Indian drug company gets DCGI nod to manufacture Covid-19 medicine
Favipiravir is an antiviral agent that was initially discovered and developed because of its activity against another RNA
A pharmaceuticals firm based in India, Biophore India Pharmaceuticals has received a license from the Drug Controller General of India (DCGI) to manufacture Favipiravir. The active pharmaceutical salt is an important part of the finished formulation to treat mild to moderate Covid-19 cases.
Favipiravir is an antiviral agent that was initially discovered and developed because of its activity against another RNA (ribonucleic acid) virus, the influenza virus.
The drug has also received acceptance in Russia and parts of middle east in order to fight against Covid-19. Other than these regions, it is also in advanced stage trials in other parts of the world.
The new drug also received approval for exports as well. The drug has been cleared in Turkey to export the API with the help of a local partner. Biophore India Pharmaceuticals is also in talks with several Indian partners in order to commercialize the product in India and with Bangladesh and Egypt-based companies for its export.
"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.
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.
With Inputs from PTI
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