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湖南华纳大药厂股份有限公司 自愿披露关于子公司原料药获得上市申请批准通知书的公告
Core Points - The company has received approval from the National Medical Products Administration for the production of two chemical raw materials: Isoproterenol Hydrochloride and Dexamethasone Tartrate [1][2][3] - The approval indicates that these raw materials meet the national drug review technical standards and will enhance the company's product line and core competitiveness [5] Raw Material Registration Information - **Isoproterenol Hydrochloride**: - Registration Number: Y20240000173 - Application: Domestic production of chemical raw materials - Packaging Specifications: 0.1kg, 0.2kg, 0.5kg, 1kg, 2kg, 3kg, 5kg [1] - Production Company: Hunan Warner Pharmaceutical Chiral Drugs Co., Ltd. - Production Address: Changsha City, Hunan Province [1] - Approval Conclusion: Complies with drug registration requirements [1][4] - **Dexamethasone Tartrate**: - Registration Number: Y20240000250 - Application: Domestic production of chemical raw materials - Packaging Specifications: 100g, 200g, 500g, 1kg, 2kg, 3kg [2] - Production Company: Hunan Warner Pharmaceutical Chiral Drugs Co., Ltd. - Production Address: Changsha City, Hunan Province [2] - Approval Conclusion: Complies with drug registration requirements [2][4] Drug Information - **Isoproterenol Hydrochloride**: Used for treating cardiogenic or infectious shock and complete atrioventricular block, cardiac arrest [4] - **Dexamethasone Tartrate**: Used for blood pressure control in acute hypotensive states and as an adjunct in cardiac arrest and severe hypotension [5]
华纳药厂再获两款急救药原料药批件,年内累计已达8个
Core Insights - Warner Pharmaceutical's subsidiary has received approval for two chemical raw materials, indicating compliance with national drug review standards and enhancing the company's product line and core competitiveness [1][2] Group 1: Regulatory Approvals - Warner Pharmaceutical's subsidiary, Hunan Warner Pharmaceutical, received approval for isoproterenol hydrochloride and racemic norepinephrine raw materials, marking the 7th and 8th raw material approvals in 2023 [1] - The company now has a total of 72 raw material varieties, with 55 approved for use in formulations [1] Group 2: Product Applications - Isoproterenol hydrochloride is used in injection form for treating cardiogenic or infectious shock and complete atrioventricular block [1] - Racemic norepinephrine is utilized for blood pressure control in acute hypotensive states and as an adjunct treatment for cardiac arrest and severe hypotension [1] Group 3: Market Relevance - Both isoproterenol hydrochloride and racemic norepinephrine injections are common emergency medications and are included in the "clinically essential and easily short-supplied drugs" list [1] - Racemic norepinephrine injection has been included in the 10th batch of national centralized procurement [1]
华纳药厂:子公司原料药获得上市申请批准通知书
Zheng Quan Ri Bao· 2025-10-23 13:37
Group 1 - Warner Pharmaceuticals announced that its wholly-owned subsidiary, Hunan Warner Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of Isoproterenol Hydrochloride and Dextroamphetamine Tartrate [2] - The approval notification has been published on the Drug Evaluation Center (CDE) platform of the National Medical Products Administration [2]
华纳药厂:子公司原料药获上市申请批准通知书
Xin Lang Cai Jing· 2025-10-23 09:08
Core Insights - Warner Pharmaceuticals announced that its wholly-owned subsidiary, Hunan Warner Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the marketing application of Isoproterenol Hydrochloride and Levonordefrin Tartrate [1] Product Development - Isoproterenol Hydrochloride is indicated for the treatment of cardiogenic or infectious shock, while Levonordefrin Tartrate is used to manage blood pressure in acute hypotensive states [1] Competitive Advantage - The approval will enrich the company's product line and enhance its core competitiveness in the pharmaceutical market [1]