Is Pliva Hrvatska d.o.o. FDA approved?

Pliva Hrvatska d.o.o. holds 1 FDA-registered establishment in Croatia. 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 Pliva Hrvatska d.o.o.'s drugs manufactured?

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

Pliva Hrvatska d.o.o.

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: Croatia

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1Repackaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Pliva Hrvatska d.o.o.	Prilaz Baruna Filipovica 25, Zagreb, 10000, Croatia (HRV)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging, sterilize	3002807904499659316

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Common questions

Is Pliva Hrvatska d.o.o. FDA approved?: Pliva Hrvatska d.o.o. holds 1 FDA-registered establishment in Croatia. 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 Pliva Hrvatska d.o.o.'s drugs manufactured?: The FDA register lists Zagreb. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, repackaging, sterilize.

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.