HYDERABAD: Apart from Hyderabad-based pharma major Aurobindo Pharma Limited, other city-based pharma players like Granules India Ltd, MSN Group and SMS Pharmaceuticals too have received licences from the UN-backed Medicines Patent Pool (MPP) to manufacture and supply a generic version of nirmatrelvir, a key component of Pfizer’s oral Covid-19 drug Paxlovid, to 95 countries, including India.
As part of the Pfizer pill, nirmatrelvir is co-packaged with ritonavir. While nirmatrelvir stops the SARSCoV-2 virus from replicating by inhibiting a protein, ritonavir helps nirmatrelvir remain in the body longer at higher concentrations.
The recommended dosage is 300 mg (two 150mg tablets) of nirmatrelvir with ritonavir 100mg (one tablet) twice daily for five days. About three dozen generic pharma players globally have inked licencing pacts with MPP, including about 19 from India.
GIL said the licenses granted by MPP are applicable for both active pharmaceutical ingredients (API) and finished products, in tablet form, of nirmatrelvir and ritonavir and that it will be manufacturing the drug at its manufacturing facilities in India that are approved by global regulatory agencies including USFDA.
MSN Group said it will be launching the drug in India as Paxvid, which will come as a co-pack having two tablets of nirmatrelvir (150 mg each) and one tablet of ritonavir (100 mg each), after receiving approval from the Indian drug regulator. It said it has developed nirmatrelvir API and formulation completely in-house and will be manufacturing it at its USFDA and EU approved facility here.
SMS Pharma said the oral treatment showed an 89% reduction in risk of Covid-19 related hospitalisation of death for any cause compared to placebo based on the Phase 2/3 study conducted by Pfizer.
