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中關村(000931.SZ):下屬公司北京華素聯苯苄唑原料藥獲批上市
格隆匯 04-22 15:56

格隆匯4月22日丨中關村(000931.SZ)公佈,北京中關村科技發展(控股)股份有限公司(以下簡稱:公司)下屬公司北京華素製藥股份有限公司(以下簡稱:北京華素)“聯苯苄唑原料藥”於近日通過國家藥品監督管理局藥品審評中心(以下簡稱:CDE)技術審評,並獲得國家藥品監督管理局(以下簡稱:國家藥監局)核准簽發的《化學原料藥上市申請批准通知書》。

聯苯苄唑原料藥適應症為抗真菌感染。聯苯苄唑(Bifonazole)由德國拜爾公司研究開發,1983年在德國首次上市,其後在日、法、英、意、比利時先後上市應用。目前CDE原輔包登記信息平台顯示,聯苯苄唑原料藥共5家,4家狀態為“A”,1家狀態為“I”。北京華素為第4家轉“A”的企業。國家藥監局藥品信息檢索顯示聯苯苄唑有63個製劑批文。根據藥智網原料藥用量數據顯示,聯苯苄唑原料藥近6年平均用量約為3噸。

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