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Hyderabad, July 28
Zenara Pharma, a subsidiary of Biophore India Pharmaceuticals, has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Nirmatrelvir and Ritonavir tablets in a combo pack as a treatment option for patients with mild to moderate symptoms of Covid-19.
The tablets, which will be sold under the brand name ‘Paxzen’, are being manufactured at Zenara’s US FDA-approved facility in Hyderabad.
“We expect to launch Paxzen in the next couple of weeks and are in talks with multiple institutions and hospitals in India to ensure that the product is readily available for patients in need,” Srinivas Arutla, Chief Executive Officer of Zenara Pharma, said.
“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 in India,” Jagadeesh Babu Rangisetty, Co-founder and Managing Director at Zenara Pharma, said.
“We believe Paxzen is an extremely effective treatment option against Covid-19. It is a very complex 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,” he said in a statement on Thursday.
The product, being the first oral pill, received FDA approval in December 2021 in the US.
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