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Lupin Secures US FDA Approval for Dapagliflozin Tablets in US

Lupin Secures US FDA Approval for Dapagliflozin Tablets in US

Lupin announced that it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, 5 mg and 10 mg.

The FDA has approved Lupin’s Dapagliflozin Tablets, 5 mg and 10 mg, as bioequivalent to Farxiga for the indications in the approved labeling.

Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and Active Pharmaceutical Ingredients (APIs).

More news about: quality / gmp | Published by News Bureau | April - 08 - 2026

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