FIRST: Hetero wins WHO Prequalification for generic version of Pfizer COVID drug Paxlovid

Dr. Vamsi Krishna Bandi, Managing Director, Hetero Group of Companies, said: "WHO Prequalification for NIRMACOM is a significant milestone in the fight against COVID-19 as it allows us to expand access to this important innovative antiretroviral drug to people in need. We are committed to making NIRMACOM available faster at affordable prices across 95 LMICs including India."

Hetero entered into a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) for manufacturing and sale of a generic version of Pfizer's COVID-19 oral antiviral treatment candidate nirmatrelvir, which is co-packaged with ritonavir (nirmatrelvir; ritonavir), in LMICs.

Charles Gore, Executive Director of MPP said: "We are delighted to see the first generic version of nirmatrelvir under MPP license with Pfizer, receive quality assurance approval from WHO. This is an impressive achievement from Hetero as we announced the sublicence agreements just nine months ago. With cases of COVID-19 again on the rise we need to make treatments readily available in LMICs so no one is left behind."

Hetero has already received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market NIRMACOM.