普洛藥業(000739.SZ):控股子公司出口製劑車間通過WHO審計
格隆匯 8 月 16日丨普洛藥業(000739.SZ)公佈,公司控股子公司浙江普洛康裕製藥有限公司(“康裕製藥”)於近日收到世界衞生組織(“WHO”)簽發的關於公司出口製劑車間通過GMP審計的通知。
康裕製藥於2019年1月向WHO遞交了左氧氟沙星片(規格:250mg,500mg)的PQ申請,由此產生WHO對相關製劑產品生產線(同稱為“出口製劑車間”)的GMP審計。目前左氧氟沙星片項目正處於發補階段,公司於近日收到WHO關於出口製劑車間GMP現場審計通過的通知。
WHO的GMP審計是基於對左氧氟沙星片製劑生產相關的六大系統進行的,審計時間為2020年1月13日至2020年1月17日。近日,公司收到了WHO簽發的審計關閉證書,意味着公司通過了WHO此次對公司基於相關製劑生產線的GMP現場審計。
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