Is Biomedica spol s.r.o. FDA approved?

Biomedica spol s.r.o. holds 1 FDA-registered establishment in Czechia. 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 Biomedica spol s.r.o.'s drugs manufactured?

The FDA register lists Hor�tev. Registered operations: labelling, finished drug manufacture, packaging, relabelling, repackaging.

Biomedica spol s.r.o.

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

Request a quote Claim this profile

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

Authorisation

Registered operations

Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Biomedica, spol. s r.o.Registrant: Biomedica spol s.r.o.	Hor�tev 104, Hor�tev, 289 13, Czech Republic (CZE)	Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3011715956986844720

Neighbours

Registered in the same town

Fenwal, Inc.Hor�tev, CZE

Compare

Comparable companies in Czechia

Teva Czech Industries s.r.o.1 site · 41 NDC
TAPI Czech Industries s.r.o.1 site · 32 NDC
Synthon Pharmaceuticals, Inc.4 sites · 1 NDC

Enquiry

Common questions

Is Biomedica spol s.r.o. FDA approved?: Biomedica spol s.r.o. holds 1 FDA-registered establishment in Czechia. 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 Biomedica spol s.r.o.'s drugs manufactured?: The FDA register lists Hor�tev. Registered operations: labelling, finished drug manufacture, packaging, relabelling, repackaging.

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.