Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Where is Nirsevimab made?
1 company sell it under their own name. Their labels name 7 factories in the United States, Italy, South Korea and Canada.
United States 4Italy 1South Korea 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi Vaccines US Inc. Beyfortus100 mg per 1 mL · NDC 49281-575, 49281-574 | AstraZeneca Pharmaceuticals LPMakes the active ingredient and tests it | Frederick, MD, United States | Problems found, fixed voluntarilyJan 2023 |
| Catalent Anagni S.R.L.Makes it and tests it | Anagni (fontana Del Ceraso), Italy | Problems found, fixed voluntarilyFeb 2024 | |
| Patheon Manufacturing Services LLCMakes it and tests it | Greenville, NC, United States | No problems foundSep 2025 | |
| Patheon Manufacturing Services LLCMakes it and tests it | Ridgefield, NJ, United States | Problems found, fixed voluntarilyMar 2024 | |
| Samsung Biologics Co., Ltd.Makes it, makes the active ingredient and tests it | Incheon, South Korea | Problems found, fixed voluntarilySep 2023 | |
| Sanofi Vaccines Canada Ltd.Makes it | North York, Canada | Not inspected on record | |
| Sanofi Vaccines US Inc.Makes it, packages it and labels it | Swiftwater, PA, United States | Problems found, fixed voluntarilyApr 2023 |