Aurobindo gets licence for supply of Pfizer’s Covid pill

Hyderabad: Pharma major Aurobindo Pharma Limited has inked a sub-license agreement with the United Nations-backed public health organisation Medicines Patent Pool (MPP) for manufacturing and supplying a generic version of Pfizer’s oral Covid-19 treatment drug nirmatrelvir to 95 countries, including India.

MPP had earlier signed a voluntary licensing agreement with Pfizer for sub-licencing nirmatrelvir and ritonavir to qualified generic drugmakers, as many as 35 of whom, including India’s Aurobindo Pharma, Torrent Pharma and Cadila Pharmaceuticals, have inked the sub-licencing pact with MPP.

Pfizer’s oral Covid-19 pill Paxlovid comprises nirmatrelvir, which stops the SARS-CoV-2 virus from replicating by inhibiting a protein, and ritonavir, which helps nirmatrelvir stay in the body longer at higher concentrations.

Paxlovid has received emergency use or conditional authorization for Covid-19 treatment in certain populations from USFDA, UK Medicines and Healthcare products Regulatory Agency (UKMHRA) and about 50 other countries.

The generic version of Pfizer’s drug will be manufactured at its manufacturing facilities in India that are approved by global regulatory agencies like USFDA and UKMHRA, Aurobindo said, adding that it has adequate capacities to meet the global demand for the drug across 95 countries, including India.

It said it has backward integration for nirmatrelvir and ritonavir molecules, with in-house API manufacturing facilities that give it stronger control over supply chain and cost efficiencies.

Aurobindo Pharma vice-chairman & MD K Nithyananda Reddy said the company has developed and commercialized ritonavir which is used as a booster along with nirmatrelvir. “We will soon make it available commercially at an affordable price for these (low & middle income) markets after due process of registration and approval in various countries, including India,” Reddy said, adding that this combination will be a valuable addition to Aurobindo’s Covid-19 portfolio.