药品注册获批
Search documents
苑东生物: 苑东生物:关于自愿披露奥沙西泮片获得药品注册证书的公告
Zheng Quan Zhi Xing· 2025-06-04 12:24
Group 1 - The company has received the drug registration certificate for Oxazepam Tablets from the National Medical Products Administration, indicating compliance with drug registration requirements [1][2] - Oxazepam Tablets are classified as a Class 3 chemical drug with a specification of 15mg and a shelf life of 18 months [1][2] - The drug is primarily used for short-term relief of anxiety, tension, and agitation, and can also assist in treating anxiety with depression and acute alcohol withdrawal symptoms [2] Group 2 - The product was originally developed by Wyeth and later acquired by Pfizer, with the first launch in Sweden in 1966 under the brand name Sobril [2] - In 2024, the sales amount for Oxazepam Tablets in key public hospitals in China exceeded 500 million yuan, with the product's sales amounting to approximately 10.044 million yuan, reflecting a year-on-year growth of 9.58% [2] - The company has signed a cooperation agreement with Jiangsu Enhua and Xin Medical Marketing Co., Ltd., where the company will be responsible for production and supply, while Jiangsu Enhua will handle exclusive commercialization in mainland China [3]
国药现代:子公司盐酸咪达普利片注册证书获批
news flash· 2025-06-04 09:10
Core Viewpoint - The company Guoyao Modern (600420) has received approval from the National Medical Products Administration for the registration of its product, Lisinopril Tablets, which is indicated for the treatment of primary hypertension and secondary hypertension due to renal parenchymal disease [1] Summary by Relevant Categories Product Approval - Guoyao Modern's wholly-owned subsidiary, Guoyao Rongseng, has obtained the drug registration certificate for Lisinopril Tablets, enhancing the company's competitiveness in the cardiovascular medication market [1] Market Potential - According to the Minet database, the projected sales for Lisinopril Tablets in public medical institutions across the country for 2024 is estimated at RMB 25.45 million [1] R&D Investment - The cumulative research and development investment for this project by Guoyao Rongseng amounts to approximately RMB 7.717 million [1] Financial Impact - The approval of the drug registration certificate is not expected to have a significant impact on the company's current operating performance [1]
亿帆医药股份有限公司关于获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2025-04-08 23:26
Core Viewpoint - Yifan Pharmaceutical has received the drug registration certificate for Hydrochloride Etizolam Injection, marking its entry into the controlled substance market and enhancing its product portfolio [1][4]. Group 1: Drug Registration Information - The drug name is Hydrochloride Etizolam Injection, classified as a chemical drug of category 3 [2][3]. - The approval conclusion states that the product meets the requirements for drug registration according to Chinese regulations [1][2]. - The drug registration certificate was issued on April 8, 2025, with a validity period until March 31, 2030 [3]. Group 2: Product Overview - Hydrochloride Etizolam Injection is indicated for pain relief, particularly for cancer pain and postoperative pain [2]. - The company submitted the drug application in June 2023, received acceptance in July 2023, and obtained the research approval for controlled substances in September 2023 [2]. - The product is the first of its kind in China to pass the consistency evaluation for generic drugs [2]. Group 3: Market and Financial Impact - The domestic sales of Hydrochloride Etizolam Injection reached 128 million yuan in 2023 [2]. - The company has invested approximately 10.02 million yuan in the research and development of this product [2]. - The approval of this product is expected to positively impact the company's performance and enhance its competitiveness in the pharmaceutical sector [4].
亚宝药业: 亚宝药业集团股份有限公司关于取得药品注册证书的公告
Zheng Quan Zhi Xing· 2025-03-24 08:20
Core Viewpoint - Company has received the drug registration certificate for Isopropylphenazone injection from the National Medical Products Administration, enhancing its product portfolio and market competitiveness [1][2]. Group 1: Drug Registration Certificate - The drug registration certificate for Isopropylphenazone injection was approved and issued by the National Medical Products Administration, with certificate number 2025S00738 [1]. - The product is indicated for acute spasmodic pain caused by digestive system and biliary dysfunction, acute spasmodic urethral, bladder, and renal colic, as well as gynecological spasmodic pain [1]. Group 2: Market and Sales Data - The Isopropylphenazone injection was developed by Laboratoire L.lafon and was approved for sale in France in 1993, with Teva Sante as the current license holder under the brand name Spasfon® [1]. - According to data from Minet, the sales amount of Isopropylphenazone injection in China for 2023 is approximately 1.387 billion RMB [1]. Group 3: Competitive Landscape - As of the announcement date, there are three other companies in China that have obtained registration approval for Isopropylphenazone injection [2]. - The acquisition of the registration certificate is expected to improve the company's product competitiveness in the market [2].
人福医药: 人福医药关于多巴丝肼片获得药品注册证书的公告
Zheng Quan Zhi Xing· 2025-03-24 08:20
Core Viewpoint - The announcement highlights that Renfu Pharmaceutical has received the drug registration certificate for its product, Dopamine Hydrazine Tablets, which allows the company to produce and sell the drug in the domestic market, thereby enriching its product line and potentially generating positive impacts on its business [1][3]. Group 1: Drug Registration Details - The drug name is Dopamine Hydrazine Tablets, which is indicated for the treatment of Parkinson's disease and symptomatic Parkinson's syndrome, excluding drug-induced Parkinson's syndrome [2]. - The registration approval was granted by the National Medical Products Administration, confirming that the product meets the necessary requirements for drug registration [2]. - The cumulative R&D investment for this project is approximately RMB 15 million [2]. Group 2: Market and Sales Potential - The estimated national sales for Dopamine Hydrazine Tablets in 2023 is around RMB 890 million, with the main competitor being Roche Pharmaceuticals [2]. - The company plans to arrange for the production and market launch of the drug based on market demand [3]. - The product's future sales may be influenced by industry policies and market conditions, indicating some level of uncertainty [3]. Group 3: Regulatory and Production Information - The drug is classified as a Class 4 chemical drug, with a shelf life of 24 months [3]. - The drug registration number is H20253650, and the approval is valid until March 17, 2030 [3]. - The production will be handled by Yichang Renfu Pharmaceutical Co., Ltd., a subsidiary of the company [3].