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天士力(600535.SH):吲达帕胺片通过仿制药一致性评价
格隆汇 01-14 17:18

格隆汇1月14日丨天士力(600535.SH)公布,近日,公司控股子公司天津天士力(辽宁)制药有限责任公司(以下简称“辽宁天士力”)收到国家药品监督管理局颁发的关于吲达帕胺片2.5mg规格的《药品补充申请批件》(批件号:2020B02108),该药品通过仿制药一致性评价。

吲达帕胺片为磺胺类利尿剂,具有利尿和钙拮抗作用,是一种强效、长效的降压药,临床上主要用于治疗原发性高血压。根据PDB药物综合数据库数据显示,吲达帕胺片2018年在全球销售额为8.19亿美元,同比上涨3.80%。经查询,中国境内已上市的吲达帕胺片生产企业主要有天津力生制药股份有限公司、施维雅(天津)制药有限公司(原研)等。截至公告日,辽宁天士力针对该药品一致性评价已投入研发费用约为748.07万元人民币。

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