Drug Approval | May 15, 2026
Alembic Pharma receives USFDA tentative approval for Darolutamide tablets
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
With over 30 years of pharmaceutical industry experience, Ponnusamy will lead Alembic’s animal health business strategy, market expansion, and operational growth initiatives
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
Enthral.ai’s platform integrates AI-driven capabilities with compliance-first architecture, enabling automated training workflows
The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets
The inspection was carried out between May 26, 2025 and May 31, 2025
Alembic receives EIR from USFDA for facility at Panelav
The India Branded Business delivered a 5% YoY growth, reaching Rs. 599 crore in revenue for the quarter
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug
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