New Delhi, Dec 28 (PTI) Aurobindo Pharma on Tuesday said it will produce generic version of the antiviral drug Molnupiravir at its domestic manufacturing facilities which have been approved by global agencies like the USFDA and UKMHRA.
Molnupiravir is used in the treatment of COVID-19.
The Hyderabad-based drug maker said it would sell the product under the brand ‘Molnaflu’ and has adequate capacities to meet the global demand across the 100 plus Low and Middle-Income Countries (LMIC), Aurobindo Pharma said in a regulatory filing.
The drug maker said it has received the DCGI’s (Drugs Controller General of India) permission to manufacture and distribute its in-licensed generic version of MSD (a trade name of Merck & Co., Inc, Kenilworth, NJ, USA) and Ridgeback’s Molnupiravir.
Earlier this year, Aurobindo had signed a 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 LMICs, including India.
“We are delighted with the timely permission from DCGI for the generic version of Molnupiravir 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,” Aurobindo Pharma Vice Chairman K Nithyananda Reddy stated.
For the generic version of Molnupiravir, the company said it enjoys backward integration with in-house API manufacturing which equips it with stronger control on supply chain and cost efficiencies.
“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 plus LMIC for the product,” it noted.
The DCGI, based on the review of clinical data of Molnupiravir, has given permission to manufacture and market anti COVID-19 pill Molnupiravir for restricted emergency use in India for treatment of adult patients, subject to certain conditions.
Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (UKMHRA) for the treatment of mild-to-moderate COVID-19 in adults.
It has also been recently approved by the US Food and Drug Administration (USFDA) and under Emergency Use Authorisation (EUA). PTI MSS RUJ RUJ
