Labeler · US market

Swedish Orphan Biovitrum AB (publ)

Swedish Orphan Biovitrum AB (publ) is a US drug labeler with US FDA registrations covering 6 drug concepts (5 currently active) across 17 packages. It is currently the only active US supplier of 4 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes66658

Active drugs5

Registrations14 active / 16

Packages17

Sole supplier of4 drugs

Portfolio6 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Emapalumab-Lzsg injection	rx	7	7	SUPPLYING
Nitisinone capsule	rx	4	4	SUPPLYING
Anakinra injection, solution	rx	1	2	SUPPLYING
Nitisinone suspension	rx	1	1	SUPPLYING
Palifermin injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Palivizumab injection, solution	rx	2	2	DISCONTINUED

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes66658
Filing names1
Drugs (active)5
Drugs (all time)6
US registrations16
Packages17

Recent events

Shortages, recalls, and registration changes across all filing names.

Aug 13, 2025
RESOLVEDShortage resolved: Palivizumab Injection (Swedish Orphan Biovitrum AB)
Aug 13, 2025
SHORTAGEDrug shortage: Palivizumab Injection (Swedish Orphan Biovitrum AB)

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.