制藥有限公司、宜昌東陽光長江藥業股份有限公司等企業。

普羅雌烯是一種合成雌激素,局部用於治療外陰陰道萎縮症狀,並加速外陰陰道手術或創傷(例如產後)後的傷口癒合。國內普羅雌烯的相關劑型有軟膠囊、乳膏劑及陰道片。該產品在國外40多個國家已臨牀使用40餘年,在許多國家是治療陰道感染和萎縮性陰道炎的一線藥物。目前,普羅雌烯原料藥國內主要生產廠商有亞寶藥業集團股份有限公司、北京斯利安藥業有限公司等企業。

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