Alembic Pharmaceuticals has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.05 percent.

The approved product is therapeutically equivalent to the reference listed drug (RLD), Retin-A Cream, 0.05 percent, marketed by Bausch Health US, LLC. Tretinoin cream is indicated for the topical treatment of acne vulgaris, a common skin condition affecting millions of patients worldwide.

According to IQVIA data, Tretinoin Cream USP, 0.05 percent, has an estimated market size of USD 76 million in the United States for the twelve months ending March 2026.

The latest approval further strengthens Alembic Pharmaceuticals’ presence in the US generics market and expands its dermatology portfolio. With this development, the company’s cumulative USFDA approvals have risen to 242 ANDAs, comprising 222 final approvals and 20 tentative approvals.

Headquartered in India, Alembic Pharmaceuticals is a publicly listed pharmaceutical company engaged in the manufacturing and marketing of generic medicines across global markets. The company operates research and manufacturing facilities that comply with international regulatory standards and have been approved by major global agencies, including the USFDA.

The approval underscores Alembic’s continued focus on expanding its product pipeline and strengthening its footprint in regulated markets through the development of high-quality generic formulations.