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

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

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

PR Newswire

MUMBAI, India and NAPLES, Fla., Aug. 10, 2026

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.

 

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SOURCE Lupin Pharmaceuticals, Inc.

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