Everest Organics starts API production for Merck anti-COVID pill

Manufacturer starts development of API for molnupiravir, which is set to become world’s first oral treatment against coronavirus

India’s Everest Organics has started manufacturing the active pharmaceutical ingredient for Merck & Co’s investigational antiviral pill, molnupiravir, to treat mild to moderate COVID-19, the API manufacturer said in a filing to the Bombay Stock Exchange.

“After the successful development and commercialization of various COVID-19 drugs, such as Oseltamivir, Remdesivir, Posaconazole, Everest Organics is on its path of expansion of this portfolio and hence has further developed an additional COVID-19 treatment API in that segment,” said Srikakarlapudi Sirisha, Chief Executive Officer, New Product Development at Everest Organics.

The company said in the filing that the drug was being developed at lab scale.

Earlier this month, Merck and partner Ridgeback Biotherapeutics announced that in a Phase 3 trial, molnupiravir reduced the risk of hospitalization and death by around 50% for patients with mild or moderate cases of COVID-19. The APl is administered orally and works by inhibiting the replication of the coronavirus inside the body.

The two companies have submitted an Emergency Use Application for the pill to the US Food and Drug Administration, which if approved would make it the world’s first oral antiviral treatment for COVID-19.

Everest Organics has an API facility in Hyderabad, India and manufactures and exports APIs to more than 40 countries as well as serving domestic demand.