Biocon Biologics’ biosimilars manufacturing complex at Biocon Park, Bengaluru, Karnataka, underwent a Pre-License Inspection (PLI) by the U.S. FDA from April 20, 2026 to April 29, 2026.
·
Top Generic
Products Manufactured: Rosuvastatin
Calcium, Atorvastatin Calcium, Everolimus, Sacubitril; Valsartan, Tacrolimus.
· Products Likely Exposed to Shortages (Market Share >25%): None identified based on current market share assessment.
· Revenue Contribution: The inspected facilities collectively generate approximately $44.67 Mn in U.S. sales from generics (ANDA) only, representing around 76.36% of Biocon’s total U.S. generics revenue (excluding biosimilars).