Alembic Pharma Gets USFDA Final Approval for Parkinson's Drug Stalevo Generic

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.