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Tag: Biophore

health

Biophore receives sub-license from MPP to manufacture and market molnupiravir for COVID treatment

Jan 21, 2022 by Gouri 0 Comments #Biophore, #Biophore India Pharmaceuticals, #Jagadeesh Babu Rangisetty, #Molnupiravir, #MPP

Hyderabad, 20 January 2022: Biophore India Pharmaceuticals has announced that it has received a license from Medicines Patent Pool (MPP) on behalf of originator company MSD, a trading 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 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 the 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 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. Similarly, we are committed to bringing molnupiravir to the market in the shortest time possible complying with all quality and regulatory requirements – all our products are manufactured in US FDA approved facilities.”

business, health

Biophore to manufacture indigenous ingredients of Pfizer’s COVID drug

Jan 19, 2022 by Gouri 0 Comments #Biophore, #Biophore India PharmaceuticalsJagadeesh Babu Rangisetty, #Pfizer’s COVID drug, #Rameswara Rao Chandana

Hyderabad, January 19, 2022: Biophore India Pharmaceuticals has today announced that they have developed and started manufacturing the key intermediates of Nirmatrelvir, one of the active ingredients of Paxlovid, the latest anti-COVID therapy, approved by the US FDA through the emergency use authorisation route. The manufacturing is being done in collaboration with Rakshit Group. This is expected to greatly reduce the dependence on imports, mainly from China, from where these intermediates are being procured currently. Biophore is also manufacturing Nirmatrelvir in a US FDA compliant facility and has announced that they will be filing for approval with DCGI soon.

Paxlovid’s breakthrough approval was given by the US FDA in Dec 2021 and is indicated for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients as well and in those who are at high risk of progression to severe levels. It was the first oral pill that has been approved by US FDA and with a better safety profile than subsequently approved oral therapies. It is available in a co-pack of Nirmatrelvir and Ritonavir Tablets.

Dr. Jagadeesh Babu Rangisetty, CEO at Biophore, says, “The development and manufacturing of these intermediates are extremely complex and is significantly more challenging than earlier antivirals that have been indicated for COVID. We have developed the intermediates that are required for the manufacturing of this product from basic raw materials and have the manufacturing capabilities in place to produce high volumes, to the scale of multi tons, catering to Indian as well as global markets. As and when the product gets approved in India, we can ensure that the manufacturers of this product can be self-reliant from within India itself and not be dependent on imports, which can be tricky in terms of control of quality and supply”

 Mr. Rameswara Rao Chandana, Chairman of Rakshit Group, says, “Rakshit Group’s subsidiary, Sainor Laboratories, is the largest manufacturer of Lithium HMDS in India with a capacity of 500 MT per month and has the facilities to handle cryogenic reactions. Manufacturing of these intermediates require extreme temperatures and large volumes of Lithium reagents and with the above infrastructure that we have, we are well placed to ensure that the requirements for the market can be met locally. With a strong partner such as Biophore, we believe this is a perfect synergy to get these products to the market quickly”