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葵花药业集团股份有限公司关于盐酸非索非那定口服混悬液获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2025-09-01 20:05
Group 1 - The company has received the drug registration certificate for Desloratadine Oral Suspension from the National Medical Products Administration, indicating compliance with drug registration requirements [1][4] - The drug is indicated for the relief of symptoms associated with seasonal allergic rhinitis in children aged 2 and above, and chronic idiopathic urticaria in children aged 6 months and above [2][3] - The product is classified as a prescription drug and falls under the category of Class 3 chemical drugs, with a specification of 120ml containing 0.72g of the active ingredient Desloratadine [6][4] Group 2 - The approval of Desloratadine Oral Suspension will help the company expand its product pipeline and enhance its therapeutic area coverage [4] - The company plans to strengthen quality and process control during the product's subsequent mass production and market launch [4] - The drug registration number for Desloratadine is H20255183, and the manufacturing entity is Chongqing Little Sunflower Children's Pharmaceutical Co., Ltd., a subsidiary of the company [6][4]