Alembic Pharmaceuticals Gains USFDA Approval for Paroxetine Tablets

Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Paroxetine Extended-Release Tablets USP, 12.5 mg. This approval was granted on 27th March 2026.

The approved sANDA confirms that Alembic’s Paroxetine Extended-Release Tablets are therapeutically equivalent to the reference listed drug product, Paxil CR Tablets, 12.5 mg, manufactured by Apotex Inc. The tablets are indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder. Detailed indications are available on the product label.

With this approval, Alembic Pharmaceuticals has achieved a cumulative total of 235 ANDA approvals from the USFDA, which includes 216 final approvals and 19 tentative approvals. This milestone reflects Alembic’s ongoing commitment to expanding its portfolio of generic pharmaceutical products in the US market.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Established in 1907, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products globally. The company is recognized for its state-of-the-art research and manufacturing facilities, which have received approvals from regulatory authorities in several developed countries, including the USFDA. Alembic is a leader in branded generics in India, with a field force of over 5500 professionals.