米拉贝隆原料药
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金城医药(300233.SZ):子公司收到药品GMP符合性检查告知书
Ge Long Hui A P P· 2025-12-30 14:46
格隆汇12月30日丨金城医药(维权)(300233.SZ)公布,全资子公司北京金城泰尔制药有限公司(简 称"金城泰尔")收到北京市药品监督管理局核准签发的《药品GMP符合性检查告知书》(京药监药 GMP〔2023〕020113),其申报的米拉贝隆原料药已通过《药品生产质量管理规范(2010年修订)》 符合性检查(简称"GMP符合性检查")。本次《药品GMP符合性检查告知书》的获得,标志着米拉贝 隆原料药可以在国内生产并上市销售。本次获得药品GMP符合性检查告知书丰富了公司产品种类,有 利于提升在化学原料药领域的市场竞争力。金城泰尔将按照相关要求和市场需求开展生产。 ...
金城医药:子公司申报的米拉贝隆原料药已通过GMP符合性检查
Xin Lang Cai Jing· 2025-12-30 13:20
金城医药公告,全资子公司北京金城泰尔制药有限公司收到北京市药品监督管理局核准签发的《药品 GMP符合性检查告知书》,其申报的米拉贝隆原料药已通过《药品生产质量管理规范(2010年修 订)》符合性检查。检查时间为2023年12月11日至15日,检查范围为米拉贝隆原料药(二车间米拉贝隆 生产线)。检查结论显示,该企业此次检查范围符合相关规范和附录要求。 ...
金城医药:子公司获米拉贝隆原料药上市批准
Di Yi Cai Jing· 2025-09-23 08:16
Core Viewpoint - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Tail Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing of Mirabegron active pharmaceutical ingredient, enhancing the company's product line and market competitiveness [1] Summary by Relevant Sections - **Approval Announcement** - The company announced that it has received the approval notice for the marketing application of Mirabegron active pharmaceutical ingredient [1] - **Product Information** - Mirabegron is a selective β-3 adrenergic receptor agonist primarily used for the treatment of overactive bladder [1] - **Market Data** - According to IMS data, the global consumption of Mirabegron active pharmaceutical ingredient is projected to be 57.91 tons in 2022, 63.05 tons in 2023, and 69.79 tons in 2024 [1] - **Strategic Implications** - The approval will enrich the company's active pharmaceutical ingredient product line and enhance its market competitiveness [1]