The pharmaceutical company on Friday announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its ANDA, Tenofovir Alafenamide Tablets.
The Abbreviated New Drug Application (ANDA) was filed as 'first to file' submission on NCE -1 date, said the drug maker.Tenofovir Alafenamide Tablets is a generic equivalent of reference listed drug (RLD) Vemlidy tablets of Gilead Sciences Inc.
Tenofovir alafenamide is used for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
According to IQVIA MAT Q2 2022 data, Tenofovir Alafenamide Tablets had revenue of $498.14 million in the United States.
Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.
The company's consolidated net profit tumbled 46.5% to Rs 0.85 crore on 10% increase in net sales to Rs 261.16 crore in Q1 FY23 over Q1 FY22.
Shares of Shilpa Medicare were down 0.20% to Rs 387.25 on the BSE.
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