Biophore receives sub-license to manufacture Molnupiravir

Hyderabad, Jan 20:  Biophore India Pharmaceuticals on Thursday announced that it has received license from Medicines Patent Pool (MPP) on behalf of originator company MSD, a trade name of Merck to manufacture and market Molnupiravir API and finished product in capsule form.

The Hyderabad-based company said that the development of the product is complete and is gearing up for launch based on this licence within the next one week. The licence received by Biophore enables the company to launch the product within India as well as export to 104 other countries around the world, the company said in a statement.

For the Indian market, the company has already received the relevant regulatory approvals from Drug Controller General of India (DCGI) and will be launching the product next week at one of the lowest prices currently in the market - Rs 1,500 for a pack of 40 capsules.

Molnupiravir is an oral antiviral approved through the emergency use authorisation 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 hospitalisation of Covid-19 patients, if taken at an early stage. In India too, the DCGI has approved this product for the treatment of Covid-19 based on the review of clinical data available.

"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 commercialised Favipiravir, the antiviral approved during that time for Covid 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 antiviral," said CEO Dr Jagadeesh Babu Rangisetty.

"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," he added.