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普利製藥(300630.SZ):硝普鈉注射液獲批上市
格隆匯 04-17 17:08

格隆匯4月17日丨 普利製藥(300630.SZ)公佈,公司於近日收到國家藥品監督管理局簽發的硝普鈉注射液的藥品註冊批件。

硝普鈉注射液是一種血管擴張劑,主要用於:高血壓危象中立即降低成人和兒科患者的血壓;手術期間控制血壓以減少出血;治療急性充血性心力衰竭。

公司成功研發硝普鈉注射液仿製藥後,相繼提交了國內外多個國家的註冊申請,同時該品種也是公司原料製劑一體化品種。該產品於2020年8月獲得美國FDA批准,於2020年10月獲得加拿大衞生部批准。近日,公司收到國家藥品監督管理局的批准通知,關聯審評審批原料藥(登記號Y20190000020)登記狀態已轉為 A

公司硝普鈉注射液以化學藥品新註冊分類3類獲批上市,標誌着此產品視同通過仿製藥注射劑一致性評價,作為國內獨家劑型,自產原料,對普利製藥意義非凡,不僅有利於提升該藥品的市場競爭力,而且對公司的經營業績也將產生積極影響。

公司的硝普鈉注射液在德國等其他市場的註冊工作仍在持續推進中。

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