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陕西省药品监督管理局关于对陕西步长制药有限公司等药品生产企业药品GMP符合性检查结果的通告
Core Viewpoint - The announcement from the Shaanxi Provincial Drug Administration details the results of GMP compliance inspections for three pharmaceutical companies, indicating varying levels of compliance with regulatory standards [2] Group 1: Company Compliance Results - Shaanxi Buchang Pharmaceutical Co., Ltd. was found to be compliant with GMP requirements during inspections conducted from September 16 to September 19, 2025, covering tablet production lines [2] - Xi'an Boai Pharmaceutical Co., Ltd. was found to be non-compliant with GMP requirements during inspections conducted from October 13 to October 17, 2025, focusing on raw material production lines [2] - Shaanxi Fujie Pharmaceutical Co., Ltd. was found to be compliant with GMP requirements during inspections conducted from October 28 to November 1, 2025, covering multiple production lines for raw materials [2]
山东步长制药股份有限公司 关于为公司全资子公司提供担保的公告
Group 1 - Company provided a guarantee of 80 million RMB for its wholly-owned subsidiary, Shaanxi Buchang Pharmaceutical Co., Ltd., in a loan agreement with Huaxia Bank [2][7] - The board approved a total financing limit of up to 6.92 billion RMB for 2025, with specific guarantee limits for subsidiaries based on their debt ratios [3][12] - As of the announcement date, the total amount of guarantees provided by the company and its subsidiaries was 2.296 billion RMB, accounting for 22.48% of the company's audited net assets as of the end of 2024 [14] Group 2 - The company’s wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., signed a contract with Beijing Excellent Future International Pharmaceutical Technology Development Co., Ltd. for clinical trials of a new drug [17] - The total cost for the clinical trial is 60.338 million RMB, covering 480 cases, with provisions for adjustments based on the final sample size [19] - This contract is expected to enhance the company's drug research and development capabilities, potentially saving time and costs in clinical trials [34] Group 3 - The company’s subsidiary, Shaanxi Buchang, received approval for changes to its drug production license, allowing for the addition of a new production line for tablets [42] - The changes are anticipated to optimize production structure and maintain stable production capacity to meet market demand [43]
步长制药:陕西步长药品生产许可证变更
Core Viewpoint - Company has received a new drug production license from the Shaanxi Provincial Drug Administration, allowing for the expansion of its production capabilities and self-manufacturing of certain products, which is expected to positively impact future operations [1] Group 1: License and Production Changes - The company’s subsidiary, Shaanxi Buchang, has obtained a revised drug production license from the Shaanxi Provincial Drug Administration [1] - The license change includes the addition of a tablet production line at the company’s facility located at 16 Buchang Road, Qindu District, Xianyang City, Shaanxi Province [1] - The production of Phosphate Sitagliptin Tablets, previously contracted to Shandong Danhong Pharmaceutical Co., Ltd., will now be produced in-house following compliance with GMP standards [1] Group 2: Impact on Operations - The changes are expected to optimize the company's production structure, ensuring stable production capacity to meet market demand [1] - The overall impact of these changes is anticipated to be positive for the company's future operations [1]