Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | Frederick, MD, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 19, 2023 · 5 inspections |
| Catalent Anagni S.R.L. | Anagni (fontana Del Ceraso), Italy | Makes it and tests it | Problems found, fixed voluntarilyFeb 23, 2024 · 7 inspections |
| Patheon Manufacturing Services LLC | Greenville, NC, United States | Makes it and tests it | No problems foundSep 26, 2025 · 11 inspections |
| Patheon Manufacturing Services LLC | Ridgefield, NJ, United States | Makes it and tests it | Problems found, fixed voluntarilyMar 18, 2024 · 8 inspections |
| Samsung Biologics Co., Ltd. | Incheon, South Korea | Makes it, makes the active ingredient and tests it | Problems found, fixed voluntarilySep 1, 2023 · 3 inspections |
| Sanofi Vaccines Canada Ltd. | North York, Canada | Makes it | Not inspected on record |
| Sanofi Vaccines US Inc. | Swiftwater, PA, United States | Makes it, packages it and labels it | Problems found, fixed voluntarilyApr 22, 2023 · 2 inspections |
| Bushu Pharmaceuticals, Ltd. | Kawagoe, Japan | Tests it | Problems found, fixed voluntarilyAug 3, 2026 · 5 inspections |
| Charles River Laboratories, Inc. | Malvern, PA, United States | Tests it | No problems foundJan 20, 2026 · 6 inspections |
| Packaging Coordinators, LLC | Philadelphia, PA, United States | Packages it and labels it | Problems found, fixed voluntarilyJan 31, 2025 · 6 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it and labels it | No problems foundNov 21, 2025 · 7 inspections |
Product details
- Generic drug
- Nirsevimab: every company that makes it
- Form
- injection, intramuscular
- Strength
- 100 mg per 1 mL
- Approval
- BLA BLA761328
- On the market since
- Jul 18, 2023
- Package NDCs
49281-574-1549281-574-88- Official label
- DailyMed (National Library of Medicine), updated Jul 13, 2026
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