Molnupiravir was earlier approved under Emergency Use Authorisation from CDSCO, India. This is the first oral antiviral approved by India, the UK agency and also by US Foods & Drugs Administration. Last week, Japan’s Ministry of Health, Labor and Welfare (MHLW) granted Special Approval for Emergency in Japan for Molnupiravir for infectious disease caused by SARS-CoV-2.   

Earlier last year, Aurobindo had signed a bi-lateral non-exclusive voluntary licensing agreement with Merck Sharpe Dohme, Singapore (MSD), a subsidiary of Merck & Co. (US) to manufacture and supply Molnupiravir to over 100 low and middle-income countries (LMIC), including India.

Mr. K. Nithyananda Reddy, Vice Chairman & Managing Director, Aurobindo said, “We are delighted with the timely permission from DCGI for the licensed version of Molnupiravir (Molnaflu®) as it opens up access to an affordable treatment option for COVID-19 patients and enable us to help battle the pandemic with effective and high-quality pharmaceutical products. We are glad to have partnered with MSD on this product and are committed to enhance access to this product for patients in need, in our partnered territories. The product progresses our mission of being committed to healthier life”.  

For the licensed version of Molnupiravir, Aurobindo enjoys backward integration with in-house API manufacturing which equips it with stronger control on the Quality systems and Supply chain. The product will be manufactured at the Company’s manufacturing facilities in India that are approved by global regulatory agencies including USFDA and UKMHRA. The Company has adequate capacities to meet the global demand across the 100 + LMI Countries for the product.