人福醫藥(600079.SH):宜昌人福鹽酸文拉法辛緩釋膠囊獲美國FDA批准文號
格隆匯8月9日丨人福醫藥(600079.SH)宣佈,近日,公司控股子公司宜昌人福藥業有限責任公司(簡稱“宜昌人福”,公司持有其80%的股權)收到美國食品藥品監督管理局(FDA)關於鹽酸文拉法辛緩釋膠囊的批准文號。
鹽酸文拉法辛緩釋膠囊適用於各種類型抑鬱症,包括伴有焦慮的抑鬱症及廣泛性焦慮症。宜昌人福於2020年提交鹽酸文拉法辛緩釋膠囊的ANDA申請,累計研發投入約為200萬美元。
根據IQVIA數據統計,2020年度鹽酸文拉法辛緩釋膠囊在美國市場的總銷售額約為2億美元,主要生產廠商有Aurobindo、Zydus和Teva等。根據米內網數據統計,2020年度文拉法辛所有劑型在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為12億元人民幣,主要生產廠商包括成都康弘藥業集團股份有限公司、Pfizer Healthcare Ireland、北京福元醫藥股份有限公司等。
該次鹽酸文拉法辛緩釋膠囊獲得美國FDA批准文號標誌着宜昌人福具備了在美國市場銷售該產品的資格,將對公司拓展美國仿製藥市場帶來積極的影響,公司後續將積極推進該產品在美國市場的上市準備工作。
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