Lupin Limited , a global pharmaceutical leader, has announced the launch of Glucagon for Injection USP, 1mg/vial packaged in an emergency kit in the United States market. This strategic move positions Lupin to tap into a significant market opportunity, with the company estimating annual sales of $122.00 million for this product.

Product Details and Market Potential

Glucagon for Injection USP, 1mg/vial is bioequivalent to Eli Lilly and Company's Glucagon for Injection, 1 mg/vial. The product is indicated for two primary uses:

1. Treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus
2. As a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients

According to IQVIA data, the estimated annual sales for Glucagon for Injection USP, 1mg/vial packaged in an emergency kit in the U.S. market stood at $122.00 million.

Expanding Lupin's U.S. Portfolio

This launch marks another milestone in Lupin's efforts to strengthen its presence in the U.S. pharmaceutical market. The company has been focusing on expanding its portfolio of complex generics and specialty products in key therapeutic areas.

About Lupin Limited

Headquartered in Mumbai, India, Lupin Limited is a global pharmaceutical company 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
• Active pharmaceutical ingredients

Lupin has established a strong position in both the Indian and U.S. markets across multiple therapy areas, including:

• Respiratory
• Cardiovascular
• Anti-diabetic
• Anti-infective
• Gastrointestinal
• Central nervous system
• Women's health

With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin employs over 23,000 professionals. The company is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

This latest product launch underscores Lupin's ongoing commitment to expanding its presence in the U.S. market and addressing critical patient needs in the area of diabetes management and diagnostic procedures.

Lupin Limited , one of India's leading pharmaceutical companies, has announced ambitious growth projections and strategic plans for the coming years, signaling a robust outlook for both its overall operations and its U.S. business.

Strong Growth Projections

The company anticipates strong double-digit growth for both its overall business and its U.S. operations in FY26. This projection comes on the heels of a solid performance in the first quarter of FY26, where Lupin reported a 12% year-over-year increase in sales, reaching ₹61,638.00 million.

EBITDA Margin Guidance

Lupin has set a clear target for its profitability, providing EBITDA margin guidance of 24-25% for FY26. This guidance represents a significant improvement from the 26.6% EBITDA margin reported in Q1 FY26, which itself was a substantial increase from 23.3% in the same quarter of the previous year.

Tax Rate Expectations

The company expects its full-year effective tax rate to be approximately 19% for FY26, providing clarity on its tax obligations for the upcoming fiscal year.

Q1 FY26 Performance Highlights

Lupin's Q1 FY26 results underscore the company's strong momentum:

Geographic Performance

The company's growth was broad-based across various markets:

Key Developments and Future Plans

Lupin has made significant strides in various areas and outlined ambitious plans for the future:

1. Product Launches: Successfully launched Tolvaptan tablets (generic Jynarque®) with sole first-to-file 180-day exclusivity in the U.S. market.

2. Regulatory Compliance: Received Establishment Inspection Report (EIR) for Nagpur Unit-II from the U.S. FDA.

3. Business Development: Entered into out-license partnerships for several products, including Ranibizumab in Latin America and Certolizumab Pegol across multiple markets.

4. U.S. Market Performance: Achieved the highest quarterly sales in the U.S. since Q4 FY17, maintaining its position as the 3rd largest generic company by prescriptions.

5. R&D Focus: Plans to file 15+ products in FY26, with two-thirds in complex generics.

6. Dulera Launch: Expects to respond to the Complete Response Letter (CRL) for Dulera in FY26, with a potential product launch planned for the second half of FY27 or early FY28.

7. Product Pipeline: Aims to introduce over 80 products in India over the next five years.

8. FY27 Outlook: Anticipates at least high single-digit growth and plans to improve margins through cost optimization efforts.

Future Outlook

Lupin's management is focusing on several key areas to drive future growth:

• Expanding its complex generics and biosimilars portfolio
• Enhancing its presence in the U.S. market
• Strengthening its position in the Indian pharmaceutical market
• Improving operational efficiency and cost optimization

With these strategic initiatives and strong financial projections, Lupin appears well-positioned to achieve its ambitious growth targets for FY26 and beyond.