药品GMP符合性

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华润双鹤控股子公司浙江新赛科通过GMP符合性检查
Zhi Tong Cai Jing· 2025-09-02 09:45
Core Viewpoint - China Resources Double Crane (600062.SH) announced that its subsidiary, Zhejiang Xinsai Pharmaceutical Co., Ltd., received a GMP compliance inspection notice from the Zhejiang Provincial Drug Administration for the raw materials of Fenofibrate and Azilsartan [1] Group 1 - The successful GMP compliance inspection indicates that the company's production quality management meets GMP requirements [1] - This achievement will help the company maintain stable product quality and continuous production capacity [1] - The company aims to meet the market demand for related pharmaceuticals [1]
突发公告!重要子公司被罚停产,这家A股公司触发ST情形
21世纪经济报道· 2025-04-24 14:56
Core Viewpoint - Unimed Pharmaceutical's subsidiary, Tianjin Unimed Biopharmaceutical Co., has been suspended from production and sales due to non-compliance with GMP standards, which may significantly impact the company's operations and could lead to further risk warnings if production does not resume within three months [1][6]. Financial Performance - In 2024, Tianjin Unimed generated revenue of 217 million yuan and a net profit of -14.0037 million yuan, accounting for 60.09% of Unimed's total revenue and 9.8% of its consolidated net profit [4]. - Unimed's 2024 annual report indicated a total revenue of 360 million yuan, a year-on-year decrease of 16.14%, and a net loss of 137 million yuan, with losses widening by 58.70% compared to the previous year [8]. Regulatory Actions - The suspension was initiated following a GMP compliance inspection by the Tianjin Municipal Drug Administration, which found that Tianjin Unimed's production practices did not meet the required standards [5][6]. - In response, Unimed has established a special rectification team to identify issues and develop a corrective action plan while cooperating with regulatory authorities to address deficiencies [7]. Market Reaction - Following the announcement, Unimed's stock price fell by 2.49%, closing at 8.24 yuan per share, with a total market capitalization of 5.436 billion yuan [9].
突发公告!重要子公司被罚停产,这家上市药企或触发ST情形
2 1 Shi Ji Jing Ji Bao Dao· 2025-04-24 14:11
关于应对措施,未名医药公告表示,公司已成立专项整改小组,全面排查问题根源,制定整改方案,并 积极配合监管部门完成缺陷整改工作,争取尽快恢复生产。 公开资料显示,未名医药主营业务为为干扰素、神经生长因子、生物医药CRO/CDMO、疫苗和医药中 间体等五大生物医药板块,公司重点发展人干扰素α2b系列产品,主要产品捷抚-重组人干扰素α2b喷雾 剂(假单胞菌),是全球第一支干扰素喷雾剂。其子公司天津未名是我国率先进入基因工程制药产业化 领域的企业之一。 4月23日晚,未名医药披露了2024年年报。财报显示,公司去年实现营业收入3.60亿元,同比减少 16.14%;归母净利润-1.37亿元,亏损同比扩大58.70%。 截至今日收盘,未名医药下跌2.49%,最新价报8.24元/股,总市值达54.36亿元。 (声明:文章内容仅供参考,不构成投资建议。投资者据此操作,风险自担。) 4月24日晚间,未名医药(002581.SZ)突发公告称,公司控股子公司天津未名生物医药有限公司(简 称"天津未名")于4月22日被天津市药品监督管理局采取暂停生产、销售风险控制措施。 未名医药表示,天津未名为公司重要子公司,本次暂停生产、销售事项 ...