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CN

喜讯 | 普洛药业盐酸安非他酮缓释片取得药品注册证书

author： Aperoa
2023.Oct.13

近日，普洛药业收到国家药品监督管理局核准签发的盐酸安非他酮缓释片(Ⅱ)《药品注册证书》。该产品以化学药品4类申报获批，视同通过仿制药一致性评价。

盐酸安非他酮缓释片(Ⅱ)用于治疗抑郁症。据米内网数据显示，安非他酮2021年和2022年在国内城市公立医院、城市社区、县级公立医院及乡镇卫生院终端销售金额分别为7265万元和9008万元。根据相关零售数据系统分析，安非他酮2021年和2022年在零售市场的销售金额分别为152万元和221万元。
该产品是采用中美双报的策略布局，并具备原料药+制剂一体化的竞争优势。该注册证书的取得标志着公司该产品具备了在国内市场销售的资格，丰富了公司缓控释制剂产品管线，更好地为患者提供高品质的药品，对公司未来经营发展具有一定的积极作用。

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