Cipla has launched Cipremi (remdesivir lyophilised powder for injection 100 mg), the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for patients with severe COVID-19 disease.
The announcement was made on Sunday, 21 June 2020. Shares of Cipla fell 0.69% to end at Rs 637.10 on Friday.
Cipla on Sunday announced the launch of remdesivir under its brand name CIPREMI. The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized coronavirus disease (COVID-19) patients. It is the only U.S. FDA 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.
Cipla 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, Cipla 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.
As part of its efforts to enable speedy and equitable access to this treatment and in anticipation of demand, Cipla will be commercialising remdesivir through its own facilities and partnered sites. The drug will be supplied through Government and open market channels, to ensure equitable distribution.
Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics. Its strengths are in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments.
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