Emcure Pharmaceuticals Ltd (EPL) said it has received an Emergency Use Authorisation (EUA) approval from the Drug Controller General of India for the introduction of Molnupiravir, an investigational oral anti-viral drug, for the treatment of mild COVID-19.
EPL plans to roll out the drug under the brand name Lizuvira in the Indian market.
“As the need for such a drug is imminent in the face of emerging challenges in COVID-19 treatment, EPL will endeavour to deliver Lizuvira (Molnupiravir) in a week’s time. A toll-free Helpline will be dedicated to help the doctors and patients access the product,” the company said in a statement.
Earlier this year, EPL had entered into a licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs).
It is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2, according to the company.
The drug, being developed by MSD and Ridgeback Biotherapeutics has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and U.S. Food and Drug Administration (US FDA) for the treatment of mild-to-moderate COVID-19 at high risk of developing severe disease, the company said.
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