【天宇股份：全资子公司原料药通过CDE审评】金十数据2月24日讯，天宇股份公告称，公司全资子公司浙江京圣药业有限公司的甲苯磺酸艾多沙班原料药于近日通过国家药品监督管理局药品审评中心审评。该药品用于非瓣膜性房颤成人患者预防卒中和体循环栓塞，以及成人深静脉血栓和肺栓塞的治疗和预防复发。甲苯磺酸艾多沙班原料药现已通过CDE审评，但还需取得浙江省药品监督管理局GMP符合性检查结果为“符合要求”的公示后，方可在国内上市销售。目前国内获得CDE技术审评通过的厂家有6家。由于市场环境变化等因素影响，该原料药的国内上市销售时间尚存在不确定性。
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