· Can market in India and 104 other countries
· Has also received DCGI regulatory license for Indian market
· Licenses applicable for both API and finished product
Biophore India Pharmaceuticals has announced that it has received license from Medicines Patent Pool (MPP) on behalf of originator company MSD, a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, to manufacture and market molnupiravir API and finished product in capsules form. The company said that the development of the product is complete and is gearing up for launch based on this license within the next one week. The license received by Biophore enables the company to launch the product within India as well as export to 104 other countries around the world.
For the Indian market, the company has informed that it has already received the relevant regulatory approvals from DCGI and will be launching the product next week at one of the lowest prices currently in the market – Rs 1500 for a pack of 40 Capsules.
Molnupiravir is an oral antiviral approved through the emergency use authorization route by the US Food and Drug Administration and UK authorities for treatment of mild to moderate COVID-19. Its effectiveness has been established through studies conducted across the world and is expected to significantly reduce hospitalization of COVID-19 patients, if taken at an early stage. In India too, DCGI has approved this product for the treatment of COVID-19 based on the review of clinical data available.
Dr. Jagadeesh Babu Rangisetty, CEO at Biophore, says, “Biophore has been at the forefront of the fight against COVID-19 and we are extremely proud of this fact. During the earlier wave, we had successfully scaled up and commercialized Favipiravir, the antiviral approved during that time for COVID-19 treatment, in record time. We are also the largest Indian manufacturers of SBECD, a vital ingredient for Remdesivir injection manufacturing and have also developed Nirmatrelvir, which is the active ingredient in the other US FDA approved oral COVID-19 antiviral. Similarly, we are committed to bring molnupiravir to the market in the shortest time possible complying to all quality and regulatory requirements – all our products are manufactured in US FDA approved facilities.”
Views: 0
