Cipla Limited announced on Tuesday, 28 December, that it has been granted Emergency Use Authorization (EUA) permission by the Drug Controller General of India (DCGI) for the launch of Molnupiravir, an anti-viral drug to treat mild to moderate COVID-19.
Cipla plans to launch Molnupiravir under the brand name Cipmolnu. 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 at high risk of developing severe disease.
Earlier this year, Cipla entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir in India and to over 100 low and middle-income countries (LMICs).
The regulatory approval comes on the back of a five-month collaborative trial conducted by a consortium of companies.
Cipla will soon make Cipmolnu 200mg capsules, which will be available at all leading pharmacies and COVID treatment centres across the country.
The company has adequate manufacturing capacities and a solid distribution mechanism in place to ensure speedy access to this effective treatment pan India.
Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. The drug is used for the treatment of non-hospitalised patients with COVID-19 globally.
Commenting on the launch, Umang Vohra (MD and Global CEO, Cipla Limited) said it was "yet another step in our endeavour to enable access to all treatments in COVID care".