Date: August 10, 2026
Product Approval Details
Lupin Limited 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. The approval covers two dosage forms: 5 g/packet and 10 g/packet.
Product Equivalence and Indication
The U.S. FDA approved Lupin's Sodium Zirconium Cyclosilicate for Oral Suspension as bioequivalent to the reference listed drug (RLD) Lokelma® for Oral Suspension of AstraZeneca Pharmaceuticals LP. The product is indicated for the treatment of hyperkalemia in adults.
Market Context
Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma®) had estimated annual sales of USD 568 million in the U.S. based on IQVIA MAT data as of June 2026.
Company Background
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company maintains a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, with strong leadership in the U.S. and India across core therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. The company operates 15 state-of-the-art manufacturing facilities and 6 research centers, employing over 26,000 professionals.
Regulatory Disclosure
The announcement was made pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. The disclosure was signed by Amit Kumar Gupta, Company Secretary & Compliance Officer of Lupin Limited.