Workflow
药品注册获批
icon
Search documents
葵花药业集团股份有限公司 关于复方聚乙二醇(3350)电解质口服溶液获得药品注册证书的公告
Group 1 - The company has received the drug registration certificate for Compound Polyethylene Glycol (3350) Electrolyte Oral Solution from the National Medical Products Administration [1][4] - The drug is approved for the treatment of chronic constipation and fecal impaction [3] - The product will enhance the company's "One Elderly" strategy, expanding its product matrix in the elderly care sector [4][2] Group 2 - The drug is classified as a Class 3 chemical drug and is a prescription medication [7] - The main components of the drug include Polyethylene Glycol 3350, Sodium Chloride, Potassium Chloride, and Sodium Bicarbonate [7] - The company plans to initiate mass production and market launch of the new product, leveraging its brand and marketing network [4][2]
复星医药:重酒石酸去甲肾上腺素注射液药品注册申请获批
Zhi Tong Cai Jing· 2026-01-22 11:52
Core Viewpoint - Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, has received approval from the National Medical Products Administration for the registration of a drug, norepinephrine injection, which is indicated for the treatment of acute hypotension and as an auxiliary treatment for cardiac arrest [1] Group 1 - The approved drug is indicated for restoring blood pressure in acute hypotensive states [1] - It can also be used as an auxiliary treatment for cardiac arrest and maintaining blood pressure after resuscitation [1] - The drug serves as an auxiliary treatment for shock due to hypovolemia, helping to temporarily maintain cerebral and coronary perfusion until volume resuscitation takes effect [1]
复星医药(600196.SH):膦甲酸钠注射液获注册批准
智通财经网· 2025-12-10 08:58
Core Viewpoint - Fosun Pharma's subsidiary, Guilin Pharmaceutical Co., has received approval from the National Medical Products Administration for the registration of sodium phosphonate injection, which is indicated for the treatment of cytomegalovirus retinitis in AIDS patients and herpes simplex virus infections in immunocompromised patients [1] Group 1 - The approved drug is sodium phosphonate injection [1] - The indications for the drug include treatment for cytomegalovirus retinitis in AIDS patients [1] - The drug is also indicated for herpes simplex virus infections in patients with immune dysfunction [1]
康弘药业:米拉贝隆缓释片获药品注册证书
Zhi Tong Cai Jing· 2025-11-24 12:31
Core Viewpoint - Kanghong Pharmaceutical has received the drug registration certificate for Mirabegron extended-release tablets from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product [1] Company Summary - Kanghong Pharmaceutical (002773.SZ) has announced the approval of Mirabegron, a selective β3 adrenergic receptor agonist, which acts on bladder tissue to relax bladder smooth muscle [1]
葵花药业(002737.SZ):复方聚乙二醇(3350)电解质散取得药品注册证书
智通财经网· 2025-11-14 08:04
Core Viewpoint - The company has received the drug registration certificate for Compound Polyethylene Glycol (3350) Electrolyte Powder from the National Medical Products Administration, which will enable it to accelerate the mass production and market launch of the new product [1] Group 1 - The company plans to expand its product matrix and optimize its product structure layout following the approval [1] - The company aims to leverage its brand resource advantages to enhance market competitiveness [1]
苑东生物:艾拉莫德片获药品注册证书
Xin Lang Cai Jing· 2025-10-17 08:39
Core Insights - The company announced that its wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., received the drug registration certificate for Elamomab tablets from the National Medical Products Administration [1] - Elamomab tablets are indicated for the treatment of active rheumatoid arthritis and are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1] - The projected sales amount for Elamomab tablets in key public hospitals in major provinces and cities for 2024 is approximately 382 million yuan, representing a year-on-year growth of 12.90% [1] - The approval of this drug is considered equivalent to passing the consistency evaluation, and it is not expected to have a significant impact on the company's recent performance [1]
石四药集团:苯磺酸左氨氯地平片获药品生产注册批件
Zhi Tong Cai Jing· 2025-10-17 04:13
Core Viewpoint - The company has obtained the drug production registration approval from the National Medical Products Administration of China for Amlodipine Besylate Tablets (5mg and 2.5mg), classified as a Category 4 chemical drug, indicating it has passed the consistency evaluation [1] Group 1 - Amlodipine Besylate Tablets are primarily used for the treatment of hypertension, chronic stable angina, and vasospastic angina, and can be used alone or in combination with other medications [1]
