雙成藥業(002693.SZ):依替巴肽注射液大規格(75mg/100ml)目前已出口美國
格隆匯5月26日丨雙成藥業(002693.SZ)於2023年5月26日下午14:30-17:00召開業績説明會,問答環節中,就“公司2022年4月披露的依替巴肽在美國獲批的情況”,公司回覆稱,2022年4月披露的品種是依替巴肽注射液大規格(75mg/100ml)。該品種於2021年10月底向美國FDA遞交了sANDA的申請。由於旅行限制,美國FDA無法來公司進行現場檢查,但基於公司多年來建立的GMP規範化的良好記錄,FDA於2022年4月批准了該產品,該品種目前已出口美國。
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