Is ROTOP Pharmaka GmbH FDA approved?

ROTOP Pharmaka 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 ROTOP Pharmaka GmbH's drugs manufactured?

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

ROTOP Pharmaka GmbH

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

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

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ROTOP Pharmaka GmbH	Bautzner Landstrasse 400, Dresden, saxony 01328, Germany (DEU)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3009075542314666202

Neighbours

Registered in the same town

GlaxoSmithKline Biologicals SADresden, DEU

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Enquiry

Common questions

Is ROTOP Pharmaka GmbH FDA approved?: ROTOP Pharmaka 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 ROTOP Pharmaka GmbH's drugs manufactured?: The FDA register lists Dresden. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

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.