Cipla launches remdesivir under brand name CIPREMI

22 Jun 2020 Evaluate

Cipla has launched remdesivir under its brand name CIPREMI. The USFDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients. It is the only USFDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection. In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla's generic version of remedisvir called CIPREMI.

The company has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need. As part of a risk management plan, the company will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.

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