Shilpa Medicare has informed that the Company has received U.S Food and Drug Administration tentative approval for its ANDA, Tenofovir Alafenamide Tablets, 25 mg on 15 Sep 2022. The ANDA was filed as 'First to File' submission on NCE -1 date. Tenofovir Alafenamide Tablets, 25 mg is a generic equivalent of reference listed drug (RLD) Vemlidy® tablets, of Gilead Sciences Inc. used in the treatment of chronic hepatitis B virus infection as recommended in the label approved by FDA. According to IQVIA MAT Q2 2022 data, the US market for Tenofovir Alafenamide Tablets, 25 mg is approximately $498.14 Million.
The above information is a part of company’s filings submitted to BSE.
