复星医药(600196.SH):桂林南药阿莫西林胶囊通过仿制药一致性评价
格隆汇12月3日丨复星医药(600196.SH)公布,近日,公司控股子公司桂林南药股份有限公司(以下简称“桂林南药”)收到国家药品监督管理局颁发的关于阿莫西林胶囊的《药品补充申请批件》(批件号:2019B04284),该药品通过仿制药一致性评价。
阿莫西林胶囊片主要用于敏感菌(不产β内酰胺酶菌株)所致的成人与儿童的感染。2018年度,桂林南药阿莫西林胶囊于中国境内(不包括港澳台地区,下同)的销售额约为人民币1245万元(未经审计)。
截至本公告日,于中国境内已上市的阿莫西林制剂主要包括香港联邦制药有限公司的阿莫仙®、山西同达药业有限公司的阿莫西林等。根据IQVIACHPA最新数据(由IQVIA提供,IQVIA是全球领先的医药健康产业专业信息和战略咨询服务提供商),2018年度,阿莫西林制剂于中国境内销售额约为人民币2.28亿元。截至2019年11月,桂林南药现阶段针对该药品一致性评价累计研发投入人民币约655万元(未经审计)。
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