28 July 2022 | News
The tablet to be sold under the brand name Paxzen has bagged CDSCO approval
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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 US FDA-approved state-of-the-art facility in Hyderabad.
This approval by the CDSCO has been granted under the emergency authorisation route considering the unmet medical need in COVID-19 for an effective and affordable therapy for the patients
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 US FDA and with a better safety profile than subsequently approved oral therapies.