Shilpa Medicare gets USFDA tentative approval for Tenofovir Alafenamide Tablets

19 Sep 2022 , 09:17 AM

Shilpa Medicare Ltd informed to the exchanges that it has received U.S Food and Drug Administration tentative 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.

As per the filing, Tenofovir Alafenamide Tablets, 25 mg is a generic equivalent of reference listed drug (RLD) Vemlidy tablets, of Gilead Sciences Inc. which is used in the treatment of chronic hepatitis B virus infection as recommended in the label approved by the FDA.

The US market for Tenofovir Alafenamide Tablets, 25 mg is approximately US$ 498.14 million, according to IQVIA MAT Q2 2022 data.

At around 9:17 AM, Shilpa Medicare Ltd is currently trading at Rs387 per share up by Rs3.35 or 0.87% from its previous closing of Rs383.65 per share on the BSE.

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