Cadila, Aurobindo, Torrent Receive License to Manufacture Generic Version of Pfizer’s Oral COVID Drug

The companies won the bid after signing a sub-licensing deal with the Medicines Patent Pool (MPP), a United Nations-based public health organization working to expand access to life-saving medicines for low- and middle-income countries improve.

Leading drugmakers Cadila Pharmaceuticals, Aurobindo Pharma and Torrent Pharmaceuticals announced on Thursday that they have been licensed to manufacture a generic version of Pfizer’s oral antiviral COVID-19 drug PAXLOVID and will sell it in 95 countries including India.

The companies won the bid after signing a sub-licensing deal with the Medicines Patent Pool (MPP), a United Nations-based public health organization working to expand access to life-saving medicines for low- and middle-income countries improve.

Previously, MPP had signed a voluntary license agreement with Pfizer to sub-license this COVID-19 treatment product to qualifying generic manufacturers.

“We are excited to partner with MPP to manufacture a generic version of the innovative drug PAXLOVID for the global community and help reduce the health burden of the pandemic.

“We reaffirm our commitment to bringing affordable innovation to the bottom of society,” said Rajiv Modi, CMD of Cadila Pharmaceuticals, in a statement.

Cadila said it will serve Indian and export markets as many countries with high COVID-19 burdens lack access to an effective therapy.

Pfizer markets its oral COVID-19 treatment under the name PAXLOVID, which has been approved by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of COVID-19. 19 is allowed. 19 in patients at high risk for serious disease.

The USFDA was the first regulatory agency to approve the use of PAXLOVID, nirmatrelvir tablets, and ritonavir tablets packaged together for oral use for the treatment of adults with mild to moderate COVID-19 and high-risk pediatric patients over the age of 12 and weighing 12 years has approved at least 40kg.

“Aurobindo has already developed and commercialized ritonavir, which is used together with nirmatrelvir as a booster.

“We look forward to working on this molecule and will soon make it commercially available to these markets at an affordable price after a proper registration and approval process in various countries including DCGI in India,” said Aurobindo Vice-Chairman and Managing Director K Nithyananda Reddy.

Reddy added that this combination, along with Molnaflu (molnupiravir) for the treatment of COVID-19, will be a very valuable addition to our portfolio.

For nirmatrelvir and ritonavir molecules, like other antivirals, the company enjoys backward integration with in-house API manufacturing, which provides it with greater supply chain control and cost efficiencies, the company said.

Torrent Pharmaceuticals stated that it has entered into a non-exclusive, non-transferable, non-sublicensable license agreement to use the patents and know-how relating to the combination of nirmatrelvir and MPP to manufacture and commercialize the generic version of PAXLOVID. This is to be co-packaged and administered with ritonavir in 95 low- and middle-income countries, including India, for the treatment and/or prevention of COVID-19 caused by SARSCoV-2.

Commenting on the agreement, Aman Mehta (Executive Director), “We are pleased to enter into this agreement with MPP and are part of our ongoing effort to make COVID-19 treatments as accessible as possible for patients.” The company will be the product launch after it has received the necessary regulatory approvals.

https://www.financialexpress.com/lifestyle/health/cadila-aurobindo-torrent-get-licence-to-make-generic-version-of-pfizers-oral-covid-medication/2464449/ Cadila, Aurobindo, Torrent Receive License to Manufacture Generic Version of Pfizer’s Oral COVID Drug

Chris Barrese

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