Lupin Announces the Approval of Sodium Zirconium Cyclosilicate for Oral Suspension in the United States

MUMBAI, India and NAPLES, Fla., Aug. 10, 2026 /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet.

The U.S. FDA has approved Lupin's Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet as bioequivalent to the reference listed drug (RLD) Lokelma® for Oral Suspension of AstraZeneca Pharmaceuticals LP and is indicated for the treatment of hyperkalemia in adults.

Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma®) had estimated annual sales of USD 568 million in the U.S. (IQVIA MAT Jun 2026).

About Lupin

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, with products distributed in over 100 markets. Lupin has a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, and continues to strengthen its market position through a differentiated portfolio. The company maintains strong leadership in the U.S. and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. 15 state-of-the-art manufacturing facilities support sustainable operations, with 6 research centers and a dedicated workforce of over 26,000 professionals. Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives. Sustainability continues to be a core pillar of the company's business strategy.

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

Safe Harbor Statement
Lokelma® is a registered trademark of ZS Pharma, Inc.

SOURCE Lupin Pharmaceuticals, Inc.