Pharmaceuticals
USFDA7 April 2026 at 04:00 pm

Lupin Receives Approval for Dapagliflozin Tablets in the US

AI Summary

Global pharma major Lupin Limited has announced that it has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg and 10 mg. The US FDA has approved Lupin’s Dapagliflozin Tablets as bioequivalent to Farxiga® for the indications in the approved labeling. Lupin Limited, headquartered in Mumbai, India, is a global pharmaceutical leader with products distributed in over 100 markets. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

Key Highlights

  • Lupin Limited receives approval from the US FDA for Dapagliflozin Tablets, 5 mg and 10 mg.
  • The approved Dapagliflozin Tablets are found to be bioequivalent to Farxiga®.
  • Lupin Limited is a global pharmaceutical leader with products in over 100 markets.
  • The company specializes in various pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.