药品注册
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山东新华制药股份子公司获得非那雄胺片《药品注册证书》
Zhi Tong Cai Jing· 2025-08-05 08:56
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Finasteride tablets, which will enhance its product portfolio and open new market opportunities [1] Group 1 - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Finasteride tablets from the National Medical Products Administration [1] - The registration certificate for Finasteride tablets was granted in August 2025, indicating a future product launch [1] - This development is expected to contribute positively to the company's growth by diversifying its product offerings [1]
昂利康:西格列汀二甲双胍缓释片获得药品注册证书
Xin Lang Cai Jing· 2025-07-31 09:57
7月31日,昂利康公告,公司获得国家药品监督管理局核准签发的西格列汀二甲双胍缓释片《药品注册 证书》。西格列汀二甲双胍缓释片为复方制剂,适用于正在接受西格列汀和二甲双胍缓释片联合治疗的 成人2型糖尿病患者。公司于2024年1月获得西格列汀二甲双胍缓释片药品上市许可申请受理通知书,并 于近日获得国家药监局批准。根据国家相关政策规定,本次获得《药品注册证书》视同通过一致性评 价。 ...
一品红子公司获得复方聚乙二醇电解质散(Ⅲ)注册证书
Zhi Tong Cai Jing· 2025-07-31 04:03
此次公司获得复方聚乙二醇电解质散(Ⅲ)注册证书,标志着公司具备了在国内市场销售该规格药品的资 格,将进一步丰富公司产品管线和产品品类,增强了公司的核心竞争力。 一品红(300723)(300723.SZ)发布公告,公司全资子公司广州一品红制药有限公司于近日收到国家药 品监督管理局核准签发的关于复方聚乙二醇电解质散(Ⅲ)的《药品注册证书》,复方聚乙二醇电解质散 (Ⅲ)适应症为:用于以下情况之前的患者结肠清洁准备:--内窥镜或放射检查--结肠手术,本品适用于成 人。 ...
昂利康:获得美索巴莫注射液药品注册证书
news flash· 2025-07-30 11:06
Core Viewpoint - The company, Anglikang (002940), has received a drug registration certificate from the National Medical Products Administration for Mesobam Injection, which is intended for the treatment of acute skeletal muscle pain or discomfort [1] Group 1: Product Information - Mesobam Injection is classified as a Class 3 chemical drug with a specification of 10ml:1g [1] - The approval of the drug registration certificate will enhance the company's product pipeline [1] Group 2: Market Considerations - The sales performance of Mesobam Injection may be influenced by national policies and changes in the market environment, indicating a significant level of uncertainty [1]
华北制药股份有限公司关于公司获得《药品注册证书》的公告
Shang Hai Zheng Quan Bao· 2025-07-29 17:34
Core Viewpoint - North China Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) from the National Medical Products Administration, indicating the product's compliance with quality and efficacy standards for generic drugs [1][2]. Group 1: Drug Registration Details - The Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) was approved on July 29, 2025, after being submitted for review in April 2024 [2][4]. - Adenosylcobalamin is primarily used for the prevention and treatment of Vitamin B12 deficiency and related conditions, such as megaloblastic anemia [2][5]. Group 2: Research and Development - The company has invested a total of 10.9382 million yuan in research and development for this product [3]. - The product is expected to be produced and marketed following the receipt of the registration certificate [4]. Group 3: Market Situation - A total of 27 companies, including North China Pharmaceutical, hold the Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) in China [5]. - The sales volume for the capsule form is projected to be approximately 29,000 units in 2024, with total sales across all forms expected to reach around 1.5 billion units, reflecting a 19% increase from 2023 [5]. Group 4: Impact on the Company - The approval of the Drug Registration Certificate enhances the company's product pipeline in hematology and hematopoietic system medications, meeting the basic requirements for centralized procurement bidding [6].
华北制药(600812.SH):腺苷钴胺胶囊(0.5mg)获得药品注册证书
智通财经网· 2025-07-29 09:04
华北制药(600812.SH)发布公告,近日,公司收到国家药品监督管理局核准签发的腺苷钴胺胶囊(0.5mg) 的《药品注册证书》。 本品可抑制神经髓鞘异常脂肪合成,阻断神经纤维脱髓鞘的发生和发展;促进蛋白质、类脂合成,修复 受损神经;降低异常TNFα水平,抑制SACD发生、参与三羧酸循环,促进三大物质代谢,维护细胞正常 功能;使谷光甘肽含量正常化,保护神经细胞;参与血红素合成,改善贫血。腺苷钴胺主要用于维生素 B12缺乏症的防治,维生素B12需求量增加而从饮食中摄取不足时的补充(消耗性疾病、甲亢、孕妇、哺 乳期妇女等),巨幼红细胞性贫血等。 ...
福元医药:联苯苄唑溶液获得药品注册证书
Xin Lang Cai Jing· 2025-07-29 08:31
Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) announced that its wholly-owned subsidiary, Fuyuan Pharmaceutical Co., has received the Drug Registration Certificate for Lufenuron Solution from the National Medical Products Administration, allowing the production of this medication for treating skin fungal diseases, including tinea, candidiasis, and vitiligo [1] Group 1 - The approval for Lufenuron Solution was granted following the acceptance notification received on January 12, 2024, indicating a successful application process [1] - The acquisition of the Drug Registration Certificate is considered equivalent to passing the consistency evaluation as per national policy regulations [1] - According to data from Minet, the sales revenue for Lufenuron Solution in China's three major terminal markets is approximately 375 million yuan in 2024 [1]
济川药业:子公司获得复方聚乙二醇(3350)电解质散药品注册证书
news flash· 2025-07-11 08:23
Group 1 - The core point of the article is that Jichuan Pharmaceutical's subsidiary has received a drug registration certificate for Compound Polyethylene Glycol (3350) Electrolyte Powder, which is intended for the treatment of chronic constipation and fecal impaction [1] - The product is chocolate-flavored and is one of the five companies in China that have passed the consistency evaluation for this drug [1] - According to data from Minai Network, the sales revenue for Compound Polyethylene Glycol Electrolyte in urban public hospitals and retail pharmacies in China is projected to be 838 million yuan and 8 million yuan respectively in 2024 [1] Group 2 - The approval of the drug registration certificate is expected to have a positive impact on the company's future development [1] - However, the market development cycle for the drug's launch may take time and is subject to uncertainties influenced by pharmaceutical industry policies and procurement bidding [1]
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]