Interleukin-23 Antagonist

Where is Guselkumab made?

1 company sell it under their own name. Their labels name 4 factories in the United States, Switzerland and Ireland.

United States 2Switzerland 1Ireland 1
United States: 2Switzerland: 1Ireland: 1

Companies and their factories

Company on the labelFactoryWhereLast FDA inspection
Janssen Biotech, Inc. Tremfya100 mg per 1 mL, 200 mg per 2 mL, 200 mg per 20 mL · NDC 57894-640, 57894-651, 57894-650 Biogen MA Inc.Makes the active ingredient Morrisville, NC, United StatesNo problems foundJun 2018
Cilag AGMakes it, tests it, packages it and labels it Schaffhausen, SwitzerlandNo problems foundNov 2025
Janssen Biotech, Inc.Makes the active ingredient Malvern, PA, United StatesProblems found, fixed voluntarilyJul 2025
Janssen Sciences Ireland UCMakes the active ingredient and tests it CO Cork, IrelandProblems found, fixed voluntarilyJan 2024

Recalls

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.