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普利製藥(300630.SZ):泊沙康唑注射液獲得國家藥品監督管理局(NMPA)上市許可
格隆匯 06-30 16:37

格隆匯6月30日丨普利製藥(300630.SZ)公吿,海南普利製藥股份有限公司(以下簡稱“普利製藥”或“公司”)於近日收到國家藥品監督管理局(以下簡稱“NMPA”)簽發的泊沙康唑注射液的藥品註冊批件。

泊沙康唑注射液是一種抗真菌類藥物。泊沙康唑由默沙東公司研發,於2005年10月25日首次獲得歐洲藥物管理局批准上市,後於2006年9月15日獲得美國食品藥品管理局(FDA)批准上市,商品名“Noxafil”,其中Noxafil靜脈注射劑於2014年3月13日獲得FDA批准。2021年1月30日,由MerckSharp&DohmeB.V.持有的泊沙康唑注射液在中國獲批,規格為16.7ml:0.3g。

我公司該品種完成技術開發後,於2022年7月向美國食品藥品監督管理局的遞交仿製藥註冊申請,於2022年10月向國家藥品監督管理局遞交仿製藥註冊申請。近日,公司收到了國家藥品監督管理局簽發的泊沙康唑注射液藥品註冊批件,標誌着普利製藥具備在中國上市銷售泊沙康唑注射液的資格,將對公司拓展國內市場帶來積極影響。

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