Alembic Pharmaceuticals Limited has achieved a significant milestone in its pharmaceutical journey by receiving final approval from the US Food & Drug Administration (USFDA) for its Dexlansoprazole Delayed-Release Capsules in 30 mg and 60 mg strengths. This development marks a crucial step for the company in expanding its presence in the US pharmaceutical market.

Key Highlights

• Product Approval: Alembic Pharmaceuticals has received USFDA final approval for Dexlansoprazole Delayed-Release Capsules.
• Market Potential: The approved product has an estimated market size of $285 million.
• Therapeutic Use: Dexlansoprazole is a proton pump inhibitor (PPI) used for treating various gastrointestinal conditions.
• Target Age Group: The medication is indicated for patients 12 years of age and older.

Product Details

Dexlansoprazole Delayed-Release Capsules are therapeutically equivalent to Takeda Pharmaceuticals USA, Inc.'s Dexilant Delayed-Release Capsules. The medication is primarily used for:

1. Healing of all grades of erosive esophagitis (EE)
2. Maintenance of healed EE and relief of heartburn
3. Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD)

Market Impact

The approval of Dexlansoprazole Delayed-Release Capsules opens up a significant market opportunity for Alembic Pharmaceuticals. According to IQVIA data, the estimated market size for this product is $285.00 million for the twelve months ending September 2025.

Alembic's ANDA Approvals

This latest approval adds to Alembic's impressive track record with the USFDA:

Company Background

Alembic Pharmaceuticals Limited, established in 1907, is a vertically integrated research and development pharmaceutical company. The company specializes in manufacturing and marketing generic pharmaceutical products globally. With state-of-the-art research and manufacturing facilities approved by regulatory authorities of many developed countries, including the USFDA, Alembic has positioned itself as a leader in branded generics in India.

This latest USFDA approval for Dexlansoprazole Delayed-Release Capsules not only enhances Alembic's product portfolio but also strengthens its position in the competitive US pharmaceutical market. The significant market size of the approved product suggests potential for substantial revenue generation, subject to successful commercialization and market penetration strategies.

Alembic Pharmaceuticals Limited (ISIN: INE901L01018) has reported a strong performance for the second quarter of fiscal year 2026, with significant revenue growth and strategic expansion into the US branded drug market.

Financial Highlights

Alembic Pharmaceuticals delivered impressive financial results for Q2 FY26:

The company's revenue growth was driven by higher volumes and new product launches across various business segments.

Business Segment Performance

• India Branded Business: Grew by 5% to ₹639.00 crores, with strong performance in Gynecology, Ophthalmology, and Animal Health segments.
• US Business: Expanded by 21%, supported by higher volumes despite pricing challenges.
• Rest of World Markets: Recorded a 31% growth, reflecting successful geographic expansion.
• API Business: Grew by 15%, contributing to the overall positive performance.

Strategic Developments

Alembic Pharmaceuticals has made a significant move into the US branded drug market:

• Acquired Utility Therapeutics for $4.00 million upfront, with additional milestone payments.
• Gained access to Pivya, a product for urinary tract infections, marking entry into the US branded segment.
• Plans to launch Pivya in late Q4 FY26, targeting a market with 30 million prescriptions annually.

R&D and Product Pipeline

The company continues to invest in research and development:

• Filed 2 ANDAs and received 6 approvals during the quarter.
• Launched 3 products in the US market.
• Cumulative ANDA filings stand at 269, with 226 approvals including 21 tentative approvals.
• Focused on complex areas such as injectables, peptides, and oral solids.

Management Commentary

Pranav Amin, Managing Director, stated, "Our Q2 performance reflects continued momentum as we strengthen our presence across key markets. We're particularly excited about our entry into the US branded drug market with Pivya, which we believe will be a significant growth driver in the coming years."

Outlook

Alembic Pharmaceuticals aims to improve EBITDA margins to 18-19% levels in the near term, with a goal of reaching 20% in the next couple of years. The company expects to launch 8-10 new products in the US market in the second half of FY26.

While the entry into the US branded drug market may impact near-term profitability, management is confident about the medium to long-term market opportunity.

Investors should note that the company's performance in the rest of world markets may normalize in the second half, given the lower base effect in the previous year's first half.

As Alembic Pharmaceuticals continues to execute its growth strategy and expand its product portfolio, it remains well-positioned to capitalize on opportunities in both domestic and international markets.