Labeler · US market

Actelion Pharmaceuticals US, Inc.

Actelion Pharmaceuticals US, Inc. is a US drug labeler with US FDA registrations covering 10 drug concepts (10 currently active) across 28 packages. It is currently the only active US supplier of 3 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes66215

Active drugs10

Registrations21 active / 21

Packages28

Sole supplier of3 drugs

Portfolio10 drugs · US

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

Drug	Type	NDCs	Packages	Status
Selexipag tablet, coated	rx	8	9	SUPPLYING
Macitentan And Tadalafil tablet, film coated	rx	2	5	SUPPLYING
Bosentan tablet, film coated	rx	2	4	SUPPLYING
Epoprostenol injection, powder, lyophilized, for solution	rx	2	2	SUPPLYING
Selexipag tablet, film coated	rx	2	2	SUPPLYING
Macitentan tablet, film coated	rx	1	2	SUPPLYING
Miglustat capsule	rx	1	1	SUPPLYING
Selexipag kit	rx	1	1	SUPPLYING
Bosentan tablet, for suspension	rx	1	1	SUPPLYING
Selexipag injection, powder, for solution	rx	1	1	SUPPLYING

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 codes66215
Filing names1
Drugs (active)10
Drugs (all time)10
US registrations21
Packages28

Recent events

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

Jan 16, 2013
RECALLRecall (Class III): Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actel…

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.