Suppliers and packages for biologic ingredient: guselkumab

Suppliers and packages for biologic ingredient: guselkumab

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities

Applicant	Tradename	Biologic Ingredient	Dosage	BLA	NDA/ANDA	Supplier	Package Code	Package
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	BLA	Janssen Biotech, Inc.	57894-640-01	1 SYRINGE in 1 CARTON (57894-640-01) / 1 mL in 1 SYRINGE
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	BLA	Janssen Biotech, Inc.	57894-640-04	1 SYRINGE in 1 CARTON (57894-640-04) / 1 mL in 1 SYRINGE
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	BLA	Janssen Biotech, Inc.	57894-640-06	1 SYRINGE in 1 CARTON (57894-640-06) / 1 mL in 1 SYRINGE (57894-640-03)
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	BLA	Janssen Biotech, Inc.	57894-640-11	1 SYRINGE in 1 CARTON (57894-640-11) / 1 mL in 1 SYRINGE
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	BLA	Janssen Biotech, Inc.	57894-640-99	1 SYRINGE in 1 CARTON (57894-640-99) / 1 mL in 1 SYRINGE
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	BLA	Janssen Biotech, Inc.	57894-650-02	1 VIAL, SINGLE-DOSE in 1 CARTON (57894-650-02) / 20 mL in 1 VIAL, SINGLE-DOSE (57894-650-01)