According to the drugmaker’s press statement, this is the first prequalification for a generic version of Pfizer’s COVID-19 oral anti-viral medicine generic Paxlovid which the WHO has dubbed the best therapeutic choice for high-risk patients to date.

Hetero, a city-based prominent pharmaceutical business, reported on Monday that its generic version of COVID-19 oral anti-viral therapy candidate Nirmatrelvir has received World Health Organization Prequalification of Medicines Programme (WHO PQ) clearance.

According to the drugmaker’s press statement, this is the first prequalification for a generic version of Pfizer’s COVID-19 oral anti-viral medicine generic Paxlovid which the WHO has dubbed the best therapeutic choice for high-risk patients to date.

According to the WHO, Nirmatrelvir and Ritonavir are strongly recommended for mild and moderate COVID-19 individuals who are at high risk of hospitalization, such as those who are unvaccinated, elderly, or immunocompromised.

Hetero’s Nirmacom combo pack will comprise Nirmatrelvir 150 mg (2 pills) and Ritonavir 100mg (1 tablet). It is only accessible by prescription and should be started as soon as possible following a COVID-19 diagnosis and within five days of symptom onset.

According to the press statement, Nirmacom will be manufactured at Hetero’s facilities in India.

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 has already received Emergency Use Authorisation (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market Nirmacom, the release added.

Hetero agreed into a non-exclusive voluntary licence arrangement with Medicines Patent Pool (MPP) for the manufacture and distribution in LMICs of a generic version of Pfizer’s COVID-19 oral anti-viral therapy candidate Nirmatrelvir, which is co-packaged with Ritonavir (Nirmatrelvir; Ritonavir) (low and middle income countries).

MPP’s Executive Director, Charles Gore, stated: “We are thrilled that the first generic version of Nirmatrelvir under MPP licence with Pfizer has received WHO quality assurance certification. This is an amazing accomplishment for Hetero, especially given that the sub-licence agreements were disclosed only nine months ago. With COVID-19 cases on the rise once more, we must make therapies widely available in LMICs so that no one is left behind.”