According to reports from PRNewswire, Lupin has received approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension in 5 g/packet and 10 g/packet strengths. The approval covers two dosage strengths: 5 g/packet and 10 g/packet. The FDA has determined these products are bioequivalent to the reference listed drug (RLD) Lokelma for Oral Suspension of AstraZeneca Pharmaceuticals LP.
As reported by PRNewswire, the approved product is indicated for the treatment of hyperkalemia in adults. Hyperkalemia is a medical condition characterized by elevated potassium levels in the blood, which can be life-threatening if not properly managed. The oral suspension formulation provides an alternative treatment option for patients requiring potassium level control.
According to PRNewswire, Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma) had estimated annual sales of USD 568 million in the U.S. (IQVIA MAT June 2026). This substantial market size represents a significant opportunity for Lupin to capture market share in the hyperkalemia treatment segment. The approval positions the company to compete directly with the reference listed drug in the U.S. market.
As reported by CNBC TV18, Lupin delivered robust first quarter results with net profit increasing 16.1% year-on-year to ₹1,415 crore compared with ₹1,219 crore in the year-ago quarter. Revenue from operations surged 33.3% YoY to ₹8,217 crore from ₹6,164 crore, supported by healthy growth across key markets. Operating performance was even stronger, with EBITDA rising 47.3% to ₹2,390 crore from ₹1,623 crore a year earlier, resulting in EBITDA margin expansion of 280 basis points to 29.1% compared with 26.3% in Q1FY26.
According to CNBC TV18, the US business remained the largest contributor with revenue rising to $366 million from $282 million a year ago. Domestic sales in India increased 14% to ₹2,379.6 crore, while other developed markets recorded 48.3% growth to ₹1,149.4 crore. Emerging markets also delivered strong momentum with revenue climbing 51.7% to ₹989.7 crore. Brokerage firm Macquarie has an 'Outperform' rating on Lupin with a price target of ₹2,750, noting that the company reported a strong first quarter with revenue, EBITDA and profit after tax exceeding estimates by 7%, 23% and 17% respectively. Shares of Lupin ended at ₹2,275.00, down by ₹85.00, or 3.60% on the BSE.
