Aurobindo gets DCGI's nod to manufacture & market its generic version of Molnupiravir to be marketed as Molnaflu

Aurobindo Pharma Limited on Tuesday said that it along with its subsidiaries together referred to as Aurobindo has received the Drugs Controller General of India's (DCGI's) 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, to be marketed as Molnaflu.

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 low and middle-income countries (LMIC), including India.

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).

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.

Mr. K. Nithyananda Reddy, Vice Chairman, Aurobindo said, "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 COVID19 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 a healthier life".

For the generic version of Molnupiravir, Aurobindo 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.

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 for the treatment of adult COVID-19 patients in India, subject to certain conditions.