August 25, the State Food and Drug Administration announced that Chengdu Hengrui Pharmaceutical Co., LTD. Cetirizine hydrochloride tablets (10mg) successfully approved!
The clinical study of this variety was completed by Duzheng Biology "One-stop" (changsha Central Hospital, a cooperative co-construction unit, was responsible for the clinical study, Serong Intelligence was responsible for recruitment, Leading Medicine was responsible for SMO service, weights and data management and statistical analysis). The verification, clinical and analytical tests were exempted.
On May 29, 2020, chengdu Hengrui Pharmaceutical Co., Ltd. submitted the registration application data of citirizine hydrochloride tablets (10mg) for generic drug consistency evaluation to the State Medical Products Administration (SDA), which was accepted. The product has a good anti-allergic effect, mainly used for seasonal rhinitis, perennial allergic rhinitis, allergic conjunctivitis and allergy caused by pruritus and urticaria symptomatic treatment. Cetirizine hydrochloride tablets, originally developed and marketed by UCBPharma SA in association with various license-holders, are a safe, long-acting, highly selective unsedated histamine H1 receptor antagonist. In July 2005, UCBFarchimSA obtained the import drug registration certificate in China for the first time, with the product name Zyrtec.
At present, there are 7 listed cetirizine hydrochloride tablets in China, including Xinhua Pharmaceutical Gaomi Co., LTD., Yangzijiang Pharmaceutical Co., LTD., Chengdu Hengrui Pharmaceutical Co., LTD. According to relevant information, global sales in 2018 were about 884 million US dollars. As a second-generation H1 receptor antagonist, the product has a bright prospect in the domestic OTC market.
Duzheng Biotech is committed to providing high-quality, professional and efficient "one-stop" service for pharmaceutical and medical device clinical research for global biomedical enterprises. To help enterprises seize the priority market and become a trustworthy strategic partner of China's pharmaceutical industry.