药品注册
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莱美药业:阿奇霉素颗粒获药品注册证书
news flash· 2025-06-24 08:04
Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Azithromycin granules, which is a macrolide antibiotic used for infections caused by sensitive bacteria [1] Group 1: Company Developments - The approval of Azithromycin granules will help to further enrich the company's product line [1] - A total of 41 companies have obtained the registration certificate for this drug [1] Group 2: Market Insights - According to data from Yaorongyun, the sales revenue of Azithromycin granules in the Chinese hospital market was 120 million yuan, 127 million yuan, and 95 million yuan for the years 2022, 2023, and the first half of 2024, respectively [1]
多瑞医药:注射用头孢唑肟钠获药品注册证书
news flash· 2025-06-13 08:58
Core Viewpoint - Duorui Pharmaceutical (301075) has received approval from the National Medical Products Administration for the injection of Cefoperazone Sodium, indicating a significant development in its product portfolio [1] Company Summary - Duorui Pharmaceutical's wholly-owned subsidiary, Hubei Duorui Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Cefoperazone Sodium injection, with specifications of 0.5g/1.0g [1] - The drug registration certificate is valid until June 9, 2030, with certificate numbers 2025S01726/2025S01727 and approval numbers H20254471/H20254472 [1] Industry Summary - Sales data from 2022 to 2024 for Cefoperazone Sodium injection shows revenue figures of 4.139 billion, 4.144 billion, and 3.078 billion respectively, indicating a slight decline in projected sales for 2024 [1]
联环药业: 联环药业关于公司获得《药品注册证书》的公告
Zheng Quan Zhi Xing· 2025-06-04 09:18
Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for its product, Dopamine Hydrochloride Injection, which is expected to enhance the company's product line and market competitiveness [1][2]. Group 1: Drug Registration Details - The Drug Registration Certificate pertains to Dopamine Hydrochloride Injection, classified as a Class 3 chemical drug and a prescription medication [1][2]. - The product specifications include a dosage form of injection with a concentration of 100 mg in a 5 ml vial [1]. - The approval number for the registration is CYHS2303423, and the certificate number is 2025S01492 [1]. Group 2: Market Context and Financial Impact - The Dopamine Hydrochloride Injection is used for treating heart failure due to decreased myocardial contractility in organic heart disease, with a reported sales figure of 444 million RMB in 2024 [2]. - The company has invested approximately 7 million RMB in research and development for this product as of the announcement date [2]. - The acquisition of the Drug Registration Certificate is not expected to have a significant impact on the company's recent operating performance [2]. Group 3: Company Development - The company has obtained a total of 7 production licenses and 1 clinical license in 2025 [2]. - The approval of the Drug Registration Certificate signifies that the product has passed the consistency evaluation of generic drug quality and efficacy [2].
华纳药厂:硫酸沙丁胺醇注射液获药品注册证书
news flash· 2025-04-23 09:08
Core Viewpoint - Warner Pharmaceuticals has received approval from the National Medical Products Administration for the registration certificate of Salbutamol Sulfate Injection, which is intended for the treatment of bronchial asthma and wheezing bronchitis associated with bronchospasm [1] Group 1 - The drug is classified as a Category 3 chemical drug under the new registration classification, indicating it has passed the consistency evaluation [1] - The acquisition of this registration certificate enriches the company's formulation product variety, positively impacting the optimization of the company's product structure [1]
立方制药:取得马来酸噻吗洛尔滴眼液药品注册证书
news flash· 2025-04-22 10:06
立方制药(003020)公告,近日收到国家药品监督管理局核准签发的马来酸噻吗洛尔滴眼液《药品注册 证书》。该药品为眼科降眼压用药,适用于治疗眼内高压症以及青光眼。公司本次取得药品注册证书的 马来酸噻吗洛尔滴眼液为化学药品注册分类3类,质量和疗效与参比制剂一致。药品的生产和销售可能 受到政策和市场等因素影响,仍具有一定的不确定性。 ...
东北制药:孙公司获得左卡尼汀口服溶液药品注册证书
news flash· 2025-04-16 11:24
Core Viewpoint - Northeast Pharmaceutical (000597) announced that its wholly-owned subsidiary, Shenyang Shide Pharmaceutical Co., Ltd., received the Drug Registration Certificate from the National Medical Products Administration for L-Carnitine Oral Solution, which is approved for treating primary systemic carnitine deficiency and secondary carnitine deficiency due to congenital metabolic disorders [1] Group 1 - The drug L-Carnitine Oral Solution has the approval number H20253799 and is valid until March 31, 2030 [1] - The approval of L-Carnitine Oral Solution is expected to enrich the company's product pipeline [1] - This development enhances the company's market competitiveness and presents new market opportunities [1]
华纳药厂:重酒石酸间羟胺注射液获药品注册证书
news flash· 2025-04-15 09:55
Group 1 - The company has received the drug registration certificate for heavy tartrate hydroxylamine injection from the National Medical Products Administration [1] - The drug is indicated for the prevention and treatment of acute hypotension during epidural anesthesia and other conditions [1] - The registration of this drug enhances the company's product variety and positively impacts the optimization of its product structure [1]
同和药业:获得韩国药品注册证书
news flash· 2025-04-15 08:40
同和药业(300636)公告,公司近日收到韩国食品药品安全部颁发的美阿沙坦钾药品注册证书。生产商 名称为江西同和药业股份有限公司,生产商地址为江西省奉新高新技术产业园区,认证范围为美阿沙坦 钾原料药,证书编号为2025-A1-0844,签发日期为2025.04.14。美阿沙坦钾适用于治疗成人原发性高血 压。公司美阿沙坦钾产品获得韩国药品注册证书,标志着公司美阿沙坦钾原料药获得了韩国市场的准入 资格,将对公司进一步扩大国际市场业务起到积极作用。 ...
哈药股份:中药二厂乳果糖口服溶液获药品注册证书
news flash· 2025-04-10 07:35
Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. has received approval from the National Medical Products Administration for the registration of Lactulose Oral Solution, which is used for the treatment and prevention of chronic or habitual constipation and hepatic encephalopathy [1] Company Summary - The Lactulose Oral Solution has a total of 60 domestic drug approval numbers and 5 import drug approval numbers as of the announcement date [1] - The annual sales revenue of Lactulose Oral Solution in China for 2023 is 1.769 billion yuan [1]
东北制药:子公司获得左乙拉西坦缓释片药品注册证书
news flash· 2025-04-09 08:46
Core Viewpoint - Northeast Pharmaceutical (000597) announced that its subsidiary, Shenyang First Pharmaceutical Co., Ltd., received the drug registration certificate from the National Medical Products Administration for Levetiracetam Extended-Release Tablets, which is approved for use in patients aged 12 and above for adjunctive treatment of partial seizures in epilepsy [1] Summary by Category - **Product Approval** - The drug name is Levetiracetam Extended-Release Tablets, with the approval number Guoyao Zhunzi H20253711, valid until March 24, 2030 [1] - The medication is specifically indicated for patients aged 12 years and older who experience partial seizures as part of their epilepsy treatment [1]