兄弟科技(002562.SZ):目前碘海醇、碘帕醇原料藥處於審評階段,公司尚未開展GMP符合性檢查工作
格隆匯9月8日丨有投資者於投資者互動平台向兄弟科技(002562.SZ)提問,“據江西藥監局官網顯示,貴公司江西工廠碘造影劑項目於23年6月之前分別接受了多次gmp符合性檢查,截止23年9月尚未通過gmp符合性檢查,貴公司造影劑項目實施至今已經7-8年時間,遠遠長於國內同行的平均3-5年即可獲證的平均時間。請問,貴公司是否具備原料藥項目實施的基本技術能力和項目管控能力?”
兄弟科技(002562.SZ)回覆稱,目前碘海醇、碘帕醇原料藥處於審評階段,公司尚未開展GMP符合性檢查工作;碘造影劑項目於2020年第四季度正式投產,公司將加快推進碘造影劑原料藥批件的申報工作,後續進展敬請留意公司披露的相關公吿。
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