First review! Conformity evaluation of cetirizine hydrochloride tablets of Xinhua Pharmaceutical

Today (August 19), Shandong Xinhua Pharmaceutical Co., Ltd announced that its wholly-owned subsidiary Xinhua Pharmaceutical (Gaomi) Co., Ltd recently received the approval document for supplementary drug application of cetirizine hydrochloride 10mg, which was approved and issued by the State Food and drug administration The product passed the consistency evaluation of generic drugs Xinhua Pharmaceutical Co., Ltd has become the first company in China to pass the consistency evaluation of cetirizine hydrochloride tablets (10mg) Cetirizine hydrochloride tablet was first developed and launched by UCB Pharma SA company and sold jointly with various licensees It is a safe and long-term highly selective non sedative histamine H1 receptor antagonist, which is used for the symptomatic treatment of seasonal rhinitis, perennial allergic rhinitis, allergic conjunctivitis, pruritus caused by allergy and urticaria In July 2005, UCB farchimsa of Switzerland obtained the registration certificate of imported drugs in China for the first time, under the trade name of xianteming (Zyrtec ®) At present, the listed enterprises of cetirizine hydrochloride tablets in China include Xinhua Pharmaceutical Co., Ltd., Yangzijiang Pharmaceutical Co., Ltd., Qilu pharmaceutical, etc According to relevant information, the global sales volume of cetirizine hydrochloride in 2018 is about 884 million US dollars As the second generation of H1 receptor antagonists, cetirizine hydrochloride tablets have become the main anti allergic drugs in the domestic market In July 2018, the application materials for conformity evaluation and registration of cetirizine hydrochloride tablets submitted by Xinhua Pharmaceutical Gaomi company to the State Drug Administration were accepted with the acceptance number of cyhb1850119 At present, the varieties of lunanbeite pharmaceutical, Chengdu lile pharmaceutical, Suzhou Dongrui pharmaceutical, Yangzijiang pharmaceutical and Suzhou Sinochem are under review and approval As of July 31, 2019, the R & D investment for the consistency evaluation project of cetirizine hydrochloride tablets is about 8 million yuan.