吡格列酮二甲双胍片(15mg/500mg)
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北陆药业:吡格列酮二甲双胍片(15mg/500mg)获批上市
Zheng Quan Ri Bao Wang· 2025-12-12 13:12
证券日报网讯12月12日晚间,北陆药业(300016)发布公告称,近日公司收到国家药品监督管理局核准 签发的吡格列酮二甲双胍片(15mg/500mg)的《药品注册证书》,按照化学药品3类获批,视同通过仿制 药质量和疗效一致性评价。 ...
北陆药业:吡格列酮二甲双胍片获得药品注册证书
Xin Lang Cai Jing· 2025-12-12 07:57
Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug Pioglitazone Metformin Tablets (15mg/500mg), enhancing its diabetes medication product line and market competitiveness [1] Group 1: Product Approval - The Pioglitazone Metformin Tablets (15mg/500mg) have been approved as a Class 3 chemical drug, indicating it has passed the consistency evaluation for generic drug quality and efficacy [1] - This approval allows the company to expand its diabetes treatment offerings, which is expected to strengthen its position in the market [1] Group 2: Market Strategy - The company plans to actively prepare for the launch of the new product and aims to bring it to market as soon as possible [1] - There may be uncertainties affecting the production and sales of the new product, which the company will need to navigate [1]