Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million
Collaboration combines Lupin’s inhaler manufacturing capabilities with ERN’s strong commercial presence to expand access to respiratory care
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai, Inc.
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
First-in-human study of investigational SOS1 inhibitor shows encouraging safety profile and early anti-tumor activity in patients with metastatic solid tumors
The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026
The approval has been secured in partnership with Yabao Pharmaceuticals, a major player in China’s paediatric medicine segment
The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
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