Hyderabad-based Aurobindo Pharma has made its brand of molnupiravir- Molnaflu available widely in India. The drug is for treatment of adult patients with Covid-19, with Sp02 >93 per cent and who have high risk of progression of the disease including hospitalisation or death.

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 the 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 Sharp 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 & managing director, Aurobindo said, the timely permission from DCGI for the licensed version of molnupiravir opens up access to an affordable treatment option for Covid-19 patients.

For the licensed version of molnupiravir, Aurobindo has backward integration with in-house bulk drug 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 that are approved by global regulatory agencies including the USFDA and UK MHRA. The company has adequate capacities to meet the global demand across over 100 low-and middle-income countries for the product.

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