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金城医药(300233.SZ):子公司收到药品GMP符合性检查告知书
Ge Long Hui A P P· 2025-12-30 14:46
Core Viewpoint - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Tail Pharmaceutical Co., Ltd., has received the GMP compliance inspection notice for the active pharmaceutical ingredient Mirabegron, allowing for domestic production and sales [1] Group 1: Company Developments - The approval from the Beijing Drug Administration signifies that the Mirabegron active pharmaceutical ingredient has passed the GMP compliance inspection, which is based on the 2010 revised Drug Production Quality Management Standards [1] - This achievement enhances the variety of products offered by the company and is expected to improve its competitiveness in the chemical raw material drug sector [1] - Jincheng Tail will proceed with production in accordance with relevant requirements and market demand [1]
金城医药:子公司申报的米拉贝隆原料药已通过GMP符合性检查
Xin Lang Cai Jing· 2025-12-30 13:20
Core Viewpoint - Jincheng Pharmaceutical's wholly-owned subsidiary, Beijing Jincheng Tail Pharmaceutical Co., Ltd., has received the GMP compliance inspection notice from the Beijing Drug Administration for its active pharmaceutical ingredient, Mirabegron, indicating successful compliance with the 2010 revised Good Manufacturing Practice standards [1] Group 1 - The inspection took place from December 11 to 15, 2023 [1] - The scope of the inspection covered the Mirabegron production line in the second workshop [1] - The inspection conclusion confirmed that the company met the relevant standards and appendix requirements [1]
金城医药:子公司获米拉贝隆原料药上市批准
Di Yi Cai Jing· 2025-09-23 08:16
Core Viewpoint - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Tail Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing of Mirabegron active pharmaceutical ingredient, enhancing the company's product line and market competitiveness [1] Summary by Relevant Sections - **Approval Announcement** - The company announced that it has received the approval notice for the marketing application of Mirabegron active pharmaceutical ingredient [1] - **Product Information** - Mirabegron is a selective β-3 adrenergic receptor agonist primarily used for the treatment of overactive bladder [1] - **Market Data** - According to IMS data, the global consumption of Mirabegron active pharmaceutical ingredient is projected to be 57.91 tons in 2022, 63.05 tons in 2023, and 69.79 tons in 2024 [1] - **Strategic Implications** - The approval will enrich the company's active pharmaceutical ingredient product line and enhance its market competitiveness [1]