Is IDT Biologika GmbH FDA approved?

IDT Biologika 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 IDT Biologika GmbH's drugs manufactured?

The FDA register lists Dessau-Rosslau. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.

What drugs does IDT Biologika GmbH make?

2 products are listed under IDT Biologika GmbH in the openFDA NDC Directory, most often as injection, suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

IDT Biologika GmbH

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 2
Live patents: 0
Countries: 1
Base: Germany

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
IDT Biologika GmbH	Am Pharmapark, Dessau-Rosslau, Saxony-Anhalt 06861, Germany (DEU)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize	3005001757332119734

Catalogue

Drug listings by form and route

2 active NDC listings: 2 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 2.

Dosage form	NDCs
injection, suspension	2

Route	NDCs

Labeller name on the listing	NDCs
idt biologika gmbh	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	talimogene laherparepvec	injection, suspension	60152-002DRUG FOR FURTHER PROCESSING
-	talimogene laherparepvec	injection, suspension	60152-003DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

Merz Pharma GmbH & Co. KGaADessau-Rosslau, DEU

Compare

Comparable companies in Germany

Excella GmbH & Co. KG1 site · 73 NDC
PEKANA Naturheilmittel GmbH1 site · 62 NDC
Grillo Zinc Powder GmbH1 site · 22 NDC
Nestmann Pharma GMBH1 site · 18 NDC
Rottendorf Pharma GmbH1 site · 17 NDC
Arevipharma GmbH1 site · 13 NDC
Chemische Fabrik Berg GmbH1 site · 13 NDC
Eckert & Ziegler Radiopharma GmbH1 site · 11 NDC
Heraeus Precious Metals GmbH Co KG1 site · 10 NDC
Solupharm Pharmazeutische Erzeugnisse GmbH1 site · 10 NDC

Enquiry

Common questions

Is IDT Biologika GmbH FDA approved?: IDT Biologika 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 IDT Biologika GmbH's drugs manufactured?: The FDA register lists Dessau-Rosslau. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
What drugs does IDT Biologika GmbH make?: 2 products are listed under IDT Biologika GmbH in the openFDA NDC Directory, most often as injection, 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.