Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP, 0.025 percent, indicated for the treatment of acne vulgaris.

The approved product is deemed therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 percent, marketed by Bausch Health US, LLC.  According to IQVIA, Tretinoin cream USP has an estimated market size of USD 94 million for 12 months, ending June 2025.

With this approval, Alembic now has a cumulative total of 224 ANDA approvals, comprising 202 final approvals and 22 tentative approvals.

In July, the company received the USFDA approval for Carbamazepine Extended Release Tablets USP, 100 mg, 200 mg, and 400 mg, which are therapeutically equivalent to Novartis’ Tegretol-XR Extended Release Tablets in the same strengths.

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant and for the management of pain associated with true trigeminal neuralgia. According to IQVIA, the product has an estimated market size of USD 71 million for the 12 months ending March 2025.

Headquartered in Vadodara, Gujarat, India, Alembic Pharmaceuticals is a publicly listed company engaged in the global manufacture and marketing of generic pharmaceuticals. Its research and manufacturing facilities are accredited by regulatory authorities of many developed countries, including the USFDA.