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山东步长制药股份有限公司关于公司获得药品补充申请批准通知书的公告
Shang Hai Zheng Quan Bao· 2025-11-14 19:27
Group 1 - Company has received the approval notice for the supplementary application of the drug "Xiaolin Baidu San" from the National Medical Products Administration [1] - "Xiaolin Baidu San" is a unique product of the company, primarily used for clearing heat and detoxifying, and treating symptoms related to urinary tract infections [1] - The company has invested approximately 28.15 million RMB in research and development for "Xiaolin Baidu San" and its pill form [1] Group 2 - The company has obtained a change in its drug production license from the Shandong Provincial Drug Administration, allowing for the addition of workshops, production lines, and production scope [4] - The production license now includes the addition of a comprehensive preparation workshop for pill production, enhancing the company's production capabilities [5] - The extension of the entrusted production validity period for various medications will help maintain stable production capacity and meet market demand [6]
步长制药(603858.SH):公司药品生产许可证变更
Ge Long Hui A P P· 2025-11-14 09:45
Core Viewpoint - Company has received approval from the Shandong Provincial Drug Administration to expand its production capabilities, which is expected to positively impact its future operations [1] Summary by Sections Production License Update - The company has been granted permission to add a new workshop and production line for the production of tablets, specifically in the Heze City location [1] - The new workshop added is the Comprehensive Preparation VI workshop, which will focus on tablet production [1] Contract Manufacturing Extensions - The company has extended its contract manufacturing agreements for various products: - Loratadine tablets and Montelukast chewable tablets until July 16, 2028 - Ibuprofen sustained-release capsules and Ezetimibe tablets until July 16, 2028 - Pregabalin capsules until March 31, 2028 - Donepezil hydrochloride tablets until July 7, 2030 [1] Impact on Operations - The changes in the production license, including the addition of workshops and production lines, are expected to optimize the company's production structure [1] - This will help maintain stable production capacity and meet market demand, leading to a positive impact on the company's future operations [1]
珍宝岛:哈珍宝收到药品补充申请批准通知书
news flash· 2025-04-09 07:48
Core Viewpoint - The announcement indicates that Harbin Zhenbao Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Zhenbao Island (603567), has received approval from the National Medical Products Administration for the transfer of marketing authorization for ten drugs from Anhui Jiuzhou Fangyuan Pharmaceutical Co., Ltd. to Harbin Zhenbao Pharmaceutical Co., Ltd. This change is not expected to have a significant impact on the company's current operating performance [1]. Group 1 - The approval includes the transfer of marketing authorization for ten drugs, which are Olanzapine Tablets, Apixaban Tablets, Escitalopram Oxalate Tablets, Desloratadine Tablets, Voriconazole Tablets, Mecobalamin Tablets, Rivaroxaban Tablets, Valsartan Tablets, and Donepezil Hydrochloride Tablets [1]. - The change in marketing authorization holders is a strategic move for Harbin Zhenbao Pharmaceutical Co., Ltd. to consolidate its product portfolio [1]. - The company emphasizes that this regulatory approval will not materially affect its current financial performance [1].