DCGI grants Cipla emergency use authorisation for COVID-19 drug Molnupiravir
Dec 28, 2021
Mumbai (Maharashtra) [India], December 28 : Drug Controller General of India (DCGI) on Tuesday granted Emergency Use Authorisation (EUA) to Cipla for the launch of Molnupiravir in the country for COVID-19 treatment.
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.
MD and Global CEO of Cipla, Umang Vohra, said, "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."
Earlier in the 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 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 antiviral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. The drug is used for the treatment of non-hospitalized patients with confirmed COVID-19 globally.