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Lupin gets USFDA’s nod for Sodium Zirconium Cyclosilicate for Oral Suspension in US

10 Aug 2026 Evaluate

Lupin has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet. 

The USFDA has approved the company’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 $568 million in the U.S. (IQVIA MAT Jun 2026).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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