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山东步长制药股份有限公司 关于全资子公司药品生产许可证变更的公告
Group 1 - The company announced that its wholly-owned subsidiary, Baoding Tianhao Pharmaceutical Co., Ltd., received approval from the Hebei Provincial Drug Administration for changes in the production scope and entrusted production situation of its Drug Production License [1] - The production license includes various forms of medications such as ointments, tablets, solutions, and capsules, with the license valid until July 7, 2030 [1] - Changes in production lines include specific formulations such as "Oseltamivir Phosphate Oral Suspension" and "Donepezil Hydrochloride Tablets" [2][3] Group 2 - Baoding Tianhao Pharmaceutical Co., Ltd. has entrusted Shandong Buchang Pharmaceutical Co., Ltd. to produce Donepezil Hydrochloride Tablets, with the entrusted production valid until July 7, 2030 [3] - The changes in the Drug Production License are expected to optimize the production structure and maintain stable production capacity, positively impacting the company's future operations [4]
步长制药:全资子公司药品生产许可证变更
Xin Lang Cai Jing· 2025-08-13 09:19
Core Viewpoint - The announcement indicates that the wholly-owned subsidiary of the company, Baoding Tianhao Pharmaceutical Co., Ltd., has received approval from the Hebei Provincial Drug Administration for changes in its production license, which will positively impact the company's future operations [1] Group 1 - The production license changes include modifications to the production scope for oral suspensions and tablets, as well as shared use of traditional Chinese medicine extraction and granules with Shandong Buchang Shenzhou Pharmaceutical Co., Ltd. [1] - The validity of the new production license is until July 7, 2030, which provides a long-term framework for the company's production capabilities [1] - These changes are expected to optimize the company's production structure and maintain stable production capacity to meet market demand [1]
康华生物: 关于公司药品生产许可证变更的公告
Zheng Quan Zhi Xing· 2025-07-21 04:18
Core Viewpoint - Chengdu Kanghua Biological Products Co., Ltd. has received an updated "Drug Production License" from the Sichuan Provincial Drug Administration, allowing the company to resume production of the ACYW135 meningococcal polysaccharide vaccine, which meets GMP requirements [1][2]. Group 1: Drug Production License Information - The updated "Drug Production License" is valid until December 9, 2025, and allows the production of preventive biological products, specifically the ACYW135 meningococcal polysaccharide vaccine [1]. - The production facilities include a bacterial vaccine workshop and a packaging workshop located at 182 Beijing Road, Chengdu Economic and Technological Development Zone [2]. Group 2: Impact on the Company - The ACYW135 meningococcal polysaccharide vaccine is used to prevent meningitis caused by serogroups A, C, Y, and W135, and has been exported to 10 countries since its launch [2]. - The approval for the vaccine production facility to meet GMP standards is expected to enhance the company's product structure and better meet market demand, although it is noted that there will be no significant short-term impact on the company's performance [2].