Alembic Pharma receives USFDA nod for Dexlansoprazole Delayed-Release Capsules

Alembic Pharmaceuticals announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dexlansoprazole Delayed-Release Capsules.

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 for use in patients 12 years of age and older for the healing of all grades of erosive esophagitis (EE), the maintenance of healed EE and relief of heartburn, as well as the 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 the twelve months ending September 2025, according to IQVIA.

With this approval, Alembic now holds a cumulative total of 229 ANDA approvals (including 209 final approvals and 20 tentative approvals) from the USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.

The companys consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025.

The counter rose 0.53% to currently trade at Rs 922 on the BSE.

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