Hyderabad-based Biophore India Pharmaceuticals has received license from the Drug Controller General of India (DCGI) to manufacture Favipiravir.
Favipiravir is used in the finished formulation to treat mild to moderate cases of COVID-19.
Biophore has received DCGI nod for producing the active pharmaceutical ingredient in India as well as exporting it.
It also received approval in Turkey to export the API in collaboration with a local partner and additionally, the company is in talks with several Indian partners to commercialize the product in India and with Bangladesh and Egypt-based companies for its export, Biophore India said.
“The Covid-19 pandemic has emphasized the need for pharmaceutical companies to step up and develop effective solutions quickly, without compromising on safety.
We have ensured that our favipiravir meets the highest standards of quality,” Founder and Chief Scientific Officer (CSO) of Biophore, Manik Reddy Pullagurla said.
“Our manufacturing facilities comply with US and EU regulations and we have stringent internal impurity controls and quality checks to ensure that.
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,” he said.
Favipiravir is an antiviral agent that was initially discovered and developed because of its activity against another RNA (ribonucleic acid) virus, the influenza virus.
Apart from India and Turkey, it has already been approved for use against COVID-19 in Russia and parts of the Middle East while advanced stage trials are currently underway in other parts of the world.