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
The company witnesses strong growth across its India, Africa, and emerging markets businesses, while securing regulatory approval for the first AB-rated gVentolin in the U.S. market
The certification follows an inspection conducted by the Malta Medicines Authority between January 29, 2026, and February 3, 2026
Global specialty pipeline accelerates growth
Net income more than doubled to 2.763 billion euros, while core earnings per share climbed 12.9 percent to 2.71 euros
Shilpa will deliver end-to-end services including CMC development, process scale-up, GMP clinical supply, and commercial manufacturing support
The company’s shares of confidence were underlined by an upgraded 2026 outlook, with Merck now expecting annual net sales of up to €21.4 billion and EBITDA pre of as much as €6.1 billion
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