药品生产许可变更
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重庆华森制药股份有限公司关于公司药品生产许可证变更的公告
Shang Hai Zheng Quan Bao· 2025-11-18 19:01
Core Viewpoint - Chongqing Huason Pharmaceutical Co., Ltd. has received a change in its drug production license, extending the contract manufacturing period for Montelukast Sodium Granules until March 2, 2026, which is expected to enhance the company's production capacity utilization [1][3]. Group 1: License Change Details - The change involves the extension of the contract manufacturing period for Montelukast Sodium Granules, a product commissioned by Youhua Pharmaceutical Technology Co., Ltd. [1]. - The new drug production license number is 渝20150018, issued by the Chongqing Drug Administration [1]. Group 2: Product Information - Montelukast Sodium Granules are indicated for the prevention and long-term treatment of asthma in children over one year old, as well as for alleviating symptoms of allergic rhinitis in children aged 2 to 5 [2]. - The product is classified as a national medical insurance category B product and is recommended in several authoritative clinical guidelines, highlighting its significant market presence and advantages in pediatric formulations [2]. Group 3: Market Performance - The overall market for Montelukast Sodium has reached maturity, but the granule formulation for children continues to show strong growth potential [2]. - In the past five years (2020-2024), the cumulative sales of Montelukast Sodium formulations in domestic hospital terminals have reached 5.545 billion yuan [2]. Group 4: Impact on the Company - The change in the drug production license is expected to improve the company's production capacity utilization, although it will not have a significant short-term impact on the company's performance [3].
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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-14 08:54
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].