Interleukin-6 Receptor Antagonist
Where is Tocilizumab made?
5 companies sell it under their own name. Their labels name 7 factories in the United States, China, Austria and Italy.
United States 4China 1Austria 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Biogen MA Inc. Tofidence20 mg per 1 mL · NDC 64406-022, 64406-023, 64406-024 | Bio-Thera Solutions, Ltd.Makes it and makes the active ingredient | Guangzhou, China | Not inspected on record |
| Biogen MA Inc.Makes the active ingredient and tests it | Morrisville, NC, United States | No problems foundJun 2018 | |
| Biogen U.S. CorporationMakes it and tests it | Morrisville, NC, United States | Problems found, fixed voluntarilyAug 2022 | |
| Fresenius Kabi USA, LLC Tyenne80 mg per 4 mL, 162 mg per 0.9 mL, 200 mg per 10 mL, 400 mg per 20 mL · NDC 65219-598, 65219-596, 65219-586 +4 | Fresenius Kabi AustriaMakes it | Austria 8055, Austria | Problems found, fixed voluntarilyMar 2024 |
| Merck Serono SpaMakes it | Modugno (loc. frazione Zona Industriale), Italy | Problems found, fixed voluntarilySep 2025 | |
| Genentech, Inc. Actemra, Actemra ACTPen80 mg per 4 mL, 162 mg per 0.9 mL, 200 mg per 10 mL, 400 mg per 20 mL · NDC 50242-138, 50242-143, 50242-136 +2 | Genentech, Inc.Makes the active ingredient and tests it | Oceanside, CA, United States | No problems foundAug 2024 |
| Genentech, Inc.Makes it, tests it, packages it and labels it | Hillsboro, OR, United States | Problems found, fixed voluntarilyApr 2024 | |
| CELLTRION USA, Inc. Avtozma80 mg per 4 mL, 162 mg per 0.9 mL, 200 mg per 10 mL, 400 mg per 20 mL · NDC 72606-045, 72606-043, 72606-044 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Organon LLC Tofidence80 mg per 4 mL, 200 mg per 10 mL, 400 mg per 20 mL · NDC 78206-201, 78206-202, 78206-200 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Aug 10, 2026 · Class I · Fresenius Kabi USA, LLC
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.