昂利康(002940.SZ):異氟烷原料藥通過藥品GMP符合性檢查
格隆匯1月25日丨昂利康(002940.SZ)公佈,近日,公司通過福建省藥品監督管理局網站獲悉子公司福建海西聯合藥業有限公司(以下簡稱“海西藥業”)藥品GMP符合性檢查結果公吿。檢查範圍:原料藥(異氟烷,原料藥合成車間異氟烷生產線)。
異氟烷原料藥原研是美國百特國際有限公司,用於成人和兒科患者的院內手術及門診手術的全身麻醉的誘導和維持。截至目前,根據國家藥品監督管理局藥品審評中心(以下簡稱“CDE”)網站,異氟烷原料藥除海西藥業外,現有1家國內企業原料藥通過CDE審評。
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