Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g. The product is bioequivalent to the reference listed drug Sutab Tablets, manufactured by Azurity Pharmaceuticals, Inc.
Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market. The tablets will be manufactured at Lupin's manufacturing facility in Nagpur, India.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for colon cleansing as a preparation for colonoscopy in adults. The reference listed drug Sutab had an estimated annual sale of USD 132.8 million in the U.S. based on IQVIA MAT March 2026 data.
The U.S. FDA approval marks an addition to Lupin's generic product portfolio in the United States. Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets worldwide.
Lupin specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients across therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin operates 15 manufacturing sites and 7 research centers globally with a workforce of over 24,000 professionals.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.