Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop
Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages
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The Indian companies that have been granted licences are Cipla, Sun Pharma, Laurus Labs, Divis Labs, Glenmark, Cadila, Torrent, Emcure, McLeods, SMS Pharmaceuticals, Strides, Biocon, Aurobindo Pharma, Hetero, Granules, Amneal, MSN, Arene Life Sciences and Viatris
The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
The data should be submitted by August 12th 2021
NATCO Pharmaceuticals, Hyderabad; Alembic Pharmaceuticals, Vadodara; Gufic Biosciences Ltd., Gujarat; Emcure Pharmaceuticals, Pune; and Lyka, Gujarat are new manufacturers
The country has constantly worked with the spirit of public-private partnership
Investment demonstrates confidence in America’s commitment to science and innovation
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