ANDA -- 219115 -- Chemistry, Manufacturing, and Controls (CMC) Review (Dexlansoprazole Delayed-Release Capsules)

This release contains the FDA's Chemistry, Manufacturing, and Controls (CMC) Review for ANDA 219115, covering Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg, submitted by Alembic Pharmaceuticals Limited.

Documents Delivered

• Chemistry, Manufacturing, and Controls (CMC) Review
• 44 pages of released records

Portions of the records were redacted pursuant to FOIA Exemptions (b)(4) and (b)(6).

Application: ANDA 219115
Product: Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg
Sponsor: Alembic Pharmaceuticals Limited
Approval Date: November 12, 2025
Reference Product: Dexilant® (Dexlansoprazole)
Document Type: FDA Bioequivalence Review
Pages: 165
Agency: U.S. Food and Drug Administration (FDA)