Biophore ramps upMade-In-India Favipiravir productionfor Covid-19!
Receives approval in Turkey
Has manufacturing capacity to meet all local and global commitments
Chennai, July 14, 2020: Hyderabad-based Biophore India Pharmaceuticals has announced that it has successfully completed the validation of favipiravir and scaled-up its production. Favipiravir is theactive pharmaceutical ingredient (API) that can beused in the finished formulationof an antiviral drugapproved 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 alsoreceived approval in Turkey in collaboration with a local Turkish partner. Additionally, the company is in talks with several Indian partners to commercializethe 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, says, “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 regulationsand we have stringent internal impurity controls and quality checks to ensure that. Meeting favipiravir needs inIndia 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.[i]Apart from India and Turkey, it has already been approved for use against Covid-19 in Russia[ii] and parts of the Middle East[iii] and advanced stage trials are currently underway in other parts of the world.
Dr. Jagadeesh Babu Rangisetty, CEO at Biophore, says, “In line with Prime Minister Narendra Modi’s call to Make in India, and become vocal for local[iv], 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.
About Biophore India Pharmaceuticals:
Founded in 2007, Biophore India Pharmaceuticals is an established pharmaceutical company that develops and manufactures niche pharmaceutical products for the generic industry. Biophore’s state-of-the-art, multipurpose manufacturing facilities in Visakhapatnam comply with cGMP standards and meet the requirements of US and EU Drug regulatory authorities. Its technology development center in Hyderabad is equipped with infrastructure that facilitates the entire process of drug research from conceptualization to regulatory submissions. Biophore’s portfolio is spread across 30 therapeutic segments and specializes in development and manufacturing of pharmaceutical actives for Oncology medication, Contrast and Diagnostic media. To date, the company has filed about more than 100 drug master files and 150 patents for its unique portfolio.
