Kaneka Corporation, Tokyo, will manufacture and supply intermediates to Shionogi & Co., in Osaka, for use in Xocova®*1 (Ensitrelvir Fumaric Acid) Tablets 125mg), a drug for the treatment of SARS-Cov-2 infection.
On November 22, Shionogi received emergency regulatory approval from Japan’s Ministry of Health, Labour and Welfare to manufacture and sell Xocova® tablets for treating SARS-Cov-2 infection. Shionogi recognized Kaneka for its long years of experience in manufacturing raw materials for medicines, and selected Kaneka as its main supplier for the drug's intermediates, which require GMP*2 management. The two companies have worked closely together for clinical development, approval application, and establishment of mass production supply chain. Kaneka will continue to improve its manufacturing systems and provide Shionogi with a stable supply of intermediates, playing a vital role in Shionogi's commercial supply chain.
Kaneka will continue to address a broad range of infection-related issues for COVID-19 and other diseases through initiatives including contract manufacturing of drug substance of DNA vaccine, development of antibody drugs, supplying PCR testing reagents and testing kits, and vaccine transportation using isothermal shipping packages.