Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cilag AG | Schaffhausen, Switzerland | Makes it and tests it | No problems foundNov 21, 2025 · 8 inspections |
| Janssen Biologics B.V. | Leiden, Netherlands | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections |
| Janssen Sciences Ireland UC | CO Cork, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 12, 2024 · 5 inspections |
| Simtra US LLC | Bloomington, IN, United States | Makes it | Problems found, fixed voluntarilySep 24, 2024 · 12 inspections |
Product details
- Generic drug
- Ustekinumab: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 45 mg per 0.5 mL
- Approval
- BLA BLA125261
- On the market since
- Apr 1, 2025
- Package NDCs
57894-440-0157894-440-03- Official label
- DailyMed (National Library of Medicine), updated Oct 16, 2026
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