21 Mar 2022 , 03:23 PM
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 PAXLOVIDTM) 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 India (GIL) manufacturing facilities in India that are approved by global regulatory agencies including the USFDA. The license received by GIL will enable the company to launch the product in India and 94 other countries worldwide.
The drug maker reported a 31.2% fall in consolidated net profit to Rs 101 crore in Q3 FY22 from Rs 147 crore posted in Q3 FY21. Income from operations grew by 18% year on year to Rs 997 crore in Q3 FY22 as compared to Rs 845 crore posted in Q3 FY21.
Hyderabad-based Granules India is a vertically integrated fast growing Indian pharmaceutical company. It is present in the manufacturing of entire value chain – from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).
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