Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga Tablets, 5 mg, and 10 mg of AstraZeneca AB. This product will be manufactured at Lupin’s Pithampur facility in India. Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of $7282 million in the U.S. (IQVIA MAT September 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
