HYDERABAD: Hyderabad-based Zenara Pharma, a fully-owned subsidiary of Biophore India Pharmaceuticals, on Thursday said it has received emergency use authorisation (EUA) from the Central Drugs Standard Control Organization (CDSCO) to manufacture and market in India a generic version of Pfizer’s Covid-19 pill Paxlovid for the treatment of patients with mild to moderate Covid-19 symptoms.
The approval is for Nirmatrelvir and Ritonavir tablets in a combipack and will be sold under the Paxzen brand in India. The drug is being manufactured at Zenara’s USFDA approved facility in Hyderabad.
Pointing out that the company was one of the first companies to bring the drug to market in India in record time, Zenara Pharma co-founder & managing director Jagadeesh Babu Rangisetty said the company has its own in-house active pharmaceutical ingredients pipeline for the drug and was not dependent on imports for its production.
“This will ensure stability and rapid production and availability of this treatment for the Indian market,” he said.
The breakthrough approval in the US for Paxlovid was given by the USFDA in December 2021. It was the first oral pill that had been approved by USFDA and is claimed to have a better safety profile than subsequently approved oral therapies.
Zenara Pharma CEO Dr Srinivas Arutla said the company expects to launch Paxzen in the next couple of weeks and is in talks with multiple institutions and hospitals in the country to ensure ready availability for patients in need.
