Biophore India Pharma arm gets CDSCO nod to manufacture, sell generic version of Pfizer COVID drug Paxlovid
It was the first oral pill that has been approved by USFDA and with a better safety profile than subsequently approved oral therapies.
Advertisement
Hyderabad: Hyderabad-based Zenara Pharma, a fully owned subsidiary of Biophore India Pharmaceuticals, has announced that it has received approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell Nirmatrelvir and Ritonavir tablets in a combi pack as a treatment option for patients with mild to moderate symptoms of Covid-19.
The tablet, which will be sold under the brand name 'Paxzen', is being manufactured at Zenara's USFDA approved state-of-the- art facility in Hyderabad.
This approval by the CDSCO has been granted under the emergency authorization route considering the unmet medical need in COVID-19 for an effective and affordable therapy for the patients Dr. Jagadeesh Babu Rangisetty, Co-founder and Managing Director at Zenara Pharma, says, "We believe Paxzen is an extremely effective treatment option against COVID-19 and, at the same time, is a verycomplex product to develop and manufacture. We have brought this product to the market in record time and this is one of the first approvals of this product in India. I am proud to say that we have our own in-house API and are not dependent on any imports for the production. We believe that this will ensure stability and rapid production and availability of this treatment for the Indian market."
This product's breakthrough approval in the US was given by the US FDA in Dec 2021 and is indicated for the treatment of mild-to-moderate COVID-19 in adults. It was the first oral pill that has been approved by USFDA and with a better safety profile than subsequently approved oral therapies.
Dr Srinivas Arutla, CEO, Zenara Pharma, says, "We expect to launch Paxzen in the next couple of weeks and are in talks with multiple institutions and several hospitals in India to ensure that the product is readily available for patients in need. We are also likely to tie up with other partners across the country to increase patient coverage and have been inviting discussions on the same"
Read also: Zydus Life Desidustat gets CDSCO panel nod to treat Anaemia in Kidney Patients
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.