華海藥業(600521.SH):美國FDA關閉公司川南原料藥生產基地警吿信
格隆匯11月8日丨華海藥業(600521.SH)公佈,公司於2018年12月1日披露了關於美國食品藥品監督管理局(“FDA”)對公司川南原料藥生產基地檢查出具警吿信的公吿。
近日,公司收到FDA關於警吿信關閉的通知函,該警吿信關閉的通知函吿知:FDA已完成公司針對警吿信遞交的整改措施的審評。基於審評結果,FDA認為公司已解決了警吿信中提及的相關問題。
上述警吿信主要涉及的範圍為公司川南原料藥生產基地,涉及原料藥29個產品。因同時受2018年9月美國進口禁令的影響,到目前為止公司臨海川南生產基地生產的原料藥產品以及使用川南生產基地生產的原料藥製成的製劑產品均沒有出口到美國。
此次FDA關閉公司川南原料藥生產基地警吿信,將有利於公司美國市場的禁令解除和銷售的逐步恢復,同時對公司新產品的獲批將起到積極的作用,有利於提振公司的業績。
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