Molnupiravir was earlier approved under Emergency Use Authorisation from the Central Drugs Standard Control Organisation.
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.
K Nithyananda Reddy, Vice Chairman and 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”.
For the licensed version of Molnupiravir, Aurobindo enjoys backward integration with in-house API (active pharmaceutical ingredient) manufacturing which equips it with stronger control on the Quality systems and Supply chain.
The product will be made at the Company’s manufacturing facilities in India that are approved by global regulatory agencies including USFDA and UK MHRA.
The company has adequate capacities to meet the global demand across the over 100 LMI Countries for the product, Aurobindo said.