Is Alexion Pharmaceuticals, Inc. FDA approved?

Alexion Pharmaceuticals, Inc. holds 3 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Alexion Pharmaceuticals, Inc.'s drugs manufactured?

At registered sites in Ireland, the United States. The FDA register lists Athlone; Dublin; Bogart, GA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Alexion Pharmaceuticals, Inc. make?

10 products are listed under Alexion Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as solution; solution, concentrate; injection, solution, concentrate. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Alexion Pharmaceuticals, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 3
Active NDC listings: 10
Labeller names: 2
Live patents: 4
Exclusivities: 1
Countries: 2
Base: Ireland

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture2Labelling1Finished drug manufacture2Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Alexion Pharma International Operations LimitedRegistrant: Alexion Pharmaceuticals, Inc.	Monksland Industrial Estate, Athlone, N37 DH79, Ireland (IRL)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3011532960986018601
Alexion Pharma International Operations LimitedRegistrant: Alexion Pharmaceuticals, Inc.	College Business and Technology Park, Dublin, D15 R925, Ireland (IRL)	Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging	3012889718985573659
Alexion Pharmaceuticals Inc.Registrant: Alexion Pharmaceuticals, Inc.	1074 Gateway East Pkwy, Bogart, Georgia (GA) 30622-2007, United States (USA)	Analytical testing, Finished drug manufacture	3011263308079580471

Catalogue

Drug listings by form and route

10 active NDC listings: 10 human prescription drug. By marketing category: BLA 8, NDA 2.

Dosage form	NDCs
solution	4
solution, concentrate	3
injection, solution, concentrate	1
kit	1
tablet, film coated	1

Route	NDCs
intravenous	4
subcutaneous	4
oral	1

Labeller name on the listing	NDCs
alexion pharmaceuticals inc.	6
alexion pharmaceuticals, inc.	4

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
9796741	VOYDEYAdanicopan	substance	Feb 2035
12076319	VOYDEYAdanicopan	use	Aug 2038

Product	Exclusivity	Until
VOYDEYADANICOPAN	ODE-476 Orphan drug	Mar 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
SOLIRIS	ECULIZUMAB	injection, solution, concentrate, intravenous	25682-001BLA
STRENSIQ	ASFOTASE ALFA	solution, subcutaneous	25682-010BLA
STRENSIQ	ASFOTASE ALFA	solution, subcutaneous	25682-013BLA
STRENSIQ	ASFOTASE ALFA	solution, subcutaneous	25682-016BLA
STRENSIQ	ASFOTASE ALFA	solution, subcutaneous	25682-019BLA
Ultomiris	ravulizumab	solution, concentrate, intravenous	25682-022BLA
Ultomiris	ravulizumab	solution, concentrate, intravenous	25682-025BLA
Ultomiris	ravulizumab	solution, concentrate, intravenous	25682-028BLA
Voydeya	Danicopan	tablet, film coated, oral	25682-043NDA
Voydeya	Danicopan	kit	25682-046NDA

Neighbours

Registered in the same town

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Dublin, IRL
Astellas Pharma US, Inc.DUBLIN, IRL
Allergan, Inc.Dublin, IRL
Almac Pharma Services (Ireland) LimitedAthlone, IRL
Takeda Pharmaceuticals U.S.A., Inc.Dublin, IRL
West Pharmaceutical Services, Inc.Dublin, IRL
Jazz Pharmaceuticals Operations UK LimitedAthlone, IRL
LEO Pharma A/SDublin, IRL
PPD Development, L.P.Athlone, IRL
LIEBEL-FLARSHEIM COMPANY LLC.Dublin, IRL
Clarochem Ireland LimitedDublin, IRL
HELSINN BIREX PHARMACEUTICALS LIMITEDDublin, IRL

Compare

Comparable companies in Ireland

Jazz Pharmaceuticals Operations UK Limited3 sites · 9 NDC
LEO Pharma A/S3 sites · 9 NDC
IPSEN MANUFACTURING IRELAND LIMITED2 sites · 17 NDC
SK BIOTEK2 sites · 10 NDC
LIEBEL-FLARSHEIM COMPANY LLC.2 sites · 7 NDC
Eurofins BioPharma Product Testing India Private Limited4 sites · 0 NDC
Q1 Scientific Ltd2 sites · 0 NDC
Amneal Ireland Limited1 site · 513 NDC
Novo Nordisk Production Ireland Limited1 site · 5 NDC
TOPCHEM PHARMACEUTICALS LIMITED1 site · 5 NDC

Enquiry

Common questions

Is Alexion Pharmaceuticals, Inc. FDA approved?: Alexion Pharmaceuticals, Inc. holds 3 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Alexion Pharmaceuticals, Inc.'s drugs manufactured?: At registered sites in Ireland, the United States. The FDA register lists Athlone; Dublin; Bogart, GA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Alexion Pharmaceuticals, Inc. make?: 10 products are listed under Alexion Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as solution; solution, concentrate; injection, solution, concentrate. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.