Company on the label
CELLTRION USA, Inc.
9 prescription drugs on current FDA listings. Its labels name 11 plants.
Plants named on its labels
| Plant | Where | Role | Last FDA inspection |
|---|---|---|---|
| Patheon Italia S.p.A. | Monza, Italy | Makes it and tests it | Problems found, fixed voluntarilyMay 2023 |
| Patheon Italia S.p.A | Ferentino, Italy | Makes it and tests it | Problems found, fixed voluntarilyFeb 2022 |
| Bioreliance Ltd. | Glasgow Lanarkshire, United Kingdom | Makes it and tests it | Problems found, fixed voluntarilyMay 2026 |
| CELLTRION Inc | Incheon, South Korea | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMay 2024 |
| Samsung Biologics Co., Ltd. | Incheon, South Korea | Tests it | Problems found, fixed voluntarilySep 2023 |
| Advanced Therapies, LLC | Philadelphia, PA, United States | Tests it | No problems foundFeb 2025 |
| Sterigenics Belgium (Petit Rechain) SRL | Verviers, Belgium | Sterilizes it | Problems found, fixed voluntarilyJun 2023 |
| Bioreliance Ltd. | Penicuik, United Kingdom | Tests it | No problems foundSep 2016 |
| Steripack Medical Poland SP Z O O | Leg, Poland | Tests it and packages it | Not inspected on record |
| Celltrion Pharm, Inc | Cheongju, South Korea | Packages it | Problems found, fixed voluntarilyJul 2024 |
| Sterigenics Germany GMBH | Wiesbaden, Germany | Tests it | Not inspected on record |
Drugs
- Adalimumab and Isopropyl Alcohol 72606-063, 72606-024, 72606-041 +6
- Aflibercept 72606-026
- Bevacizumab 72606-011, 72606-012
- Denosumab 72606-038, 72606-059, 72606-037 +1
- Infliximab 72606-047
- Infliximab and Isopropyl Alcohol 72606-025
- Omalizumab 72606-036, 72606-054, 72606-035
- Tocilizumab 72606-045, 72606-043, 72606-044 +1
- Ustekinumab 72606-029, 72606-027, 72606-060 +1