Lupin wins FDA nod for generic colonoscopy prep drug with first-to-file exclusivity
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
Ex-US revenue rose sharply by 21% YoY to Rs. 2, 240.4 crore ($254 million); Operational PAT grew 50.3% YoY to Rs. 518.1 crore
The 38% adjusted EBITDA margin of base business has been supported by robust growth in the CDMO segment
Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market
The company witnesses strong growth across its India, Africa, and emerging markets businesses, while securing regulatory approval for the first AB-rated gVentolin in the U.S. market
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 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
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
OneSource is the contract development and manufacturing organization (CDMO) partner for this product
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