Alembic Pharmaceuticals Limited has announced a major regulatory milestone after securing final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa and Entacapone Tablets. The approval covers multiple 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 formulation is therapeutically equivalent to the reference listed drug Stalevo Tablets, originally developed by Orion Corporation. These tablets are widely prescribed for the treatment of Parkinson’s disease, a chronic and progressive neurological disorder that affects movement and coordination. The approval allows Alembic to market a cost-effective generic version in the US market, subject to standard regulatory conditions.
This development further strengthens Alembic’s presence in the highly regulated US generics space. With this latest clearance, the company’s cumulative USFDA approvals have reached 234 ANDAs, comprising 214 final approvals and 20 tentative approvals. The expanding approval base reflects Alembic’s consistent focus on complex and differentiated products across therapeutic segments.
