Lupin Limited , a global pharmaceutical leader, has achieved a significant milestone in its product portfolio expansion. The company recently announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for Oral Suspension, 1 mg/mL.

Key Highlights

• Lupin's Rivaroxaban for Oral Suspension is bioequivalent to Janssen Pharmaceuticals, Inc.'s Xarelto® for Oral Suspension, 1 mg/mL.
• The product will be manufactured at Lupin's Chhatrapati Sambhajinagar facility in India.
• Estimated annual sales of Rivaroxaban for Oral Suspension, 1 mg/mL in the U.S. market stand at USD 11.00 million (IQVIA MAT July 2025).

Therapeutic Applications

Rivaroxaban for Oral Suspension is indicated for:

1. Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years, after at least 5 days of initial parenteral anticoagulant treatment.
2. Treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

Market Impact

This approval marks an important addition to Lupin's cardiovascular therapy area, one of the company's key focus areas. The introduction of Rivaroxaban for Oral Suspension will provide healthcare professionals with an additional option for pediatric patients requiring anticoagulant therapy.

About Lupin Limited

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a presence in over 100 markets. The company specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin employs over 24,000 professionals dedicated to improving patient health outcomes. The company has a strong presence in India and the United States across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.

This latest FDA approval reinforces Lupin's commitment to expanding its product offerings and strengthening its position in the global pharmaceutical market, particularly in the critical area of pediatric care.

Lupin Limited , a global pharmaceutical leader, has announced a significant move to strengthen its presence in the European ophthalmology market. The company's wholly-owned subsidiary, Nanomi B.V., has entered into a definitive agreement to acquire VISUfarma B.V., a Netherlands-based specialty pharmaceutical company, for an enterprise value of €190 million.

Strategic Expansion into European Ophthalmology

The acquisition of VISUfarma aligns with Lupin's strategy to expand its European business and advance its global specialty franchise in ophthalmology. VISUfarma, founded in 2016, has established a strong presence across major European countries, including Italy, the UK, Spain, Germany, and France.

VISUfarma's Portfolio and Performance

VISUfarma offers a comprehensive portfolio of over 60 branded ophthalmology products, covering key areas such as:

• Dry eye treatments
• Glaucoma care
• Eyelid hygiene
• Blepharitis management
• Retinal health solutions
• Specialized nutraceuticals

The company has demonstrated consistent financial performance, with revenues of:

Financial Details and Funding

Lupin will finance the acquisition through existing cash on its balance sheet. The transaction, valued at €190 million enterprise value, is expected to be accretive to Lupin's growth and margin profile.

Market Expansion and Growth Opportunities

This strategic move will provide Lupin with:

1. Direct presence in major European markets
2. Opportunities for business diversification
3. A platform to accelerate expansion into the specialty ophthalmology segment across regions

Regulatory Approvals and Timeline

The acquisition requires approval from national authorities for foreign direct investment in Germany and notification in Spain. Lupin anticipates completing the transaction by the end of 2025, subject to certain closing conditions.

Management Perspectives

Vinita Gupta, CEO of Lupin, expressed enthusiasm about the acquisition, stating, "We are delighted to welcome VISUfarma into the Lupin family. This acquisition strengthens our commitment to delivering innovative medicines to the patients and communities we serve. Beyond being immediately accretive, it also broadens our presence in Europe and further builds our specialty franchise in Ophthalmology."

Paolo Cioccetti, CEO Italy of VISUfarma, added, "Combining with Lupin represents an exciting new chapter for VISUfarma. As part of Lupin's ophthalmology operations, we will build towards a global ophthalmology franchise with a commitment to advancing eye care and improving patient outcomes."

Market Outlook

The global ophthalmology market, currently valued at approximately €28 billion, is experiencing significant growth driven by an aging global population, increasing incidence of diabetes-related eye complications, and growing awareness of preventive care. Lupin's acquisition of VISUfarma positions the company to capitalize on these trends and establish a strong presence in the attractive and growing European ophthalmology market.

This strategic acquisition marks a significant step for Lupin in expanding its specialty pharmaceutical portfolio and strengthening its position in the European healthcare landscape.