Hyderabad: Aurobindo Pharma Limited, an integrated global pharmaceutical company headquartered in Hyderabad, on Thursday announced it has launched its brand Molnupiravir – ‘Molnaflu’-, an oral Covid drug for the treatment of adult patients, who have a high risk of progression of the disease including hospitalization or death.
Molnaflu is now available pan-India across all major metros and towns through our distribution partner, the pharmaceutical company said in a release here.
Molnupiravir was earlier approved under Emergency Use Authorisation from Central Drugs Standard Control Organisation(CDSCO).
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 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.
Aurobindo Vice-Chairman and Managing Director K. Nithyananda Reddy said, We are delighted with the timely permission from Drugs Controller General of India (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.
We are glad to have partnered with MSD on this product and are committed to enhancing access to this product for patients in need, in our partnered territories. The product progresses our mission of being committed to a healthier life, he added.
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 + LMI Countries for the product.
The company has 27 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.