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雙成藥業(002693.SZ):寧波雙成通過美國FDA現場檢查

格隆匯7月31日丨雙成藥業(002693.SZ)公佈,公司的控股子公司寧波雙成藥業有限公司(簡稱“寧波雙成”)於2023年6月5日至2023年6月13日接受了美國食品藥品監督管理局(簡稱“FDA”)的藥品批准前現場檢查,本次CGMP(現行藥品生產質量管理規範)檢查涵蓋在抗腫瘤注射劑一車間生產的三個凍乾粉針劑,分別為公司作為持有人寧波雙成作為生產場地的注射用紫杉醇(白蛋白結合型)和C134,及美國客户SAGENT PHARMACEUTICALS.INC(美國賽進製藥有限公司)作為持有人寧波雙成作為代加工生產場地的注射用環磷酰胺。

公司控股子公司寧波雙成於近日收到美國FDA的通知,該通知已明確寧波雙成通過了此次美國FDA CGMP檢查,寧波雙成的質量管理體系符合美國FDA CGMP的要求。

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