Pharma major Dr Reddy’s Laboratories Ltd. has received emergency-use authorisation from the Drugs Controller General of India (DCGI) to manufacture and market the oral anti-viral drug Molnupiravir capsules 200mg for treatment of adult patients with Covid-19.
The drug has been authorised to be used for Covid-19 patients who have high risk of disease progression including hospitalisation or death.
Earlier this year, Dr. Reddy’s entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs).
In a first-of-its-kind collaboration in the Indian pharmaceutical industry, a Dr. Reddy’s-led consortium of pharma companies collaborated to jointly sponsor, supervise and monitor the phase III clinical trial in India, and presented its findings to the Subject Expert Committee (SEC).
Hyderabad-based Dr Reddy’s will soon launch its Molnupiravir capsules 200mg under the brand name Molflu across India.
“The approval to launch Molnupiravir is an important development not only as a treatment option, but also for the collaborative manner in which Indian pharma companies came together,” GV Prasad, Co-Chairman and Managing Director, Dr Reddy’s, said in a release.