Lupin receives Tentative Approval from U.S. FDA for Tenofovir Alafenamide Tablets

Tenofovir Alafenamide Tablets (RLD: Vemlidy® Tablets) had estimated annual sales of USD484.2 million in the U.S. (IQVIA MAT December 2021).

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Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Tenofovir Alafenamide Tablets, 25 mg, to market a generic equivalent of Vemlidy® Tablets, 25 mg, of Gilead Sciences, Inc. (Gilead). This product will be manufactured at Lu pin’s Nagpur facility in India.

Tenofovir Alafenamide Tablets (RLD: Vemlidy® Tablets) had estimated annual sales of USD484.2 million in the U.S. (IQVIA MAT December 2021).

Shares of Lupin Ltd was last trading in BSE at ₹772.35 as compared to the previous close of ₹773.70. The total number of shares traded during the day was 49690 in over 2370 trades.

The stock last hit in BSE,

  • Intraday High of ₹ 779.40
  • Intraday low of ₹ 765.80