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翰宇藥業(300199.SZ):縮宮素原料藥獲得歐盟CEP證書
格隆匯 11-19 19:43

格隆匯11月19日丨翰宇藥業(300199.SZ)公佈,近日,公司的縮宮素原料藥收到了歐洲藥品質量管理局(“EDQM”)簽發的CEP(歐洲藥典適用性認證)證書。

縮宮素是一種由9個氨基酸殘基構成的環狀九肽化合物,合成環狀九肽具有由垂體後葉產生的激素結構,可刺激接受性哺乳動物的子宮收縮和泌乳。製劑臨牀用於引產、催產、產後及流產後因宮縮無力或縮復不良而引起的子宮出血和了解胎盤儲備功能(催產素激惹試驗)。

次縮宮素(原料藥)獲得歐洲藥品質量管理局簽發的CEP證書,為公司的縮宮素(原料藥)進入歐盟市場開拓了准入通道,對公司原料藥海外市場帶來積極影響,有利於提升公司的國際品牌影響力,公司將積極推動該藥品的上市銷售

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