en.Wedoany.com Reported - On August 10, Lupin Limited (Lupin) announced that its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate Oral Suspension has been approved by the U.S. Food and Drug Administration (U.S. FDA), with approved strengths of 5 g/sachet and 10 g/sachet. The product is bioequivalent to the reference listed drug Lokelma® Oral Suspension, manufactured by AstraZeneca Pharmaceuticals LP, and is indicated for the treatment of hyperkalemia in adults.

The estimated annual U.S. sales of Sodium Zirconium Cyclosilicate Oral Suspension (reference listed drug Lokelma®) are $568 million (IQVIA MAT June 2026).

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, operating in India, the United States, and other developed and emerging markets, with products distributed across more than 100 markets. The company's business covers generics, complex generics, specialty pharmaceuticals, and biosimilars, with a product portfolio in therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. Currently, Lupin operates 15 manufacturing facilities and 6 research centers, employs over 26,000 people, and is expanding its healthcare ecosystem through diagnostics, digital health, patient support programs, and disease management initiatives.