CD38-directed Cytolytic Antibody, Endoglycosidase
Where is Daratumumab and Hyaluronidase (human Recombinant) made?
1 company sell it under their own name. Their labels name 5 factories in the United States, Switzerland and Denmark.
United States 2Switzerland 2Denmark 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Biotech, Inc. Darzalex Faspro1800 mg per 15 mL / 30000 U per 15 mL · NDC 57894-503 | Catalent Indiana, LLCMakes the active ingredient | Bloomington, IN, United States | Serious problems, FDA actionApr 2026 |
| 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 | |
| Janssen Biotech, Inc.Makes the active ingredient and tests it | Malvern, PA, United States | Problems found, fixed voluntarilyJul 2025 | |
| Lonza AGMakes it and tests it | Visp, Switzerland | Not inspected on record |