Lupin Limited has informed the Exchange regarding a press release dated May 29, 2026, titled "Lupin Receives Approval from U.S. FDA for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets".
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Lupin Limited has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets (1.479 g/0.225 g/0.188 g). The product is bioequivalent to Sutab® Tablets of Azurity Pharmaceuticals, used for colon cleansing before colonoscopy in adults. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. The product will be manufactured at Lupin's Nagpur facility in India. The U.S. market for this product was estimated at USD 132.8 million annually as of IQVIA MAT March 2026.
This FDA approval gives Lupin exclusive market entry for this generic drug in the U.S. for 180 days, allowing the company to capture a share of a USD 132.8 million market before generics competition intensifies, which could positively impact revenue.