Alembic Pharmaceuticals Secures USFDA Approval for Dexlansoprazole

Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Dexlansoprazole Delayed-Release Capsules, available in 30 mg and 60 mg dosages. The approval confirms that Alembic’s product is therapeutically equivalent to the reference listed drug, Dexilant Delayed-Release Capsules, manufactured by Takeda Pharmaceuticals USA, Inc.

The approved Dexlansoprazole capsules are classified as a proton pump inhibitor. They are indicated for use in patients aged 12 years and older for the healing of all grades of erosive esophagitis, maintenance of healed erosive esophagitis and relief of heartburn, and treatment of symptomatic non-erosive gastroesophageal reflux disease. The estimated market size for Dexlansoprazole is approximately USD 285 million for the twelve months ending September 2025, according to IQVIA data.

With this approval, Alembic Pharmaceuticals has accumulated a total of 229 ANDA approvals from the USFDA, comprising 209 final approvals and 20 tentative approvals. This milestone further strengthens Alembic’s position in the pharmaceutical market, particularly in the United States.

Alembic Pharmaceuticals Limited is a research and development-focused pharmaceutical company that has been operational since 1907. The company is involved in the manufacturing and marketing of generic pharmaceutical products globally. Alembic’s research and manufacturing facilities are approved by regulatory authorities in several developed countries, including the USFDA. The company is recognized as a leader in branded generics within India.