Hyderabad-based Zenara Pharma has received Central Drugs Standard Control Organization (CDSCO) approval to manufacture and market a generic version of Pfizer’s COVID drug Paxlovid.
Granted under the emergency authorisation route, the CDSCO approval is for manufacturing and marketing Nirmatrelvir and Ritonavir tablets in a combi pack as a treatment option for patients with mild to moderate symptoms of Covid-19. The product will be sold under the brand name Paxzen and being manufactured at the company’s USFDA approved facility in Hyderabad, Zenara said on Thursday.
“We have brought this product to the market in record time and this is one of the first approvals of this product in India,” co-founder and MD Jagadeesh Babu Rangisetty said. We believe Paxzen is an extremely effective treatment option against COVID-19 and, at the same time, is a very complex product to develop and manufacture
Stating that is a very complex product to develop and manufacture, he said Zenara has in-house API and not dependent on imports for the production. “We believe that this will ensure stability, rapid production and availability of the product in the Indian market,” he said.
CEO Srinivas Arutla said Paxzen is expected to be launched in next couple of weeks and the company is in discussions with multiple institutions and hospitals in the country to ensure that the product is readily available for patients in need. A wholly owned subsidiary of Biophore India Pharmaceuticals, Zenara’s product portfolio primarily consists of tablets and capsules. It has capabilities to manufacture oral solutions as well, the company said.
Pfizer’s Paxlovid got approval in the U.S., from the US Food and Drug Administration, in Dec 2021. It was the first oral pill, for Covid-19, to be approved by USFDA and has a better safety profile than subsequently approved oral therapies, Zenara said.
