Biophore India gets DCGI nod to manufacture COVID drug Favipiravir API

Biophore India Pharmaceuticals, a Hyderabad-based firm, has received license from the Drug Controller General of India (DCGI) to manufacture Favipiravir, an active pharmaceutical ingredient (API), used in the finished formulation to treat mild to moderate COVID-19 cases. Besides DCGI’s nod to produce the drug in India, it has been cleared for exports as well.

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.

CEO of Biophore, Jagadeesh Babu Rangisetty said all starting materials and complex intermediates for making favipiravir are either sourced locally or have been developed in-house for use. “We are confident that this API will help our country move several steps forward in our united fight against Covid- 19,”Jagadeesh Babu said. Biophore is also awaiting DCGI approval for a favipiravir finished dosage form.