Granules India Files ANDA for Ruxolitinib ER Tablets, Seeks First-to-File Status

Granules India Limited has submitted an Abbreviated New Drug Application (ANDA) for Ruxolitinib Extended-Release Tablets with a Paragraph IV certification. The company believes it is eligible for first-to-file status, which could grant 180 days of generic drug exclusivity in the U.S. if confirmed by the FDA. This strategic move aligns with Granules India's objective to enhance its U.S. product portfolio with higher-value generics. The ANDA is subject to FDA review, and the company will provide further updates as required. This filing represents a significant step in their U.S. market strategy, focusing on technically and commercially attractive opportunities.