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昂利康(002940.SZ):七氟烷原料藥獲得化學原料藥上市申請批准通知書
格隆匯 06-15 18:27

格隆匯6月15日丨昂利康(002940.SZ)公佈,近日,浙江昂利康製藥股份有限公司子公司福建海西聯合藥業有限公司(簡稱“海西藥業”)收到國家藥品監督管理局關於原料藥七氟烷的《化學原料藥上市申請批准通知書》(通知書編號:2023YS00345)。

七氟烷是一種吸入性麻醉藥,由日本丸石製藥公司研究開發,其下游製劑產品適用於成年人和兒童的全身麻醉的誘導和維持,住院患者和門診患者均適用。

海西藥業於2021年12月遞交了七氟烷原料藥的藥品註冊申請並獲得受理。七氟烷原料藥現已通過CDE技術審評以及國家藥品監督管理局批准,尚需取得福建省藥品監督管理局GMP符合性檢查結果為“符合要求”的公示後,方可在國內生產、銷售。

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