Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (US 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 approval represents an important addition to Lupin’s growing portfolio of generic pharmaceutical products in the United States and reinforces the company’s position as a leading global provider of high-quality healthcare solutions.
The approved product is therapeutically equivalent to Sutab® Tablets, manufactured by Azurity Pharmaceuticals, Inc. The medication is indicated for cleansing the colon in adult patients as preparation for colonoscopy procedures. Effective bowel preparation is a critical step in ensuring successful colonoscopy examinations, enabling healthcare professionals to accurately assess and diagnose gastrointestinal conditions.
Lupin has secured a significant competitive advantage through its status as the exclusive first-to-file applicant for the product. This designation provides the company with eligibility for 180 days of generic drug exclusivity in the US market, allowing Lupin to be the sole generic supplier during the exclusivity period following commercial launch.
The product will be manufactured at Lupin’s state-of-the-art pharmaceutical facility in Nagpur, India. The manufacturing site is equipped with advanced production capabilities and operates under stringent quality standards designed to meet global regulatory requirements. The approval further demonstrates the company’s ability to leverage its international manufacturing network to support pharmaceutical markets worldwide.
According to industry estimates, the reference product generated annual US sales of approximately USD 132.8 million for the twelve-month period ending March 2026, highlighting the market opportunity associated with the newly approved generic alternative. The approval aligns with Lupin’s strategy of expanding access to affordable medicines while strengthening its presence in key therapeutic categories. By introducing a lower-cost equivalent to a widely used colonoscopy preparation product, the company aims to support healthcare providers, patients and healthcare systems seeking effective treatment options.
Headquartered in Mumbai, Lupin is recognized as one of the world’s leading pharmaceutical companies, with products distributed in more than 100 countries. The company’s portfolio includes branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients.
Lupin maintains a strong presence across several therapeutic areas, including respiratory care, cardiovascular health, diabetes management, anti-infective therapies, gastrointestinal disorders, central nervous system treatments and women’s health. The company’s extensive global infrastructure includes 15 manufacturing facilities and seven research centers supported by a workforce of more than 24,000 professionals.
