Workflow
哌拉西林钠
icon
Search documents
华北制药(600812.SH):全资子公司通过药品GMP符合性检查
Ge Long Hui A P P· 2026-01-23 09:01
Core Viewpoint - North China Pharmaceutical Group's subsidiary, North China Pharmaceutical Group Shentai Pharmaceutical Co., Ltd., has received a GMP compliance inspection notice from the Hebei Provincial Drug Administration for its product, Piperacillin Sodium, which is used to treat infections caused by Pseudomonas aeruginosa and other sensitive Gram-negative bacteria [1]. Group 1 - The product name is Piperacillin Sodium, which is primarily indicated for pneumonia, sepsis, respiratory, biliary, and urinary tract infections, as well as subacute endocarditis and purulent meningitis [1].
华北制药:全资子公司通过药品GMP符合性检查
Xin Lang Cai Jing· 2026-01-23 08:47
Core Viewpoint - North China Pharmaceutical announced that its wholly-owned subsidiary, North China Pharmaceutical Group Xiantai Pharmaceutical Co., Ltd., received a GMP compliance inspection notice from the Hebei Provincial Drug Administration for its sterile active pharmaceutical ingredient (API) production line [1] Group 1 - The inspection scope includes the sterile API (Piperacillin Sodium) production line 2 of the freeze-drying workshop 802 [1] - The inspection is scheduled from December 9 to December 12, 2025, and the conclusion indicates compliance with the Good Manufacturing Practice (GMP) requirements as per the 2010 revision [1] - The annual production capacity of the freeze-drying production line 2 is 150 tons, with a total investment of 74.5744 million yuan [1] Group 2 - This inspection marks the first GMP compliance check following the registration and filing of the newly added freeze-drying production line for Piperacillin Sodium [1]