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.

Lupin Limited , a global pharmaceutical leader, has achieved a significant milestone in its manufacturing capabilities. The company announced that its Active Pharmaceutical Ingredient (API) facility in Dabhasa, Gujarat, has received Good Manufacturing Practice (GMP) certification from the Therapeutic Goods Administration (TGA) of Australia.

Key Highlights

• Lupin's wholly-owned subsidiary, Lupin Manufacturing Solutions Limited (LMS), operates the Dabhasa API facility.
• The TGA, Australia's medicines and medical devices regulator, granted the GMP certification after a thorough inspection.
• This certification underscores Lupin's commitment to maintaining high-quality manufacturing standards across its facilities.

Strategic Importance

The GMP certification from TGA Australia for the Dabhasa API facility is a testament to Lupin's dedication to quality and compliance in pharmaceutical manufacturing. This achievement is expected to strengthen Lupin's position in the global pharmaceutical market, particularly in Australia and other regions that recognize TGA certifications.

Dr. Abdelaziz Toumi, Chief Executive Officer of Lupin Manufacturing Solutions, expressed his satisfaction with the certification, stating, "We are pleased to have received the GMP certification from TGA for our Dabhasa facility. This reflects the high standard of our manufacturing practices and expertise of our team at Dabhasa."

Expanding Global Footprint

The certification aligns with Lupin's strategy to expand its global presence. Dr. Toumi emphasized the company's focus on quality, compliance, and operational integrity, adding, "As we continue to expand our global footprint, we remain focused on quality, compliance, and the highest standards of operational integrity, setting new benchmarks in the CDMO space."

About Lupin Manufacturing Solutions

Lupin Manufacturing Solutions (LMS) is a wholly-owned subsidiary of Lupin Limited, specializing in manufacturing and supplying high-quality, cost-effective Active Pharmaceutical Ingredients (APIs). LMS positions itself as the "Partner of Choice" in the Contract Development and Manufacturing Operations (CDMO) space for drug substances.

Lupin's Global Presence

Lupin Limited, headquartered in Mumbai, India, has a strong presence in over 100 markets worldwide. The company is known for its pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and APIs. With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin employs over 23,000 professionals dedicated to improving patient health outcomes.

This latest certification for the Dabhasa API facility reinforces Lupin's reputation as a quality-focused pharmaceutical manufacturer and is expected to contribute to its ongoing growth and expansion in the global pharmaceutical market.