Shilpa Medicare: Intimation U/R 30 Of The SEBI (LODR) Regulations 2015- Reg. | Value Research

Shilpa Medicare: Intimation U/R 30 Of The SEBI (LODR) Regulations 2015- Reg.

This is to inform you 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 US$ 498.14 Million.This is for your information and doing the needful.

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