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World’s first generic version of COVID-19 oral drug ‘PAXLOVID’ receives WHO Prequalification

26 December 2022 | News

With the launch of NIRMACOM, Hetero aims to expand access of the ground-breaking antiviral in 95 LMICs including India

image credit- shutterstock

image credit- shutterstock

Indian pharmaceutical company Hetero has announced the receipt of World Health Organisation Prequalification of Medicines Programme (WHO PQ) approval for its generic version of COVID-19 oral antiviral treatment candidate nirmatrelvir.

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.

WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission, such as unvaccinated, aged, or immunosuppressed patients.

The combi pack, launched by Hetero as NIRMACOM, will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet). It is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. NIRMACOM will be manufactured at Hetero’s facilities in 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 low and middle income countries (LMICs).


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