Granules India Receives Licences from MPP to Market generic of Pfizers Paxlovid
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.
Hyderabad: Granules India ltd., (GIL) 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.
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Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best in class facilities and commitment to operational excellence, quality, and customer service. Granules are among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Granules products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 75+ countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
Read Also - USFDA issues 3 minor observations to Granules India arm in pre-approval inspection
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