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尖峯集團(600668.SH):子公司通過美國FDA現場檢查
格隆匯 12-19 16:25

格隆匯12月19日丨尖峯集團(600668.SH)公佈,全資子公司浙江尖峯藥業有限公司(簡稱“尖峯藥業”)金西生產基地年產20億片固體制劑項目於2023年7月17日至2023年7月21日接受了美國食品藥品監督管理局(簡稱“美國FDA”)的現場檢查,本次檢查是美國FDA對尖峯藥業受託生產的左乙拉西坦緩釋片增加尖峯藥業為新生產基地的批准前現場檢查(簡稱“PAI”)。近日,尖峯藥業收到了美國FDA簽發的現場檢查報吿(EIR,EstablishmentInspectionReport),表明美國FDA對尖峯藥業的PAI檢查已結束,尖峯藥業通過了現場檢查,有資格進行該產品的生產。

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