Shilpa Medicare has received U.S Food and Drug Administration tentative (USFDA) approval for its ANDA, Tenofovir Alafenamide Tablets, 25 mg on September 15, 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. The US market for Tenofovir Alafenamide Tablets, 25 mg is around $498.14 million.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.
