Alembic Pharmaceuticals Secures USFDA Approval for Dexlansoprazole Capsules

Alembic Pharmaceuticals has received final USFDA approval for Dexlansoprazole Delayed-Release Capsules in 30 mg and 60 mg strengths, marking the company’s 209th final USFDA approval and 229th ANDA approval. The product is equivalent to Takeda’s Dexilant and is indicated for patients 12 years and older to treat various gastrointestinal conditions.

Significant Market Opportunity

The approval opens access to a $285 million US market, providing Alembic with a strong commercial opportunity in the gastrointestinal segment. This milestone reinforces Alembic’s ongoing commitment to expanding its presence and portfolio in the highly regulated US pharmaceutical market.

Therapeutic Impact

Dexlansoprazole is a proton pump inhibitor (PPI) that helps manage acid-related gastrointestinal disorders, improving treatment options for adolescents and adults. The USFDA approval enhances patient access to a trusted generic alternative while strengthening Alembic’s position in the global PPI market.