Hetero, one of India's leading generic pharmaceutical companies and the world's largest producer of anti-retroviral drugs, announced on 27 April that it has entered into a non-exclusive voluntary licensing agreement with MSD for the manufacturing and distribution of investigational oral therapeutic antiviral drug Molnupiravir for treatment of COVID-19.

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Under this licensing deal, Hetero will be allowed to expand access to Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorisation by local regulatory agencies. Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase 3 trial for the treatment of non-hospitalised patients with confirmed COVID-19. MSD is developing Molnupiravir in collaboration with Ridgeback Biotherapeutics. "Hetero has partnered with MSD to enable access of Molnupiravir for COVID-19 to the Indian population at this much important time to fight the pandemic. We are vertically integrated to manufacture and commercially ready to supply this product to patients swiftly across the country," said Dr B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies.

"We will be immediately approaching the DCGI to seek regulatory pathway and emergency use authorisation. We remain committed to the global fight against the pandemic and will continue to provide access to potential therapies for COVID-19 treatment", he added. Molnupiravir will be manufactured in Hetero's world-class formulation facility in Hyderabad, which has been approved by stringent global regulatory authorities such as USFDA and EU, among others.