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羅欣藥業(002793.SZ):羅欣安若維他通過美國FDA現場檢查
格隆匯 07-17 18:15

格隆匯7月17日丨羅欣藥業(002793.SZ)公佈,公司下屬控股子公司羅欣安若維他藥業(成都)有限公司(以下簡稱“羅欣安若維他”)於2023年8月3日11日期間接受了美國食品藥品監督管理局(以下簡稱“FDA”)的CGMP(即現行藥品生產質量管理規範)現場檢查。近日,羅欣安若維他收到了美國FDA簽發的現場檢查報吿(EIR,Establishment Inspection Report),確認本次檢查已完成並通過現場檢查。

鹽酸左旋沙丁胺醇是一種腎上腺素β受體激動劑,為沙丁胺醇左旋體,其中左旋體產生舒張支氣管平滑肌的作用。臨牀上用於治療或預防可逆性氣道阻塞性疾病引起的支氣管痙攣。

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