Lupin secures U.S. FDA approval for interchangeable biosimilar Ranibizumab
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026
U.S. business drives strong growth as Lupin reports 57% rise in Q4 U.S. sales and 43% increase in gross profit
The deal also includes upfront licensing fees and milestone-based payments from Lupin to Zydus
The EIR was issued following an inspection of the facility from November 10 to November 21, 2025
Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs
The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.
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