Alembic Pharma Gets USFDA Approval Paroxetine ER Tablets

Alembic Pharmaceuticals received USFDA final approval for Paroxetine Extended-Release Tablets USP, 12.5 mg on 27th March 2026.
The approved sANDA is therapeutically equivalent to Paxil CR Tablets 12.5 mg, the reference listed drug of Apotex Inc.
With this approval, Alembic's cumulative USFDA ANDA count reaches 235 (216 final + 19 tentative approvals).