Hetero emerges 1st in world to bag WHO PQ for generic version of Pfizer’s Covid-19 oral drug Paxlovid | India News – Times of India

HYDERABAD: Pharma player Hetero Group on Monday said it has emerged as the first in the world to receive the World Health Organisation’s prequalification of medicines programme (WHO-PQ) for its generic version of Covid-19 oral antiviral treatment candidate Nirmatrelvir, which along with Ritonavir is used as part of Pfizer’s Paxlovid.
“This is the first prequalification for a generic version of Pfizer’s Covid-19 oral antiviral drug Paxlovid, which the WHO called the best therapeutic choice for high-risk patients to date,” Hetero said.
The company said it will be rolling out its generic combi-pack under the NIRMACOM brand that will contain 150mg tablets of Nirmatrelvir and 100mg tablets of Ritonavir. The tablets will be available on prescription only and have to be started within five days of onset of Covid-19 symptoms, it added. According to Hetero, Nirmacom will be manufactured at its facilities in Hyderabad.
Terming the WHO PQ for Nirmacom as a significant milestone in the fight against Covid-19, Hetero Group managing director Vamsi Krishna Bandi said: “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.”
Medicines Patent Pool (MPP) executive director Charles Gore 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 sub-licence 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 had entered into a non-exclusive voluntary licensing agreement with MPP for the manufacture and sale of a generic version of Pfizer’s Covid-19 oral antiviral treatment candidate nirmatrelvir, which is co-packaged with ritonavir, in LMICs.
Hetero has already received emergency use authorization (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market NIRMACOM.
WHO had made a strong recommendation for Nirmatrelvir and Ritonavir for patients suffering from mild and moderate Covid-19 that were at highest risk of hospital admission, such as unvaccinated, aged, or immunosuppressed patients.

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