Cetirizine hydrochloride tablet of Xinhua Pharmaceutical is the first to pass the consistency evaluation of generic drugs

On the evening of August 18, Xinhua Pharmaceutical released an enterprise announcement that its wholly-owned subsidiary, Xinhua Pharmaceutical (Gaomi) Co., Ltd ("Gaomi company of Xinhua Pharmaceutical"), recently received the supplementary application approval of cetirizine hydrochloride tablets of 10mg specification approved and issued by the State Drug Administration, which passed the consistency evaluation of quality and efficacy of generic drugs Xinhua Pharmaceutical Co., Ltd has become the first company in China to pass the consistency evaluation of cetirizine hydrochloride tablets (10mg) According to the announcement, on July 16, 2018, the application materials for conformity evaluation and registration of generic drugs of the product submitted by Xinhua Pharmaceutical Gaomi company to the State Drug Administration were accepted The product is used for seasonal rhinitis, perennial allergic rhinitis, allergic conjunctivitis and allergic pruritus and urticaria Cetirizine hydrochloride tablet was first developed and launched by ucbpharmasa company and sold jointly with various licensees It is a safe and long-term highly selective non sedative histamine H1 receptor antagonist In July 2005, UCB farchimsa, a Swiss company, obtained the registration certificate of imported drugs in China for the first time, with the trade name of xianteming ® (Zyrtec ®) At present, the listed companies 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, this product has become the main anti allergy drug popular in China As of July 31, 2019, the R & D investment for the consistency evaluation project of cetirizine hydrochloride tablets is about 8 million yuan The product has a good anti allergic effect and a broad clinical application prospect According to the pharmaceutical intelligence data, up to now, Xinhua Pharmaceutical has applied for a total of 11 varieties of conformity evaluation, which have been approved by glimepiride tablets and evaluated by cetirizine hydrochloride tablets, so as to improve the quality of the company's generic drugs and increase the competitive strength of its products.