Workflow
药品GMP符合性
icon
Search documents
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
Core Viewpoint - Unimed Pharmaceutical announced a significant impact on its operations due to the suspension of production and sales at its subsidiary Tianjin Unimed Biopharmaceutical Co., Ltd. by the Tianjin Drug Administration, which may lead to further risk warnings if production does not resume within three months [1] Group 1: Company Operations - Tianjin Unimed is a key subsidiary of Unimed Pharmaceutical, primarily engaged in the production and sales of interferon drugs [1] - The company reported that Tianjin Unimed generated revenue of 217 million yuan in 2024, accounting for 60.09% of Unimed's total revenue, and contributed a net loss of 14.0037 million yuan, representing 9.8% of the consolidated net profit [1] - The suspension was due to non-compliance with the Good Manufacturing Practice (GMP) requirements as assessed during an inspection by the Tianjin Drug Administration [1] Group 2: Financial Performance - Unimed Pharmaceutical's 2024 annual report indicated a 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 [2] Group 3: Market Reaction - Following the announcement, Unimed Pharmaceutical's stock price fell by 2.49%, closing at 8.24 yuan per share, with a total market capitalization of 5.436 billion yuan [3]