Hyderabad-based Zenara Pharma gets nod to manufacture Covid-19 antiviral pills

The tablets will be sold under the brand name Paxzen, and are is being manufactured at Zenara Pharma’s USFDA-approved facility in Hyderabad.

BySumit Jha

Published Jul 28, 2022 | 6:59 PMUpdatedJul 28, 2022 | 6:59 PM

Zenara Pharma in a press statement said that they have received the approval to manufacture and sell combination packs of Nirmatrelvir and Ritonavir tablets.

Hyderabad-based Zenara Pharma, a subsidiary owned by Biophore India Pharmaceuticals, has received emergency-use authorization from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market in India a generic version of Pfizer’s Covid-19 pill Paxlovid for the treatment of patients with mild symptoms of the disease.

Zenara Pharma, in a statement, said it has received the approval to manufacture and sell combination packs of Nirmatrelvir and Ritonavir tablets.

The pharmaceutical company added that the tablets would be sold under the brand name Paxzen, and that it was being manufactured at Zenara’s USFDA-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,” Zenara Pharma Chief Executive Officer Srinivas Arutla said in the statement.

Cofounder and Managing Director Jagadeesh Babu Rangisetty was quoted by the statement as saying, “We believe Paxzen is an extremely effective treatment option against Covid-19.”

He added: “It is a very complex product to develop and manufacture. We brought this product to the market in record time, and this is one of the first approvals of this product in India.”

According to Zenara Pharma, the tablets and active pharmaceutical ingredients (APIs) would be made entirely in India.

The combination pack of Nirmatrelvir and Ritonavir tablets is the generic equivalent of Pfizer’s Paxlovid, which was given to US President Joe Biden when he came down with Covid-19.

The United States Food and Drug Administration (USFDA) approved the combination pack of Nirmatrelvir and Ritonavir tablets for Covid-1919 treatment in December 2021.

It should be noted that in a study, the Nirmatrelvir and Ritonavir tablets reduce the risk of hospitalisation or death by 89 percent among patients who were unvaccinated and not hospitalised.