Alembic Pharma bags USFDA nod for erosive esophagitis drug Dexlansoprazole Delayed Release
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-11-13 08:01 GMT | Update On 2025-11-13 08:01 GMT
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Vadodara: Pharma firm Alembic Pharmaceuticals Limited has announced that the company 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
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 US$ 285 million for twelve months ending September 2025 according to IQVIA.
Alembic has a cumulative total of 229 ANDA approvals (209 final approvals and 20 tentative approvals) from USFDA.
In April, Alembic received final approval from the USFDA for its ANDA Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial).
Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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