Tag: Lupin
GENERAL Lupin Secures USFDA Approval For Ranibizumab Biosimilar Ranluspec

Global pharmaceutical major Lupin has received approval from the US Food and Drug Administration (FDA) for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis, marking a significant milestone in the company’s expanding biosimilars portfolio. The approval makes Ranluspec the only interchangeable ranibizumab biosimilar in the United States available in both vial and pre-filled syringe (PFS) presentations. […]

CW Bureau · Jun 5, 2026
GENERAL Lupin Gets Clean Inspection Report From US FDA For Ankleshwar Plant

Pharma major Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Ankleshwar manufacturing facility in Gujarat following the closure of a product-specific pre-approval inspection conducted between March 2 and March 7, 2026. The receipt of the EIR marks the successful […]

CW Bureau · May 28, 2026