Global Pharma Major Lupin Receives U.S. FDA Approval for Sodium Zirconium Cyclosilicate Oral Suspension
Mumbai: Global pharmaceutical major Lupin Limited announced that it has secured approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) pertaining to Sodium Zirconium Cyclosilicate for Oral Suspension. The approval covers both 5 g/packet and 10 g/packet formats of the drug.The U.S. FDA has confirmed that Lupin's Sodium Zirconium Cyclosilicate is bioequivalent to the reference listed drug (RLD), Lokelma®, which is manufactured by AstraZeneca Pharmaceuticals LP. This medication is indicated for the treatment of hyperkalemia in adults.
This approval arrives as an estimated market opportunity, with RLD Lokelma® having anticipated annual sales of USD 568 million in the U.S., according to IQVIA MAT Jun 2026 data.
Lupin Limited maintains a significant presence across various markets, operating out of its global headquarters in Mumbai, India. The company has diversified operations spanning generics, complex generics, specialty medicines, and biosimilars. Lupin is recognized as a leader in cardiovascular, respiratory, diabetes, gastrointestinal, and women's health care sectors within the U.S. and India.
The organization operates 15 state-of-the-art manufacturing facilities and maintains 6 research centers, supported by a dedicated workforce exceeding 26,000 professionals. Lupin also focuses on expanding its healthcare ecosystem through initiatives involving diagnostics, digital health, and patient support programs, while maintaining sustainability as a core pillar of its business strategy.
LUPIN Stock Price Movement
Lupin Limited shares today slipped by 2.69% to settle at ₹2300, having shed ₹63.50 in the post-market session. The stock traded with a volume of 3.76 million shares as it closed lower after falling from its previous close.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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