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上海现代制药股份有限公司关于药品通过仿制药一致性评价的自愿性信息披露公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:600420 证券简称:国药现代 公告编号:2025-042 上海现代制药股份有限公司 剂型:片剂(薄膜衣) 规格:0.25g 注册分类:化学药品 关于药品通过仿制药一致性评价的 自愿性信息披露公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担法律责任。 近日,上海现代制药股份有限公司(以下简称公司)及全资子公司国药集团容生制药有限公司(以下简 称国药容生)分别收到国家药品监督管理局核准签发的《药品补充申请批准通知书》。现将相关情况公 告如下: 一、阿奇霉素片 (一)药品基本信息 药品名称:阿奇霉素片 通知书编号:2025B02440 原药品批准文号:国药准字H20000477 上市许可持有人:上海现代制药股份有限公司 药品生产企业:上海现代制药股份有限公司 审批结论:根据《中华人民共和国药品管理法》、《国务院关于改革药品医疗器械审评审批制度的意 见》(国发〔2015〕44号)和《关于仿制药质量和疗效一致性评价工作有关事项的公告》(2017年第 100号)规定,经审查,本品通 ...
国药现代:阿奇霉素片和二羟丙茶碱注射液通过仿制药一致性评价
news flash· 2025-06-04 09:10
Core Viewpoint - The company and its wholly-owned subsidiary have received approval for two generic drugs, which is expected to enhance market expansion and sales opportunities [1] Group 1: Drug Approvals - The company received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration for Azithromycin Tablets and Dihydrocodeine Injection [1] - Both drugs have passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 2: Market Potential - Azithromycin Tablets are indicated for infections caused by sensitive bacteria, with projected sales of 685 million yuan in public medical institutions and urban pharmacies in 2024 [1] - Dihydrocodeine Injection is used for treating bronchial asthma, with expected sales of 135 million yuan in public medical institutions in 2024 [1] - The successful evaluation is beneficial for product market expansion and sales [1]