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九洲藥業(603456.SH):子公司通過美國FDA現場檢查
格隆匯 08-12 15:37

格隆匯8月12日丨九洲藥業(603456.SH)公佈,公司子公司瑞博(蘇州)製藥有限公司(以下簡稱“瑞博蘇州”)於2025年5月19日至2025年5月22日期間接受了美國食品藥品監督管理局(以下簡稱“FDA”)的cGMP(現行藥品生產質量管理規範)現場檢查,檢查範圍涵蓋質量體系、物料、生產、包裝與標籤、設備設施、實驗室控制六大系統。近日,瑞博蘇州收到美國FDA簽發的現場檢查報吿(EIR,Establishment Inspection Report),該報吿表明瑞博蘇州已通過本次cGMP現場檢查。

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