Lupin Receives U.S. FDA Approval for Sodium Zirconium Cyclosilicate Oral Suspension

New Generic Treatment Approved for Hyperkalemia in Adults

Lupin Limited has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Sodium Zirconium Cyclosilicate for Oral Suspension.

The approved product is available in two strengths: 5 g per packet and 10 g per packet.

The approval gives Lupin another product for the U.S. market and expands its portfolio of treatments for cardiovascular and related health conditions.

Sodium Zirconium Cyclosilicate Approved as a Generic Version of Lokelma

The U.S. FDA has approved Lupin's Sodium Zirconium Cyclosilicate for Oral Suspension as bioequivalent to Lokelma, the reference listed drug (RLD) marketed by AstraZeneca Pharmaceuticals LP.

The product is indicated for the treatment of hyperkalemia in adults.

Hyperkalemia is a condition in which the level of potassium in the blood becomes too high. Elevated potassium levels can affect the normal functioning of the heart and may require medical treatment.

Lupin's product will be available as an oral suspension in 5 g and 10 g packet strengths.

What Is Hyperkalemia?

Potassium is an important mineral that helps the body maintain normal nerve, muscle and heart function.

However, when potassium levels in the blood become too high, it can create health risks. People with certain kidney problems and other medical conditions can be more likely to develop hyperkalemia.

Treatment depends on the patient's condition and the severity of the potassium increase.

Sodium zirconium cyclosilicate is designed to help lower elevated potassium levels by binding potassium in the gastrointestinal tract, allowing it to be removed from the body.

Lupin Expands Its U.S. Product Portfolio

The latest FDA approval adds another product to Lupin's growing portfolio in the United States.

The company has a strong presence in the U.S. pharmaceutical market and focuses on areas including cardiovascular disease, respiratory conditions, diabetes, gastrointestinal disorders and women's health.

The approval of sodium zirconium cyclosilicate also adds to Lupin's portfolio of generic and complex pharmaceutical products.

Two Strengths Available for the Oral Suspension

Lupin's approved product will be supplied in two strengths:

• 5 g per packet
• 10 g per packet

The availability of different strengths allows healthcare professionals to select the appropriate dose based on the patient's treatment requirements.

The product is administered orally as a suspension.

Lupin's Presence Across Global Markets

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India.

The company operates across India, the United States, other developed markets and emerging markets, with its products distributed in more than 100 countries.

Its portfolio includes generics, complex generics, specialty medicines and biosimilars.

Lupin also has a strong position in major therapeutic areas such as cardiovascular care, respiratory health, diabetes, gastrointestinal diseases and women's health.

Manufacturing and Research Network

Lupin operates 15 manufacturing facilities supported by six research centres.

The company has a workforce of more than 26,000 professionals working across its global operations.

Its research and manufacturing infrastructure supports the development, production and supply of medicines across different markets.

The company is also expanding its healthcare activities beyond traditional pharmaceuticals through diagnostics, digital health, patient-support programs and disease management initiatives.

Focus on Expanding Healthcare Access

Lupin continues to focus on building a diversified pharmaceutical portfolio while expanding access to medicines across global markets.

The approval of Sodium Zirconium Cyclosilicate for Oral Suspension adds another treatment option for adults with hyperkalemia in the U.S. market and strengthens Lupin's portfolio in an important therapeutic area.

The company also continues to focus on sustainability as part of its broader business strategy.

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