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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
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性依法承担法律责任。 近日,湖南华纳大药厂股份有限公司(以下简称"公司")全资子公司湖南华纳大药厂手性药物有限公司 (以下简称"手性药物")收到国家药品监督管理局签发的盐酸异丙肾上腺素、重酒石酸去甲肾上腺素 《化学原料药上市申请批准通知书》(通知书编号:2025YS00924、2025YS00925),并在国家药品监 督管理局药品审评中心(CDE)"原辅包登记信息"平台公示。具体情况如下: 一、原料药登记信息 (一)盐酸异丙肾上腺素 1、化学原料药名称:盐酸异丙肾上腺素 2、登记号:Y20240000173 3、申请事项:境内生产化学原料药上市申请 8、与制剂共同审评审批结果:A (二)重酒石酸去甲肾上腺素 1、化学原料药名称:重酒石酸去甲肾上腺素 2、登记号:Y20240000250 3、申请事项:境内生产化学原料药上市申请 4、包装规格:100g/桶。200g/桶。500g/桶。1kg/桶。2kg/桶。3kg/桶。 5、生产企业:湖南华纳大药厂手性药物有限公司 4、包装规格:0.1kg/桶、0 ...
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
华纳药厂公告,全资子公司湖南华纳大药厂手性药物有限公司收到国家药品监督管理局签发的盐酸异丙 肾上腺素、重酒石酸去甲肾上腺素《化学原料药上市申请批准通知书》。盐酸异丙肾上腺素用于治疗心 源性或感染性休克等,重酒石酸去甲肾上腺素用于控制急性低血压状态下的血压。这将丰富公司产品 线,提升核心竞争力。 ...
华仁药业:全资子公司盐酸异丙肾上腺素原料药获得上市申请批准通知书
Zheng Quan Ri Bao Wang· 2025-09-02 13:16
Group 1 - The core point of the article is that Huaren Pharmaceutical announced the approval of its subsidiary Anhui Hengxing Pharmaceutical's application for "Isoproterenol Hydrochloride" as a chemical raw material drug by the National Medical Products Administration [1] Group 2 - The approval signifies a significant milestone for the company, potentially enhancing its product portfolio and market competitiveness [1]
华仁药业(300110.SZ):安徽恒星制药的盐酸异丙肾上腺素原料药获得上市申请批准通知书
Ge Long Hui A P P· 2025-09-02 08:33
Core Viewpoint - Huaren Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Isoproterenol Hydrochloride, indicating a significant advancement in its product portfolio and potential market opportunities [1] Group 1: Company Developments - Huaren Pharmaceutical's wholly-owned subsidiary, Anhui Hengxing Pharmaceutical Co., Ltd., has been granted the approval for Isoproterenol Hydrochloride, a non-selective β-adrenergic agonist [1] - The approval notification number for the marketing application is 2025YS00767, highlighting the regulatory progress made by the company [1] Group 2: Product Information - Isoproterenol Hydrochloride is known for its strong positive inotropic and chronotropic effects, as well as its bronchodilator properties, making it clinically relevant for treating conditions such as cardiogenic or septic shock, complete atrioventricular block, cardiac arrest, and acute bronchial asthma attacks [1]
华仁药业:盐酸异丙肾上腺素原料药获得上市申请批准通知书
Mei Ri Jing Ji Xin Wen· 2025-09-02 08:33
Core Viewpoint - Huanren Pharmaceutical's wholly-owned subsidiary, Anhui Hengxing Pharmaceutical, has received approval from the National Medical Products Administration for the production and sale of "Isoproterenol Hydrochloride" in the domestic market [1] Group 1 - The approval includes the issuance of a "Chemical Raw Material Drug Listing Application Approval Notice" [1] - The raw material drug has met the relevant technical standards for raw material drug review in the country [1] - This development allows the company to expand its product offerings in the domestic market [1]
华仁药业:子公司盐酸异丙肾上腺素原料药获上市批准
Xin Lang Cai Jing· 2025-09-02 08:33
Core Viewpoint - Hainan Pharmaceutical's subsidiary, Anhui Hengxing Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of "Isoproterenol Hydrochloride" [1] Company Summary - The approval of Isoproterenol Hydrochloride, a non-selective β-adrenergic agonist, will enhance the company's active pharmaceutical ingredient (API) product line [1] - This product is primarily used for treating cardiogenic or infectious shock, complete atrioventricular block, cardiac arrest, and acute bronchial asthma attacks [1] - The addition of this product is expected to improve the company's market competitiveness [1]
华仁药业:盐酸异丙肾上腺素原料药获批上市
Core Viewpoint - Huanren Pharmaceutical's subsidiary, Anhui Hengxing Pharmaceutical, has received approval from the National Medical Products Administration for the marketing application of "Isoproterenol Hydrochloride" [1] Group 1: Company Developments - The approval pertains to Isoproterenol Hydrochloride, a non-selective β-adrenergic agonist that strongly stimulates both β1 and β2 receptors [1] - Isoproterenol Hydrochloride is clinically used for treating conditions such as cardiogenic or infectious shock, complete atrioventricular block, cardiac arrest, and acute bronchial asthma attacks [1]
华仁药业(300110.SZ):盐酸异丙肾上腺素化学原料药上市申请获批准
智通财经网· 2025-09-02 08:22
Core Viewpoint - Huaren Pharmaceutical's subsidiary, Anhui Hengxing Pharmaceutical, has received approval from the National Medical Products Administration for the marketing application of Isoproterenol Hydrochloride, a non-selective β-adrenergic agonist used in various clinical treatments [1] Group 1 - The approved drug, Isoproterenol Hydrochloride, is known for its strong positive inotropic and chronotropic effects, as well as its bronchodilator properties [1] - Clinical applications of Isoproterenol Hydrochloride include treatment for cardiogenic or septic shock, complete atrioventricular block, cardiac arrest, and acute bronchial asthma attacks [1]