NDC 57894-071

Simponi 100 mg per 1 mL injection, solution

On the label: Janssen Biotech, Inc..

Netherlands: 1Ireland: 1United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Janssen Biologics B.V.Leiden, NetherlandsMakes the active ingredient and tests it Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections
Janssen Sciences Ireland UCCO Cork, IrelandMakes the active ingredient and tests it Problems found, fixed voluntarilyJan 12, 2024 · 5 inspections
Simtra US LLCBloomington, IN, United StatesMakes it and tests it Problems found, fixed voluntarilySep 24, 2024 · 12 inspections
AndersonBrecon Inc.Rockford, IL, United StatesPackages it and labels it No problems foundAug 19, 2026 · 11 inspections
Cilag AGSchaffhausen, SwitzerlandTests it, packages it and labels it No problems foundNov 21, 2025 · 8 inspections

Product details

Generic drug
Golimumab: every company that makes it
Form
injection, solution, subcutaneous
Strength
100 mg per 1 mL
Approval
BLA BLA125289
On the market since
May 15, 2013
Package NDCs
57894-071-01 57894-071-02 57894-071-89 57894-071-90
Official label
DailyMed (National Library of Medicine), updated Nov 2, 2026

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