Is Wasserburger Arzneimittelwerk GmbH FDA approved?

Wasserburger Arzneimittelwerk GmbH holds 1 FDA-registered establishment in Germany. 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 Wasserburger Arzneimittelwerk GmbH's drugs manufactured?

The FDA register lists Wasserburg a Inn. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Wasserburger Arzneimittelwerk GmbH make?

4 products are listed under Wasserburger Arzneimittelwerk GmbH in the openFDA NDC Directory, most often as injection, powder, for solution; injection, powder, lyophilized, for solution; powder, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Wasserburger Arzneimittelwerk GmbH

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

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Registered sites: 1
Active NDC listings: 4
Live patents: 0
Countries: 1
Base: Germany

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Wasserburger Arzneimittelwerk GmbH	Herderstrasse 2, Wasserburg a Inn, 83512, Germany (DEU)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002806849326482247

Catalogue

Drug listings by form and route

4 active NDC listings: 4 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 4.

Dosage form	NDCs
injection, powder, for solution	1
injection, powder, lyophilized, for solution	1
powder, for solution	1
solution	1

Route	NDCs

Labeller name on the listing	NDCs
wasserburger arzneimittelwerk gmbh	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Epoprostenol	injection, powder, lyophilized, for solution	62287-123DRUG FOR FURTHER PROCESSING
-	Ferric Derisomaltose	solution	62287-931DRUG FOR FURTHER PROCESSING
-	Pantoprazole Sodium	injection, powder, for solution	62287-923DRUG FOR FURTHER PROCESSING
-	Somatropin	powder, for solution	62287-190DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is Wasserburger Arzneimittelwerk GmbH FDA approved?: Wasserburger Arzneimittelwerk GmbH holds 1 FDA-registered establishment in Germany. 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 Wasserburger Arzneimittelwerk GmbH's drugs manufactured?: The FDA register lists Wasserburg a Inn. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Wasserburger Arzneimittelwerk GmbH make?: 4 products are listed under Wasserburger Arzneimittelwerk GmbH in the openFDA NDC Directory, most often as injection, powder, for solution; injection, powder, lyophilized, for solution; powder, for 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.