The approval by the Central Drugs Standard Control Organisation (CDSCO) has been granted under the emergency authorisation route, Zenara Pharma said in a statement.
Zenara Pharma on Thursday said it has received the CDSCO approval to manufacture and sell combination packs of Nirmatrelvir and Ritonavir tablets, indicated as an option for patients with mild to moderate COVID-19 symptoms.
The tablets will be sold under the brand ‘Paxzen’ and are being manufactured at the company’s USFDA-approved facility in Hyderabad, it added.
The combination pack of Nirmatrelvir and Ritonavir tablets is the generic equivalent of Pfizer’s Paxlovid, which has been approved by the United States Food and Drug Administration (USFDA) for COVID-19 treatment, it added.
“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,” Zenara Pharma CEO Srinivas Arutla said.
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