Alembic Pharmaceuticals Gains USFDA Approval for Parkinson’s Drug

Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa, and Entacapone Tablets. The approval was granted on 06th February, 2026, and covers multiple dosage strengths including 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product, Stalevo Tablets, manufactured by Orion Corporation. These tablets are indicated for the treatment of Parkinson’s disease. The approval allows Alembic to market these tablets in the United States, expanding its portfolio in the generic pharmaceuticals market.

Alembic Pharmaceuticals has a cumulative total of 234 ANDA approvals from the USFDA, which includes 214 final approvals and 20 tentative approvals. This approval is part of Alembic’s strategy to enhance its presence in the global pharmaceutical market by offering a wide range of generic products.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It has been operational since 1907 and is involved in the manufacturing and marketing of generic pharmaceutical products worldwide. The company is recognized for its state-of-the-art research and manufacturing facilities, which are approved by regulatory authorities in several developed countries, including the USFDA. Alembic is a leader in branded generics in India, with a significant market presence supported by a field force of over 5500 professionals.