Lupin Bioresearch Center receives zero observations from USFDA
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
The presentation will provide qualitative insights into its safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with solid tumors
Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk
The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India
Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A
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