DCGI Gives A Nod To Cipla’s Molnupiravir

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Cipla has been granted an Emergency Use Authorization (EUA) in India to commercialise Cipmolnu (Molnupiravir 200mg), an oral antiviral medicine, for the treatment of adult COVID-19 patients with a SpO2 >93% and a high risk of disease progression, including hospitalisation or death.

The Drug Controller General of India (DCGI) has given Cipla Limited an Emergency Use Authorization (EUA) for the introduction of Molnupiravir in India, the company announced today. Molnupiravir will be marketed by Cipla under the Cipmolnu® brand. Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID-19 infection in persons at high risk of severe disease1.

Cipla and Merck Sharpe Dohme (MSD) agreed on a non-exclusive voluntary licencing agreement to produce and supply Molnupiravir in India and over 100 other low- and middle-income countries earlier this year (LMICs). Regulatory approval came after a five-month collaborative effort by a group of companies.

According to Cipla, Cipmolnu® 200mg capsules will be available soon at all major pharmacies and Covid treatment centres across the country. The company has large manufacturing capacity and a solid distribution mechanism in place to ensure timely availability of this effective drug across India.

“This launch is yet another step in our endeavour to enable access to all treatments in COVID care. We continue to be guided by the power of science to address the unmet needs of patients across the globe and bring care closer to the patients,”

Commenting on the launch, Mr. Umang Vohra (MD and Global CEO, Cipla Limited) said. 

Molnupiravir is an antiviral that stops numerous RNA viruses from replicating, including SARS-CoV-2. Globally, the medication is used to treat non-hospitalized patients with confirmed COVID-19.

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