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華海藥業(600521.SH):奈必洛爾片獲得美國FDA批准文號
格隆匯 04-10 16:23

格隆匯4月10日丨華海藥業(600521.SH)公佈,近日,公司收到美國食品藥品監督管理局(“美國FDA”)的通知,公司向美國FDA申報的奈必洛爾片的新藥簡略申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。

奈必洛爾片主要用於治療高血壓。奈必洛爾片由Allergan研發,最早於2008年在美國上市。當前,美國境內,奈必洛爾片的主要生產廠商有ANI、Ascend、Camber等。2021年該藥品美國市場銷售額約2367.10萬美元(數據來源於IMS數據庫)。

截至目前,公司在奈必洛爾片項目上已投入研發費用約1073萬元人民幣。

此次奈必洛爾片ANDA文號的獲批標誌着公司具備了在美國市場銷售該產品的資格,該產品ANDA文號的獲取有利於公司不斷擴大美國市場銷售,強化產品供應鏈,豐富產品梯隊,提升公司產品的市場競爭力,對公司的經營業績產生積極的影響。

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