Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biogen MA Inc. | Morrisville, NC, United States | Makes the active ingredient | No problems foundJun 13, 2018 · 9 inspections |
| Cilag AG | Schaffhausen, Switzerland | Makes it, tests it and packages it | No problems foundNov 21, 2025 · 8 inspections |
| Janssen Biotech, Inc. | Malvern, PA, United States | Makes the active ingredient | Problems found, fixed voluntarilyJul 29, 2025 · 13 inspections |
| Janssen Sciences Ireland UC | CO Cork, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 12, 2024 · 5 inspections |
| Janssen Biologics B.V. | Leiden, Netherlands | Tests it | Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections |
Product details
- Generic drug
- Guselkumab: every company that makes it
- Form
- injection, intravenous
- Strength
- 200 mg per 20 mL
- Approval
- BLA BLA761061
- On the market since
- Sep 11, 2024
- Package NDCs
57894-650-0157894-650-02- Official label
- DailyMed (National Library of Medicine), updated Oct 20, 2026
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