The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Stalevo Tablets, manufactured by Orion Corporation. These tablets are indicated for the treatment of Parkinson’s disease.
With this approval, Alembic Pharmaceuticals now has a cumulative total of 234 ANDA approvals from the USFDA, including 214 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets.
On the financial front, the company reported a consolidated net profit of Rs 184.71 crore in Q2 FY26, up 20.40% from Rs 153.41 crore in Q2 FY25. Revenue from operations rose 15.90% year-on-year to Rs 1,910.15 crore in the quarter ended September 2025.
Shares of Alembic Pharmaceuticals declined 2.17% to Rs 792.15 on the BSE.