‘s anti viral drug Paxlovid.
The company said that Nirmatrelvir and Ritonavir tablets in a combi pack as a treatment option for patients with mild to moderate symptoms of Covid-19 will be available soon.
The approval has been granted under the emergency authorization route considering the unmet medical need in Covid-19 for the patients.
Multiple drug companies based in India have got sub-licenses from Medicines Patent Pool – a UN-backed public health organisation to manufacture and distribute the generic versions of oral antiviral Covid-19 medication in 95 low and middle income countries (LMIC) including India.
Zenara is not a sub licensee though.
Jagadeesh Babu Rangisetty, Co-founder and Managing Director at Zenara Pharma, believes that Paxzen is an extremely “effective treatment option” against Covid-19 and, at the same time, 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. 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,” he said in a statement.
So far, Hetero pharma has got the approval for the same drug but is yet to launch it.
The drug was first approved by the US FDA in Dec 2021and is indicated for the treatment of mild-to-moderate Covid-19 in adults.
The company is expected to launch the drug in the next could of weeks, said Srinivas Arutla, CEO, Zenara Pharma.
“We 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,” he said.