白云山(00874)分公司收到化学原料药上市申请批准通知书

智通财经
Yesterday

智通财经APP讯,白云山(00874)发布公告,近日,广州白云山医药集团股份有限公司(以下简称“本公司”)分公司广州白云山医药集团股份有限公司白云山化学制药厂(以下简称 “白云山化学制药厂”) 收到国家药品监督管理局(以下简称“国家药监局”)签发的阿托伐他汀钙《化学原料药上市申请批准通知书》。

阿托伐他汀钙为羟甲基戊二酰辅酶 A(HMG-CoA)还原酶抑制剂。主要通过抑制 HMGCoA 还原酶的合成,从而抑制体内胆固醇的合成,降低血清低密度脂蛋白胆固醇、甘油三酯的含量。主要适应症为原发性高胆固醇血症、混合型高脂血症、高甘油三酯血症、纯合子家族性高胆固醇血症及防治动脉粥样硬化。

经查询,目前国内阿托伐他汀钙原料药的主要生产厂家有齐鲁制药有限公司、天方药业有限公司、宜昌东阳光长江药业股份有限公司等。根据米内网数据显示,2023 年阿托伐他汀钙片在中国公立医院和零售药店的销售额为人民币 637,474 万元。

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