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聯環藥業(600513.SH):馬來酸氯苯那敏原料藥獲批上市
格隆匯 02-09 17:09

格隆匯2月9日丨聯環藥業(600513.SH)公佈,近日,公司收到國家藥品監督管理局頒發的關於原料藥馬來酸氯苯那敏的《化學原料藥上市申請批准通知書》。

馬來酸氯苯那敏是烷基胺類抗變態反應藥,其主要用於皮膚過敏症蕁麻疹、濕疹、皮炎、藥疹、皮膚瘙癢症、神經性皮炎、蟲咬症、日光性皮炎,也可用於過敏性鼻炎,藥物及食物過敏。目前,馬來酸氯苯那敏原料藥國內其他生產廠家主要有河南九勢製藥股份有限公司、上海新華聯製藥有限公司、上海現代哈森(商丘)藥業有限公司、四川迪菲特藥業有限公司、雲鵬醫藥集團有限公司等。2021年馬來酸氯苯那敏原料藥國內用量約150.76噸(數據來源於藥融雲數據庫)。

公司於2020年12月24日向國家藥品監督管理局提交馬來酸氯苯那敏原料藥技術審評申請,近日獲得國家藥品監督管理局下發的《化學原料藥上市申請批准通知書》。該原料藥在CDE原輔包登記信息平台上顯示狀態為“A”。

截至公吿日,公司用於馬來酸氯苯那敏原料藥研發投入累計約人民幣521.55萬元(未經審計)。

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