Interleukin-12 Antagonist, Interleukin-23 Antagonist
Where is Ustekinumab made?
11 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 5 factories in India, Switzerland, the Netherlands, Ireland and the United States.
India 1Switzerland 1Netherlands 1Ireland 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Biotech, Inc. Stelara45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 57894-054, 57894-444, 57894-060 +3 | Cilag AGMakes it and tests it | Schaffhausen, Switzerland | No problems foundNov 2025 |
| Janssen Biologics B.V.Makes the active ingredient and tests it | Leiden, Netherlands | Problems found, fixed voluntarilyJun 2023 | |
| Janssen Sciences Ireland UCMakes the active ingredient and tests it | CO Cork, Ireland | Problems found, fixed voluntarilyJan 2024 | |
| Simtra US LLCMakes it | Bloomington, IN, United States | Problems found, fixed voluntarilySep 2024 | |
| Biocon Biologics Inc. Yesintek45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 83257-026, 83257-024, 83257-023 +1 | Biocon Biologics LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyJul 2024 |
| Accord BioPharma Inc. Imuldosa45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 69448-019, 69448-017, 69448-018 | The label doesn't name the factory. Plants this company names for other drugs | ||
| CELLTRION USA, Inc. Steqeyma45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 72606-029, 72606-027, 72606-060 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cordavis Limited Pyzchiva45 mg per 0.5 mL, 90 mg per 1 mL · NDC 83457-651, 83457-652 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fresenius Kabi USA, LLC Otulfi, Ustekinumab-Aauz45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 65219-828, 65219-862, 65219-824 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc. Starjemza45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 0143-9171, 0143-9168, 0143-9169 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nuvaila Limited Wezlana45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 84612-066, 84612-076, 84612-055 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Quallent Pharmaceuticals Health LLC Ustekinumab-Ttwe45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 82009-163, 82009-160, 82009-161 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Pyzchiva45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 61314-654, 61314-651, 61314-652 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc. Selarsdi, Ustekinumab-aekn45 mg per 0.5 mL, 90 mg per 1 mL, 130 mg per 26 mL · NDC 51759-708, 51759-505, 51759-709 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ustekinumab in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-7769 - Teva Pharmaceuticals USA, Inc.:
51759-413,51759-607,51759-414
Recalls
- Jun 10, 2026 · Class II · Accord Biopharma Inc
Lack of assurance of Sterility:
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.