Alembic Pharma gets USFDA’s approval for Carbidopa, Levodopa and Entacapone Tablets

06 Feb 2026 Evaluate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbidopa, Levodopa and Entacapone Tablets, 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 (RLD), Stalevo Tablets, 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, of Orion Corporation. Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Refer label for a detailed indication.

Alembic has a cumulative total of 234 ANDA approvals (214 final approvals and 20 tentative approvals) from USFDA. 

Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.


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