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永太科技(002326.SZ):永太藥業取得磷酸西格列汀的化學原料藥上市申請批准通知書
格隆匯 08-01 16:47

格隆匯8月1日丨永太科技(002326.SZ)公佈,公司的子公司浙江永太藥業有限公司(簡稱“永太藥業”)於近日收到國家藥品監督管理局頒發的關於磷酸西格列汀的《化學原料藥上市申請批准通知書》(通知書編號:2023YS00528)。

磷酸西格列汀是由默沙東公司研製開發的一種二肽基肽酶-4(DPP-4)抑制劑,於2006年10月首次在美國批准,用於改善2型糖尿病患者的血糖控制。永太藥業磷酸西格列汀原料藥通過國家藥品監督管理局藥品審評中心(以下簡稱“CDE”)技術審評,在CDE原料藥、藥用輔料和藥包材登記信息公示平台上顯示登記號轉為“A”(已批准在上市制劑中使用的原料)狀態。

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