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What is the story about?
Lupin said it 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 company said the product is bioequivalent to the reference listed drug, Sutab tablets of Azurity Pharmaceuticals, Inc.
Lupin added that it is the exclusive first-to-file applicant for the product and is eligible for 180-day generic drug exclusivity. The tablets will be manufactured at the company’s Nagpur facility in India.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for cleansing of the colon as preparation for colonoscopy in adults.
According to IQVIA MAT March 2026 data cited by the company, the reference drug had estimated annual sales of $132.8 million in the US.
Earlier, on May 8, CNBC TV18 had reported that Mumbai-based pharmaceutical major Lupin expects its US business to remain above the $1 billion mark in FY27 , supported by products such as Tolvaptan, Mirabegron and recent injectable launches.
Vinita Gupta, Chief Executive Officer (CEO) of Lupin stated the upcoming contribution from biosimilars and specialty products, which Lupin believes will become an increasingly important growth driver over the next few years.
Shares of Lupin closed marginally lower at ₹2,275 on the NSE on Friday, down 0.06% or ₹1.40 from the previous close.
Also Read: India’s AI deficit narrative may be exaggerated
The company said the product is bioequivalent to the reference listed drug, Sutab tablets of Azurity Pharmaceuticals, Inc.
Lupin added that it is the exclusive first-to-file applicant for the product and is eligible for 180-day generic drug exclusivity. The tablets will be manufactured at the company’s Nagpur facility in India.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for cleansing of the colon as preparation for colonoscopy in adults.
According to IQVIA MAT March 2026 data cited by the company, the reference drug had estimated annual sales of $132.8 million in the US.
Earlier, on May 8, CNBC TV18 had reported that Mumbai-based pharmaceutical major Lupin expects its US business to remain above the $1 billion mark in FY27 , supported by products such as Tolvaptan, Mirabegron and recent injectable launches.
Vinita Gupta, Chief Executive Officer (CEO) of Lupin stated the upcoming contribution from biosimilars and specialty products, which Lupin believes will become an increasingly important growth driver over the next few years.
Shares of Lupin closed marginally lower at ₹2,275 on the NSE on Friday, down 0.06% or ₹1.40 from the previous close.
Also Read: India’s AI deficit narrative may be exaggerated
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