Is Novo Nordisk Production Ireland Limited FDA approved?

Novo Nordisk Production Ireland Limited holds 1 FDA-registered establishment in Ireland. 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 Novo Nordisk Production Ireland Limited's drugs manufactured?

The FDA register lists ATHLONE. Registered operations: analytical testing, finished drug manufacture.

What drugs does Novo Nordisk Production Ireland Limited make?

5 products are listed under Novo Nordisk Production Ireland Limited in the openFDA NDC Directory, most often as capsule; capsule, delayed release; powder, for suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Novo Nordisk Production Ireland Limited

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

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Registered sites: 1
Active NDC listings: 5
Live patents: 0
Countries: 1
Base: Ireland

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Novo Nordisk Production Ireland Limited	Monksland Industrial Estate, ATHLONE, CO WESTMEATH N37 EA09, Ireland (IRL)	Analytical testing, Finished drug manufacture	3002806873984911126

Catalogue

Drug listings by form and route

5 active NDC listings: 5 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 5.

Dosage form	NDCs
capsule	2
capsule, delayed release	1
powder, for suspension	1
suspension	1

Route	NDCs

Labeller name on the listing	NDCs
novo nordisk production ireland limited	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	aprepitant	capsule	56125-632DRUG FOR FURTHER PROCESSING
-	aprepitant	capsule	56125-633DRUG FOR FURTHER PROCESSING
-	aprepitant	powder, for suspension	56125-634DRUG FOR FURTHER PROCESSING
-	diroximel fumarate	capsule, delayed release	56125-700DRUG FOR FURTHER PROCESSING
-	sirolimus	suspension	56125-800DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

Almac Pharma Services (Ireland) LimitedAthlone, IRL
Alexion Pharmaceuticals, Inc.Athlone, IRL
Jazz Pharmaceuticals Operations UK LimitedAthlone, IRL
PPD Development, L.P.Athlone, IRL

Compare

Comparable companies in Ireland

Amneal Ireland Limited1 site · 513 NDC
Clarochem Ireland Limited1 site · 3 NDC
Upjohn Manufacturing Ireland Unlimited Company1 site · 2 NDC
MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED1 site · 1 NDC
Eirgen Pharma Ltd1 site · 0 NDC
HELSINN BIREX PHARMACEUTICALS LIMITED1 site · 0 NDC
NORTON (WATERFORD) LIMITED1 site · 0 NDC
IPSEN MANUFACTURING IRELAND LIMITED2 sites · 17 NDC
SK BIOTEK2 sites · 10 NDC
LIEBEL-FLARSHEIM COMPANY LLC.2 sites · 7 NDC

Enquiry

Common questions

Is Novo Nordisk Production Ireland Limited FDA approved?: Novo Nordisk Production Ireland Limited holds 1 FDA-registered establishment in Ireland. 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 Novo Nordisk Production Ireland Limited's drugs manufactured?: The FDA register lists ATHLONE. Registered operations: analytical testing, finished drug manufacture.
What drugs does Novo Nordisk Production Ireland Limited make?: 5 products are listed under Novo Nordisk Production Ireland Limited in the openFDA NDC Directory, most often as capsule; capsule, delayed release; powder, for suspension. 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.