Sun Pharma’s arm gets EUA to manufacture, market Molxvir in India

Sun Pharmaceutical Industries’ wholly-owned subsidiary has received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of MSD (a trade name of Merck & Co., Inc, Kenilworth, NJ, USA) and Ridgeback’s molnupiravir under the brand name Molxvir in India.

Earlier this year, Sun Pharma had signed a nonexclusive voluntary licensing agreement with MSD to manufacture and supply a generic version of molnupiravir in over 100 low and middle-income countries (LMICs) including India.

The Drugs Controller General of India based on the review of clinical data of molnupiravir has approved molnupiravir for treatment of adult patients with Covid-19, with SpO2 > 93% and who have high risk of progression of the disease including hospitalisation or death.

Molnupiravir has been developed by MSD and Ridgeback Biotherapeutics. It has been approved by the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Emergency Use Authorization. Molxvir is a registered trade mark of Sun Pharma.

Sun Pharma is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.

Source link

Leave a Reply