Aurobindo Pharma gets DCGI nod for Molnupiravir generic version
Aurobindo Pharma has secured consent from the Drugs Controller General of India (DCGI) for manufacturing and distributing its generic version of Covid drug Molnupiravir under the brand name — Molnaflu.
The Indian pharma company had previously acquired the licensing rights for the generic version of MSD and Ridgeback Biotherapeutics’ Molnupiravir.
A non-exclusive voluntary licensing agreement was signed by Aurobindo Pharma with Merck Sharpe Dohme, Singapore (MSD), a subsidiary of Merck & Co. (US) for manufacturing and supplying Molnupiravir to more than 100 low and middle-income countries (LMIC), including India.
Molnupiravir is an oral antiviral, which has been approved by the UK Medicines and Healthcare products Regulatory Agency (UKMHRA) for treating mild-to-moderate Covid-19 in adults.
The drug has also been approved by the US Food and Drug Administration (FDA) and under Emergency Use Authorization (EUA). Recently, Japan’s Ministry of Health, Labor and Welfare (MHLW) had given Special Approval for Emergency in Japan for Molnupiravir for infectious disease resulting from SARS-CoV-2.
K. Nithyananda Reddy — Vice Chairman of Aurobindo Pharma 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 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”.