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Ascletis Pharma has submitted the marketing authorization application for ritonavir (100 mg film-coated tablet) in the Hong Kong Special Administrative Region of the People's Republic of China.
Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) released on March 15, 2022 by the National Health Commission of the People's Republic of China includes PF-07321332/ritonavir (Paxlovid) as an antiviral therapy. Recently, Ascletis has further expanded its ritonavir oral tablet production capacity to approximately 530 million tablets per year, to meet the potential escalation in the domestic and global demand.
Ascletis aims to be a global commercial supplier of ritonavir oral tablets. To date, Ascletis owns the only authorized ritonavir oral tablet in China, which has passed bioequivalence study. Ascletis' ritonavir oral tablet was approved in September 2021 by China National Medical Products Administration. Ascletis has submitted marketing authorization applications for ritonavir (100 mg film-coated tablet) in 12 European countries (Germany, France, Ireland, the United Kingdom, Spain, Portugal, Italy, Belgium, Poland, Sweden, the Netherlands and Denmark) through its agent in Europe.
