Biophore India Pharmaceuticals has received Drugs Controller General of India’s licence to manufacture and export Favipiravir, the active pharmaceutical ingredient (API) of an antiviral drug approved by the DCGI for use in the treatment of mild to moderate COVID-19 cases.
Announcing the approval, the Hyderabad-based firm on Tuesday said it has successfully completed validation of Favipiravir and scaled-up its production.
Biophore said it has also received approval in Turkey in collaboration with a local Turkish partner.
The company said it was in talks to commercialise the product in India and with Bangladesh and Egypt-based companies for its export. It is also awaiting the DCGI’s approval for a Favipiravir finished dosage form.
CEO Jagadeesh Babu Rangisetty said the company’s Favipiravir is 100% made in India. “We are not dependent on any imports to produce Favipiravir. All starting materials and complex intermediates are either sourced locally or have been developed in-house for use,” he said.
Founder and Chief Scientific Officer Manik Reddy Pullagurla said “meeting Favipiravir needs in India is our priority. We have the capacity to scale up production to meet local requirements, without compromising on our export commitments.”
Favipiravir is also the name of the generic version of Fujifilm Toyama Chemical Co’s Avigan, a product indicated for treatment of novel influenza virus infections and whose clinical trials on COVID-19 patients were initiated in China, Japan and in the U.S. following the pandemic. In India, Glenmark has completed the phase three clinical trial with Favipiravir (Fabiflu).