expresspharmaJune 22, 2020
Tag: cipla , CIPREMI , Remdesivir
Cipla announced the launch of remdesivir under its brand name CIPREMI. Remdesivir is US FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalised 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. “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 conduct a Phase IV clinical trial on Indian patients”, informed the company through a statement.
The statement also informed that 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.
Commenting on the launch, Umang Vohra, MD and Global CEO, Cipla said, “Cipla appreciates the strong partnership with Gilead to bring remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by COVID-19 pandemic, and this launch is a significant milestone in that direction. We will continue to collaborate with all stakeholders in the healthcare ecosystem towards providing access to such promising treatments in furtherance with our belief that no patient should be denied access to life-saving treatments.”
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