聯環藥業(600513.SH):公司通過美國FDA現場檢查
格隆匯9月3日丨聯環藥業(600513.SH)公佈,公司於2024年7月15日至2024年07月19日期間接受了美國食品藥品監督管理局(簡稱“FDA”)的cGMP(現行藥品生產質量管理規範)現場檢查。近日,公司收到美國FDA簽發的現場檢查報吿(EIR,EstablishmentInspectionReport),該報吿表明公司生產場地已通過本次cGMP現場檢查。
本次通過美國FDA現場檢查,表明公司在藥品cGMP質量管理體系和生產環境設施等方面符合美國FDA要求,為公司持續拓展國際市場提供了堅實的保障,並對拓展全球規範市場帶來積極影響。同時公司完善、有效的原料藥生產體系和管理理念也有助於公司加快自身原料藥生產體系的建設和提升,對提升公司綜合競爭力及未來發展有着積極的推動作用。
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