Hyderabad-based Biophore India Pharmaceuticals has announced that it has successfully completed the validation of favipiravir and scaled-up its production. Favipiravir is the active pharmaceutical ingredient (API) that can be used in the finished formulation of an antiviral drug approved by the Drug Controller General of India (DCGI) for mild to moderate cases of Covid-19.
Biophore has received the DCGI license to manufacture the API in India and has been cleared for export as well. It has also received approval in Turkey in collaboration with a local Turkish partner. 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.
Dr. Manik Reddy Pullagurla, Founder and Chief Scientific Officer (CSO) of Biophore, 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. 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 of favipiravir to meet local requirements, without compromising on our export commitments.”
Favipiravir is an antiviral agent that was initially discovered and developed because of its activity against another RNA 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 and advanced stage trials are currently underway in other parts of the world.
Dr. Jagadeesh Babu Rangisetty, CEO at Biophore, said, “In line with Prime Minister Narendra Modi’s call to Make in India, and become vocal for local, I am proud to say that Biophore’s favipiravir is 100% Made in India. This is what sets us apart from many other suppliers of this API. 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. We are confident that this API will help our country move several steps forward in our united fight against Covid-19.”
Biophore is also awaiting DCGI approval for a favipiravir finished dosage form.