Biophore India Pharmaceuticals has received Drugs Controller General of India licence to manufacture and export Favipiravir, the active pharmaceutical ingredient (API) of an antiviral drug approved by DCGI for use in the treatment of mild to moderate COVID-19 cases.
Announcing the approval, the Hyderabad-based firm 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 many questions about Favipiravir
Apart from India and Turkey, Favipiravir had been approved for use against Covid-19 in Russia and parts of the Middle East and advanced stage trials were currently underway in other parts of the world.
The company said it was in talks with several Indian partners to commercialise the product in the country and with Bangladesh and Egypt-based companies for its export.
It is also awaiting DCGI approval for a Favipiravir finished dosage form. CEO Jagadeesh Babu Rangisetty said Biophore’s Favipiravir is 100% Made in India.
Drug launched for moderate COVID-19 cases
“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 (CSO) of Biophore Manik Reddy Pullagurla said meeting Favipiravir needs in India is our priority, and 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).
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