Is Fidelio Healthcare Limburg GmbH FDA approved?

Fidelio Healthcare Limburg 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 Fidelio Healthcare Limburg GmbH's drugs manufactured?

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

What drugs does Fidelio Healthcare Limburg GmbH make?

6 products are listed under Fidelio Healthcare Limburg GmbH in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Fidelio Healthcare Limburg GmbH

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

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Registered sites: 1
Active NDC listings: 6
Live patents: 0
Countries: 1
Base: Germany

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Fidelio Healthcare Limburg GmbH	Mundipharmastr. 2, Limburg, Hessen 65549, Germany (DEU)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1000449371314929379

Catalogue

Drug listings by form and route

6 active NDC listings: 6 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 6.

Dosage form	NDCs
tablet, film coated	6

Route	NDCs

Labeller name on the listing	NDCs
fidelio healthcare limburg gmbh	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	OLANZAPINE	tablet, film coated	87383-005DRUG FOR FURTHER PROCESSING
-	OLANZAPINE	tablet, film coated	87383-006DRUG FOR FURTHER PROCESSING
-	OLANZAPINE	tablet, film coated	87383-007DRUG FOR FURTHER PROCESSING
-	OLANZAPINE	tablet, film coated	87383-008DRUG FOR FURTHER PROCESSING
-	OLANZAPINE	tablet, film coated	87383-009DRUG FOR FURTHER PROCESSING
-	OLANZAPINE	tablet, film coated	87383-010DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is Fidelio Healthcare Limburg GmbH FDA approved?: Fidelio Healthcare Limburg 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 Fidelio Healthcare Limburg GmbH's drugs manufactured?: The FDA register lists Limburg. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Fidelio Healthcare Limburg GmbH make?: 6 products are listed under Fidelio Healthcare Limburg GmbH in the openFDA NDC Directory, most often as tablet, film coated. 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.