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Results For "Nilesh-Gupta"

67 News Found

Lupin secures U.S. FDA approval for interchangeable biosimilar Ranibizumab
Drug Approval | June 06, 2026

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


Lupin’s Ankleshwar facility receives EIR from U.S. FDA
Drug Approval | May 28, 2026

Lupin’s Ankleshwar facility receives EIR from U.S. FDA

The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026


Lupin Q4 FY26 PBT jumps 115% to Rs 19,280 million
News | May 08, 2026

Lupin Q4 FY26 PBT jumps 115% to Rs 19,280 million

U.S. business drives strong growth as Lupin reports 57% rise in Q4 U.S. sales and 43% increase in gross profit


Zydus, Lupin join forces to expand access to semaglutide in India
News | March 18, 2026

Zydus, Lupin join forces to expand access to semaglutide in India

The deal also includes upfront licensing fees and milestone-based payments from Lupin to Zydus


Lupin receives EIR from FDA for its Goa facility
Drug Approval | February 28, 2026

Lupin receives EIR from FDA for its Goa facility

The EIR was issued following an inspection of the facility from November 10 to November 21, 2025


Lupin and Gan & Lee enter exclusive licensing deal for novel GLP-1 receptor agonist
News | December 29, 2025

Lupin and Gan & Lee enter exclusive licensing deal for novel GLP-1 receptor agonist

Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals


Lupin receives EIR from USFDA for Nagpur injectable facility
Drug Approval | December 17, 2025

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025


Lupin receives FDA approval for biosimilar Armlupeg
Biotech | December 01, 2025

Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs


Lupin receives EIR from FDA for its Aurangabad facility
News | November 13, 2025

Lupin receives EIR from FDA for its Aurangabad facility

The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.