Cipla announced the launch of remdesivir under its brand name CIPREMI. Remdesivir is US FDA approved Emergency Use Authorisation (EUA) treatment for adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19 infection. In May, Gilead Sciences extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remdesivir called CIPREMI. Cipla received regulatory approval by the Drug Controller General of India (DCGI) very recently for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need. They also stated that, as part of a risk management plan, Cipla will provide training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance as well as to conduct a Phase IV clinical trial on Indian patients. The drug will be supplied through Government and open market channels, to ensure equitable distribution.
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