Alembic Pharmaceuticals Receives USFDA Approval for Dexlansoprazole Capsules, Expands US Generic Portfolio

Alembic Pharmaceuticals Bolsters US Market Presence with USFDA Nod for Dexlansoprazole Capsules

Alembic Pharmaceuticals Ltd. has achieved a significant milestone, obtaining final approval from the USFDA for its generic version of Dexlansoprazole delayed-release capsules, a key drug for the treatment of gastroesophageal reflux disease (GERD) and related acid disorders. These capsules are a generic equivalent of Takeda Pharmaceuticals’ branded drug, Kapidex.

The approval is part of Alembic’s continuous efforts to enhance its product portfolio in the US, which is a critical market for the company. Dexlansoprazole offers unique dual delayed release action, providing longer acid suppression with once-daily dosing—a convenient option for patients.

This launch reinforces Alembic’s commitment to expanding access to affordable and effective generic medicines globally while capitalizing on growing demand in acid reflux and related therapeutic segments.

With a robust pipeline and increasing ANDA approvals, Alembic continues to strengthen its competitive positioning, aiming to deliver sustained growth in the competitive US pharmaceutical market.

Key Highlights:

USFDA approval received for Dexlansoprazole delayed-release capsules.

Product is generic equivalent of Kapidex, used for GERD and acid-related disorders.

Offers prolonged acid suppression with convenient once-daily dosing.

Enhances Alembic’s gastroenterology portfolio in the US market.

Reflects company’s strategy to grow through regulatory approvals and launches.

Alembic holds over 220 ANDA approvals, expanding its presence globally.

Source: USFDA, Alembic Pharmaceuticals official release, Economic Times (2025)