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 Tretinoin Cream USP, 0.05%. The approval was announced via a press release dated 12th June, 2026.
Product Information
The approved product is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05%, which is marketed by Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
Market Context
The product has an estimated market size of US$ 76 million for the twelve months ending March 2026, according to IQVIA data.
Company's Approval Track Record
With this approval, Alembic Pharmaceuticals now has a cumulative total of 242 ANDA approvals from the USFDA, consisting of 222 final approvals and 20 tentative approvals.
Company Background
Alembic Pharmaceuticals Limited is described as a vertically integrated research and development pharmaceutical company that has been operating since 1907. The company manufactures and markets generic pharmaceutical products worldwide and is a leader in branded generics in India. Its state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. The company markets its brands through a field force of over 5500 representatives.