Date: 26th June, 2026
Regulatory Approval Details
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapsone Gel, 5%. The approved product is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, manufactured by Almirall, LLC.
Product Information
Dapsone Gel is indicated for the topical treatment of acne vulgaris. The company notes that users should refer to the product label for detailed indication information.
ANDA Approval Portfolio
With this approval, Alembic Pharmaceuticals now has a cumulative total of 244 ANDA approvals from USFDA, consisting of:
- 224 final approvals
- 20 tentative approvals
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been operating since 1907. The company manufactures and markets generic pharmaceutical products worldwide and maintains state-of-the-art research and manufacturing facilities approved by regulatory authorities including USFDA. In India, Alembic is one of the leaders in branded generics, marketing its products through a field force of over 5,500 representatives.