Is Novo Nordisk Production Belgium SA FDA approved?

Novo Nordisk Production Belgium SA holds 2 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 Novo Nordisk Production Belgium SA's drugs manufactured?

At registered sites in Belgium, Italy. The FDA register lists Brussels; ANAGNI (FONTANA DEL CERASO). Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Novo Nordisk Production Belgium SA make?

24 products are listed under Novo Nordisk Production Belgium SA in the openFDA NDC Directory, most often as injection, solution; injection; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Novo Nordisk Production Belgium SA

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

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Registered sites: 2
Active NDC listings: 24
Live patents: 0
Countries: 2
Base: Italy

Authorisation

Registered operations

Analytical testing2Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Novo Nordisk Production Belgium SA	Font Saint Landry 10, Brussels, - 1120, Belgium (BEL)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3007647000370696762
Catalent Anagni S.R.L.Registrant: Novo Nordisk Production Belgium SA	STRADA PROVINCIALE 12 CASILINA 41, ANAGNI (FONTANA DEL CERASO), Frosinone 03012, Italy (ITA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002806546440438790

Catalogue

Drug listings by form and route

24 active NDC listings: 24 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 24.

Dosage form	NDCs
injection, solution	13
injection	6
solution	5

Route	NDCs

Labeller name on the listing	NDCs
novo nordisk production belgium sa	24

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Adalimumab	injection	43835-0033DRUG FOR FURTHER PROCESSING
-	Adalimumab	injection	43835-0035DRUG FOR FURTHER PROCESSING
-	Adalimumab	injection	43835-0036DRUG FOR FURTHER PROCESSING
-	BREMELANOTIDE	injection	43835-0025DRUG FOR FURTHER PROCESSING
-	Denosumab	injection	43835-0053DRUG FOR FURTHER PROCESSING
-	Epinephrine	injection	43835-0026DRUG FOR FURTHER PROCESSING
-	Hiberix-Hiberix	injection, solution	43835-0038DRUG FOR FURTHER PROCESSING
-	Priorix	solution	43835-0034DRUG FOR FURTHER PROCESSING
-	Rotarix	solution	43835-0015DRUG FOR FURTHER PROCESSING
-	Semaglutide	injection, solution	43835-0055DRUG FOR FURTHER PROCESSING
-	Semaglutide	injection, solution	43835-0056DRUG FOR FURTHER PROCESSING
-	Semaglutide	injection, solution	43835-0057DRUG FOR FURTHER PROCESSING
-	Semaglutide	injection, solution	43835-0058DRUG FOR FURTHER PROCESSING
-	Semaglutide	injection, solution	43835-0059DRUG FOR FURTHER PROCESSING
-	Sterile Diluent	solution	43835-0017DRUG FOR FURTHER PROCESSING
-	Sterile Diluent	solution	43835-0018DRUG FOR FURTHER PROCESSING
-	Sterile Water	solution	43835-0016DRUG FOR FURTHER PROCESSING
-	nirsevimab	injection, solution	43835-0051DRUG FOR FURTHER PROCESSING
-	nirsevimab	injection, solution	43835-0052DRUG FOR FURTHER PROCESSING
-	semaglutide	injection, solution	43835-0028DRUG FOR FURTHER PROCESSING
-	semaglutide	injection, solution	43835-0029DRUG FOR FURTHER PROCESSING
-	semaglutide	injection, solution	43835-0030DRUG FOR FURTHER PROCESSING
-	semaglutide	injection, solution	43835-0031DRUG FOR FURTHER PROCESSING
-	semaglutide	injection, solution	43835-0032DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is Novo Nordisk Production Belgium SA FDA approved?: Novo Nordisk Production Belgium SA holds 2 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 Novo Nordisk Production Belgium SA's drugs manufactured?: At registered sites in Belgium, Italy. The FDA register lists Brussels; ANAGNI (FONTANA DEL CERASO). Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Novo Nordisk Production Belgium SA make?: 24 products are listed under Novo Nordisk Production Belgium SA in the openFDA NDC Directory, most often as injection, solution; injection; solution. 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.