Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10 mg, 17.5 mg, and 25 mg, of Stiefel Laboratories, Inc. (Stiefel). Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Refer label for a detailed indication.

Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg have an estimated market size of USD 21 million for twelve months ending June 2024. Alembic has a cumulative total of 212 ANDA approvals (184 final approvals and 28 tentative approvals) from the US FDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Alembic's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.