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.
|