Alembic Pharma Gets USFDA Final Approval for Parkinson's Drug Stalevo Generic
New Delhi: Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa and Entacapone Tablets, further strengthening the company's presence in the regulated US generics market.
The approval covers multiple strengths of Carbidopa, Levodopa and Entacapone Tablets, 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.
These tablets are therapeutically equivalent to the reference listed drug (RLD) Stalevo Tablets of Orion Corporation. The product is indicated for the treatment of Parkinson’s disease, with detailed indications available in the approved label.
The company informed the stock exchanges that the approval has been granted by the USFDA for the final version of the ANDA, enabling Alembic to market the product in the United States. The latest approval is in line with Alembic’s strategy to expand its portfolio of complex and combination generic formulations in regulated markets, particularly the US.
With this approval, Alembic Pharmaceuticals Limited has achieved a cumulative total of 234 ANDA approvals from the USFDA, comprising 214 final approvals and 20 tentative approvals. This milestone highlights the company’s consistent focus on research and development, quality manufacturing, and regulatory compliance.
Alembic Pharmaceuticals Limited, founded in 1907, is a vertically integrated research and development-driven pharmaceutical company headquartered in India. The company manufactures and markets generic pharmaceutical products globally and operates state-of-the-art research and manufacturing facilities approved by regulatory authorities of several developed countries, including the USFDA. Alembic is also one of the leaders in branded generics in India, with a strong portfolio supported by a large field force and widespread recognition among healthcare professionals and patients.
