富马酸福莫特罗

Search documents
津药药业股份有限公司 关于收到药品GMP符合性检查结果的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-07-31 23:22
近日,津药药业股份有限公司(以下简称"公司")收到天津市药品监督管理局签发的《药品GMP符合 性检查告知书》(编号:2025011),现将相关信息公告如下: 一、 基本情况 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担个别及连带责任。 (二)涉及主要产品的市场情况 ■ 企业名称:津药药业股份有限公司 检查地址:天津开发区西区新业九街19号 检查范围:1.原料药(泼尼松),生产车间:107车间,生产线:泼尼松生产B线;2.原料药(甲泼尼龙),生产 车间:113车间,生产线:甲泼尼龙生产B线;3.原料药(氢化可的松琥珀酸钠),生产车间:106车间,生产 线:氢化可的松琥珀酸钠生产线;4.原料药(富马酸福莫特罗),生产车间:108车间,生产线:富马酸福莫特 罗生产线。 检查时间:2025年05月13日-2025年05月16日 检查依据:《药品生产质量管理规范》(2010年修订) 检查结论:符合要求 二、其他相关情况 (一)本次检查所涉及生产线及主要产品情况 ■ 注: 1.以上部分数据来源为国家药品监督管理局官方网站; 2.上述统计结果可能不 ...
津药药业:收到药品GMP符合性检查结果
Mei Ri Jing Ji Xin Wen· 2025-07-31 09:13
Core Viewpoint - Tianjin Pharmaceutical Industry (津药药业) has received a GMP compliance inspection notice from the Tianjin Drug Administration, indicating that its production facilities for certain raw materials meet regulatory requirements, which is expected to support stable production capacity and leverage the integrated advantages of raw materials and formulations [2] Group 1 - The company received a GMP compliance inspection notice for its production facilities related to raw materials including prednisone, methylprednisolone, hydrocortisone sodium succinate, and formoterol fumarate [2] - The inspection concluded that the production facilities meet the required standards, which is beneficial for maintaining stable production capacity [2] - The integrated advantages of raw materials and formulations will help the company meet market demand [2] Group 2 - Future sales of the products may be influenced by changes in the market environment, indicating potential uncertainties [2]