Lupin shares in focus on Monday after USFDA approval for Generic Sutab tablets

Lupin Ltd shares are expected to stay in focus on Monday after the pharmaceutical company revealed that it has gained permission from the United States. The US Food and Drug Administration (FDA) has approved an Abbreviated New Drug Application (ANDA) for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g.

The authorized medication is a generic form of Sutab that is used to cleanse the colon prior to colonoscopy treatments in adults.

Lupin stated that the product was authorized as a bioequivalent to Azurity Pharmaceuticals' reference listed drug (RLD), Sutab tablets. The firm has obtained the designation of exclusive first-to-file application, allowing it to enjoy 180 days of generic medicine exclusivity in the United States.

The medication will be manufactured at the company's Nagpur plant in India, further increasing its foothold in the regulated US pharmaceutical industry.

According to IQVIA MAT data for March 2026, the reference medicine Sutab generated an anticipated yearly sales of $132.8 million in the United States, indicating a large market potential for Lupin upon the launch of its generic counterpart.

Lupin's recent clearance is likely to help drive commercial development in the United States, as the firm expands its portfolio of complicated and specialty generic medications.

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