Ritonavir tablets (100mg) from Geli Pharmaceutical (Zhejiang) Co., LTD was approved for the first time in China on September 9, SDA announced.
The clinical study of this variety was completed by Duzheng Biological "One-stop" (the cooperative co-construction unit, Hunan Occupational Disease Prevention and Control Institute, was responsible for the clinical study, She Tong Smart was responsible for the recruitment, The first lead medicine was responsible for SMO service, weight ke data implementation data management and statistical analysis).
Clinical and analysis of this product are exempt from on-site verification.
Ritonavir, an HIV protease inhibitor developed and produced by Abbott, was first approved by FDA for marketing in the United States in March 1996, and in the European Union in August 1996. Ritonavir officially entered the Chinese market in 2014. This product is clinically effective in the treatment of patients with advanced or non-progressive AIDS, alone or in combination with antiretroviral nucleosides, aligned with dofudine-sensitive and zidovudine-resistant HIV strains with saquinavir.
The company will continue to adhere to the "customer-centric" service concept, to provide domestic partners with clinical research "one-stop" service. From recruitment, clinical, analysis, data, each link seamless, the whole process of information management mode, to ensure that the study of high quality and efficient completion!