Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g, indicated for the cleansing of the colon as a preparation for colonoscopy in adults.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g is bioequivalent to the reference listed drug (RLD), Sutab Tablets, 1.479 g/0.225 g/0.188 g of Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets (RLD Sutab) had an estimated annual sale of $132.8 million in the U.S. (IQVIA MAT March 2026).
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.
