Emergent BioSolutions announced FDA approval for raxibacumab manufacturing at its Winnipeg, Canada site.
The approval enhances Emergent's manufacturing capabilities for inhalational anthrax treatment.
This regulatory milestone supports Emergent's transformation strategy for sustainable growth.
FDA Approval
U.S. FDA approved Emergent's sBLA for raxibacumab manufacturing in Winnipeg, Canada.
Transformation Strategy
The approval aligns with Emergent's multi-year transformation plan focusing on manufacturing consolidation.
Facility Expertise
Emergent's Winnipeg facility with 45 years of experience specializes in therapeutic development and manufacturing.
Indication and Safety
Raxibacumab is indicated for inhalational anthrax treatment and prophylaxis with safety information provided.
- The FDA approval marks a significant step in Emergent's strategic plan for a customer-focused manufacturing network.
- Consolidation of operations in Winnipeg and Lansing reflects efforts towards long-term sustainable growth.
Emergent BioSolutions' FDA approval for raxibacumab manufacturing signifies progress in their transformation strategy and commitment to health protection.