Hyderabad, April 27 :  Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs, on Tuesday announced 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 the treatment of Covid-19.
Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other Low-and Middle-Income Countries (LMICs), following the approvals for emergency use and authorization by local regulatory agencies, the pharmaceutical company said in a release here.
Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase 3 trial for the treatment of non-hospitalized patients with confirmed Covid-19.
MSD is developing Molnupiravir in collaboration with Ridgeback Biotherapeutics.
Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: “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.
We will be immediately approaching the DCGI to seek regulatory pathway and emergency use authorization. We remain committed to the global fight against the pandemic and will continue to provide access to potential therapies for Covid-19 treatment,” he said.
Molnupiravir will be manufactured in our world-class formulation facility in Hyderabad, which has been approved by stringent global regulatory authorities such as USFDA and EU, among others.
Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide and approved by stringent global regulatory authorities.
It is one of the largest manufacturers of generic Remdesivir globally and its brand ‘Covifor’ (Remdesivir) has been supplied to more than 2 million patients globally.(UNI)