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
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.
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
the inspection conducted from January 27 to January 31, 2025
Revenue up 11% to Rs 5,768 crore as compared to Rs 5,197 crore
The inspection was carried out from January 28 to February 1, 2025
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