Granules India ltd has received a license from Medicines Patent Pool (MPP) to manufacture and market generic versions of Pfizer’s oral treatment nirmatrelvir which will be copackaged with ritonavir for treatment of COVID-19. The licenses are applicable for both active pharmaceutical ingredients (API) and finished products, in tablet form, of nirmatrelvir; ritonavir.
Nirmatrelvir is an inhibitor of SARS-CoV-2 3CL-like protease that prevents polyprotein cleavage of proteins necessary for SARS-CoV-2 genome replication. Nirmatrelvir in combination with ritonavir (under the Pfizer brand name PAXLOVID™) is currently approved for emergency use, in the US, Canada and many other countries for the treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients.
The product will be made at Granules manufacturing facilities in India that are approved by global regulatory agencies including USFDA. The license received by GIL will enable the company to launch the product in India and 94 other countries worldwide.