CD38-directed Cytolytic Antibody
Where is Daratumumab made?
1 company sell it under their own name. Their labels name 7 factories in the United States, Switzerland, Denmark, South Korea and Germany.
United States 2Switzerland 2Denmark 1South Korea 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Biotech, Inc. Darzalex, Darzalex IV100 mg per 5 mL · NDC 57894-502, 57894-505 | Biogen MA Inc.Makes the active ingredient | Morrisville, NC, United States | No problems foundJun 2018 |
| Cilag AGMakes it, tests it, packages it and labels it | Schaffhausen, Switzerland | No problems foundNov 2025 | |
| FUJIFILM Diosynth Biotechnologies Denmark ApSMakes the active ingredient | Hillerod, Denmark | Problems found, fixed voluntarilyJun 2023 | |
| Lonza AGMakes it and tests it | Visp, Switzerland | Not inspected on record | |
| Samsung Biologics Co., Ltd.Makes the active ingredient and tests it | Incheon, South Korea | Problems found, fixed voluntarilySep 2023 | |
| Simtra US LLCMakes it, packages it and labels it | Bloomington, IN, United States | Problems found, fixed voluntarilySep 2024 | |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Makes it and tests it | Ravensburg, Germany | Problems found, fixed voluntarilyJul 2023 |