健友股份(603707.SH)獲美國肝素鈉注射液USP藥品註冊批件
格隆匯2月26日丨健友股份(603707.SH)公佈,公司於近日收到美國食品藥品監督管理局(以下簡稱“美國FDA”)簽發的肝素鈉注射液USPANDA批准通知(ANDA號:211004)。
肝素鈉注射液USP主要用於抗凝、抗血栓等症狀的治療,用於防治血栓形成或栓塞性疾病(如心肌梗塞、血栓性靜脈炎、肺栓塞等);各種原因引起的瀰漫性血管內凝血(DIC);也用於血液透析、體外循環、導管術、微血管手術等操作中及某些血液標本或器械的抗凝處理。截至目前,公司在肝素鈉注射液USP研發項目上已投入研發費用約人民幣2644.21萬元。
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