Advent acquired Zentiva from Sanofi in 2018 and transformed the company into a highly successful standalone business
The approval is expected to support the company’s presence in regulated international markets and further strengthen its position as a reliable pharma manufacturing partner
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
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months
At the institute's 42nd convocation ceremony, Union Minister described its eight-institution MoU initiative as a unique collaborative effort that brings together premier national institutions to create a synergistic research ecosystem
The product is bioequivalent and therapeutically equivalent to the reference listed drug by Fresenius Kabi USA, LLC.
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 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
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