成都苑东生物制药股份有限公司关于自愿披露盐酸乙哌立松片获得药品注册证书的公告
Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. has received the drug registration certificate for its product, Hydrochloride Ephedrine Tablets, marking a significant milestone in its product portfolio and compliance with regulatory standards [1][2]. Drug Basic Information - Drug Name: Hydrochloride Ephedrine Tablets - Dosage Form: Tablets - Specification: 50mg - Registration Category: Class 4 Chemical Drug - Validity Period: 18 months - Holder of Marketing Authorization: Chengdu Shuo De Pharmaceutical Co., Ltd. - Production Company: Chengdu Shuo De Pharmaceutical Co., Ltd. - Drug Registration Standard Number: YBH23792025 - Approval Conclusion: The product meets the requirements for drug registration and has been granted a registration certificate [1][2]. Drug Indications - Hydrochloride Ephedrine Tablets are indicated for: 1. Improving muscle tension in conditions such as cervical shoulder-arm syndrome, periarthritis of the shoulder, and low back pain 2. Spastic paralysis caused by cerebrovascular disorders, spastic myelopathy, cervical spondylosis, postoperative sequelae, traumatic sequelae, amyotrophic lateral sclerosis, infantile cerebral palsy, and other spinal cord diseases [2]. Market Performance - The sales amount for Hydrochloride Ephedrine Tablets in public hospitals in key provinces and cities is projected to be approximately 102.61 million yuan in 2024, reflecting a year-on-year growth of 14.01% [3]. Impact on the Company - The approval of Hydrochloride Ephedrine Tablets signifies that the product meets the necessary registration requirements and is considered to have passed the consistency evaluation. However, it is noted that the approval will not have a significant impact on the company's short-term performance [4].
山东新华制药股份收到熊去氧胆酸胶囊《药品注册证书》
Zhi Tong Cai Jing· 2025-09-16 08:56
Core Viewpoint - Shandong Xinhua Pharmaceutical's subsidiary, Shandong Zibo Xinda Pharmaceutical, has received approval for Ursodeoxycholic Acid Capsules from the National Medical Products Administration, enhancing the company's product offerings in the digestive system medication sector [1] Group 1: Regulatory Approval - The company submitted the application for Ursodeoxycholic Acid Capsules to the Center for Drug Evaluation in January 2024, which was accepted [1] - The product received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1] Group 2: Product Indications - Ursodeoxycholic Acid Capsules are indicated for the treatment of cholesterol gallstones, cholestatic liver diseases, and bile reflux gastritis [1] Group 3: Market Potential - The product is classified as a Category A drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1] - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately RMB 2.155 billion in 2024 [1] Group 4: Strategic Impact - The approval of Ursodeoxycholic Acid Capsules is expected to enrich the company's product variety in digestive system medications and enhance its overall competitiveness [1]
一品红(300723.SZ):全资子公司获得草酸艾司西酞普兰滴剂注册证书
Ge Long Hui A P P· 2025-08-25 10:54
Core Viewpoint - The company Yipinhong (300723.SZ) has received approval from the National Medical Products Administration for its drug, Escitalopram Oxalate Drops, which is indicated for the treatment of depression and panic disorder with or without agoraphobia [1] Group 1: Product Approval - Yipinhong's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has recently obtained the drug registration certificate for Escitalopram Oxalate Drops [1] - The approved indication for the drug includes treatment for depression and panic disorder, with or without agoraphobia [1] Group 2: Mechanism of Action - Escitalopram is the S-enantiomer of racemic citalopram, and its antidepressant effect is believed to be related to the inhibition of serotonin (5-HT) reuptake in the central nervous system, thereby enhancing serotonergic activity [1] Group 3: Market Potential - The drug was registered as a Class 3 chemical drug, which is considered equivalent to passing the consistency evaluation [1] - According to data from Minet, the sales scale of Escitalopram in urban and county-level public hospitals in China is projected to be approximately 1,879.76 million RMB in 2024 [1]