Prescription drug
Where is Nipocalimab made?
1 company sell it under their own name. Their labels name 6 factories in Germany, China, the United States and Ireland.
Germany 2China 2United States 1Ireland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Biotech, Inc. Imaavy185 mg per 1 mL · NDC 57894-801, 57894-800 | Janssen Biotech, Inc.Makes the active ingredient | Malvern, PA, United States | Problems found, fixed voluntarilyJul 2025 |
| Janssen Sciences Ireland UCMakes the active ingredient and tests it | CO Cork, Ireland | Problems found, fixed voluntarilyJan 2024 | |
| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse)Makes it and tests it | Langenargen, Germany | Problems found, fixed voluntarilyMar 2024 | |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Makes it, tests it and packages it | Ravensburg, Germany | Problems found, fixed voluntarilyJul 2023 | |
| WuXi Biologics (Shanghai) Co., Ltd.Makes the active ingredient | Shanghai, China | Not inspected on record | |
| WuXi Biologics Co., Ltd.Makes the active ingredient and tests it | Wuxi, China | Problems found, fixed voluntarilyJul 2026 |
Recalls
- Sep 23, 2026 · Class II · J&j Innovative Medicine
Presence of particulate matter.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.