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一品紅(300723.SZ):鹽酸文拉法辛緩釋膠囊獲批
格隆匯 08-15 17:40

格隆匯8月15日丨一品紅(300723.SZ)公佈,公司全資子公司廣州一品紅製藥有限公司近日收到國家藥監局核准簽發的關於鹽酸文拉法辛緩釋膠囊的《藥品註冊證書》。根據核准的藥品説明書,公司獲批的鹽酸文拉法辛緩釋膠囊用於治療抑鬱症(包括伴有焦慮的抑鬱症)及廣泛性焦慮障礙。

公司獲批的鹽酸文拉法辛緩釋膠囊是以化學藥品4類申報註冊,視同通過仿製藥一致性評價;目前公司擁有該品75mg和150mg雙規格。鹽酸文拉法辛緩釋膠囊屬於國家醫保甲類產品,國家基藥品種。米內網數據顯示,2021年文拉法辛在中國城市公立醫院、縣終端銷售額達12.52億元。

公司表示,此次獲得鹽酸文拉法辛緩釋膠囊註冊證書,標誌着公司具備了在國內市場生產銷售該藥品的資格,將進一步豐富了公司銷售產品管線和品類,增強公司在慢病藥領域的競爭力。

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