Dr. Reddy’s Laboratories receives DCGI approval to launch Molnupiravir capsules 200mg (Molflu™) in India
Hyderabad: Dr. Reddy’s Laboratories today announced that it 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 the treatment of adult patients with COVID-19, with SpO2 >93% and who have high risk of progression of the disease 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).
Dr. Reddy’s will soon launch its molnupiravir capsules 200mg under the brand name Molflu™ across India. As a vertically integrated company, Dr. Reddy’s is able to manufacture the active pharmaceutical ingredient (API) as well as the formulation for molnupiravir, and has made adequate capacity preparations to ensure that it is able to help patients in India as well as in patient populations in need around the world.
“Molnupiravir is a continuation of our constant effort since the start of the pandemic to ensure access to every possible treatment option against COVID-19 from prevention to mild, moderate and severe disease for patients in India and around the world. 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. Throughout the pandemic, we have sought to create diverse collaborations and partnerships to meet unmet medical needs of as many patients as possible globally.”– G.V. Prasad, Co-Chairman and Managing Director, Dr. Reddy’s
Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. It has been studied by Merck & Co., Inc., in collaboration with Ridgeback Biotherapeutics in a Phase III trial for the treatment of non-hospitalized patients with confirmed COVID-19 globally. It has received approvals from regulatory authorities in the U.K., U.S and Japan.