India Pharma Outlook Team | Thursday, 13 November 2025
The US Food and Drug Administration (USFDA) has finally approved Alembic Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Dexlansoprazole Delayed-Release Capsules.The authorized ANDA is therapeutically comparable to Takeda Pharmaceuticals USA, Inc.'s (Takeda) reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg.Proton pump inhibitors (PPIs) such as dexlansoprazole delayed-release capsules are recommended for use in patients 12 years of age and older to treat symptomatic non-erosive gastroesophageal reflux disease (GERD), heal all grades of erosive esophagitis (EE), maintain healed EE, and relieve heartburn.
Alembic Pharmaceuticals has received approval for its Dexlansoprazole Delayed-Release Capsules (30 mg and 60 mg), a product that represents an estimated market opportunity of around $285 million for the twelve months ending September 2025, as per IQVIA data.
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With this new approval, Alembic’s total tally of Abbreviated New Drug Application (ANDA) approvals from the USFDA has risen to 229, comprising 209 final approvals and 20 tentative ones.Alembic Pharmaceuticals, a fully integrated research-driven company, develops, manufactures, and distributes generic medicines across global markets. Its production and R&D facilities are certified by regulatory agencies from several developed countries, including the USFDA.For the quarter ending 30 September 2025 (Q2 FY26), the company reported a 20.4% year-on-year increase in consolidated net profit to ?184.71 crore, up from ?153.41 crore in the same period last year. Revenue from operations rose by 15.9% year-on-year to ?1,910.15 crore during the same quarter.
