Biophore obtains a nod from DCGI to manufacture and export Favipiravir


Hyderabad: Biophore India Pharmaceuticals, a city-based company, has received a license from the Drug Controller General of India (DCGI) to manufacture Favipiravir, an active pharmaceutical ingredient (API), used in the final formulation to treat cases of mild COVID-19 to moderate.

Besides the head sign of DCGI to produce the drug in India, it has also been licensed for export.

It has also received approval in Turkey to export the API in collaboration with a local partner and, in addition, the company is in talks with several Indian partners to market the product in India and with Bangladesh and

Companies based in Egypt for export, said Biophore India.

"The Covid-19 pandemic has underscored the need for pharmaceutical companies to scale up and rapidly develop effective solutions without compromising safety. We have ensured that our favipiravir meets the highest quality standards", said the founder and chief scientific director (CSO) of Biophore, said Manik Reddy Pullagurla.

"Our manufacturing facilities comply with US and European regulations and we have internal impurity controls and rigorous quality controls to guarantee this. Meeting the needs of favipiravir in India is our priority, and we have the capacity to "Increase production to meet local requirements, without compromising our exports," he said.

Favipiravir is an antiviral agent that was originally discovered and developed because of its activity against another RNA (ribonucleic acid) virus, the influenza virus.

Outside of India and Turkey, it has already been approved for use against COVID-19 in Russia and parts of the Middle East while advanced trials are currently underway in others. parts of the world.

Biophore CEO Jagadeesh Babu Rangisetty said that all of the starting materials and complex intermediates for making favipiravir either come from locally or have been developed in-house for use.

"We are confident that this API will help our country take several steps forward in our united fight against Covid-19," said Jagadeesh Babu.

Biophore is also awaiting DCGI approval for a finished dosage form of favipiravir.

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