Labeler · US market

Alexion Pharmaceuticals, Inc.

Alexion Pharmaceuticals, Inc. is a US drug labeler with US FDA registrations covering 6 drug concepts (6 currently active) across 11 packages. It is currently the only active US supplier of 6 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes25682

Active drugs6

Registrations11 active / 11

Packages11

Sole supplier of6 drugs

Portfolio6 drugs · US

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

Drug	Type	NDCs	Packages	Status
Asfotase Alfa solution	rx	4	4	SUPPLYING
Ravulizumab solution, concentrate	rx	3	3	SUPPLYING
Sebelipase Alfa injection, solution, concentrate	rx	1	1	SUPPLYING
Danicopan tablet, film coated	rx	1	1	SUPPLYING
Eculizumab injection, solution, concentrate	rx	1	1	SUPPLYING
Danicopan kit	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 codes25682
Filing names1
Drugs (active)6
Drugs (all time)6
US registrations11
Packages11

Recent events

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

Jun 2, 2014
RECALLRecall (Class I): Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals…
Nov 4, 2013
RECALLRecall (Class I): Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Via…

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.