Alembic Pharmaceuticals gets USFDA’s final nod for Dexlansoprazole Delayed-Release Capsules

13 Nov 2025 Evaluate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: (i) Healing of all grades of erosive esophagitis (EE), (ii) Maintenance of healed EE and relief of heartburn, and (iii) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). 

Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg, have an estimated market size of $285 million for twelve months ending September 2025 according to IQVIA. The company has a cumulative total of 229 ANDA approvals (209 final approvals and 20 tentative approvals) from USFDA.

Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.


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