北陸藥業(300016.SZ):瑞格列奈原料藥獲得上市申請批准通知書
格隆匯9月29日丨北陸藥業(300016.SZ)公佈,近日,公司瑞格列奈原料藥收到國家藥品監督管理局核准簽發的《化學原料藥上市申請批准通知書》(通知書編號:2022YS00091)。
瑞格列奈原料藥可用於生產瑞格列奈片。瑞格列奈片為短效胰島素促泌劑,通過促進胰腺釋放胰島素來降低血糖水平,可快速模擬胰島素早相分泌,起效快;能夠全面控制餐後及空腹血糖,單藥或聯合二甲雙胍均有理想的降糖效果;具有很好的心血管保護作用;低血糖發生率低,無體重增加風險,無腎臟禁忌症。
公司表示,該次瑞格列奈原料藥獲得上市申請批准通知書表明該原料藥已符合國家相關藥品審評技術標準,為公司瑞格列奈片今後參加國家藥品集中採購創造有利條件。
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