Alembic Pharmaceuticals gets USFDA approval for Dexlansoprazole Capsules

Alembic Pharmaceuticals Limited announced on November 13, 2025, that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg. These capsules are therapeutically equivalent to Dexilant Delayed-Release Capsules. The market size for these capsules is estimated at $285 million for the twelve months ending September 2025, according to IQVIA.

This marks Alembic's 229th ANDA approval from the USFDA, comprising 209 final approvals and 20 tentative approvals. Dexlansoprazole delayed-release capsules are proton pump inhibitors indicated for patients 12 years and older for healing erosive esophagitis, maintaining healed EE, relieving heartburn, and treating symptomatic non-erosive gastroesophageal reflux disease (GERD).