NDC 57894-522
Rybrevant Faspro 3520 mg per 22 mL / 44000 mg per 22 mL injection
On the label: Janssen Biotech, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Avid Bioservices Inc. | Tustin, CA, United States | Makes the active ingredient | No problems foundMay 29, 2025 · 7 inspections |
| Cilag AG | Schaffhausen, Switzerland | Makes it, tests it, packages it and labels it | No problems foundNov 21, 2025 · 8 inspections |
| Janssen Biotech, Inc. | Malvern, PA, United States | Makes it | 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 |
| Samsung Biologics Co., Ltd. | Incheon, South Korea | Makes the active ingredient and tests it | Problems found, fixed voluntarilySep 1, 2023 · 3 inspections |
| Bioreliance Corporation | Rockville, MD, United States | Tests it | Problems found, fixed voluntarilyJan 29, 2026 · 7 inspections |
| Janssen Biologics B.V. | Leiden, Netherlands | Tests it | Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections |
Product details
- Generic drug
- Amivantamab and Hyaluronidase (human Recombinant): every company that makes it
- Form
- injection, subcutaneous
- Strength
- 3520 mg per 22 mL / 44000 mg per 22 mL
- Approval
- BLA BLA761433
- On the market since
- Feb 13, 2026
- Package NDCs
57894-522-01- Official label
- DailyMed (National Library of Medicine), updated Oct 28, 2026
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