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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
Core Points - The company received a GMP compliance inspection notice from the Tianjin Municipal Drug Administration, indicating that its production lines meet regulatory requirements [1][2] - The inspection covered multiple active pharmaceutical ingredients (APIs) including Prednisone, Methylprednisolone, Hydrocortisone Sodium Succinate, and Formoterol Fumarate, with specific production lines and workshops identified [1] - The inspection is scheduled from May 13 to May 16, 2025, and is based on the 2010 revision of the Drug Production Quality Management Standards [1] Company Impact - The receipt of the GMP compliance notice is expected to support the company's stable production capacity and leverage its integrated advantages in APIs and formulations to meet market demand [2] - The future sales performance of the products may be influenced by market environment changes, indicating potential uncertainties in the pharmaceutical market [2]
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]