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
The company reported a 108% rise in profit after tax, driven by strong growth in regulated markets, branded generics, and U.S. expansion initiatives
Global specialty pipeline accelerates growth
On the generics and biosimilars front, the combined business is expected to benefit from Sun’s portfolio of more than 550 approved ANDAs across multiple dosage forms
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