Is HIKMA FARMACEUTICA (PORTUGAL), S.A. FDA approved?

HIKMA FARMACEUTICA (PORTUGAL), S.A. holds 1 FDA-registered establishment in Portugal. 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 HIKMA FARMACEUTICA (PORTUGAL), S.A.'s drugs manufactured?

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

HIKMA FARMACEUTICA (PORTUGAL), S.A.

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: Portugal

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
HIKMA FARMACEUTICA (PORTUGAL), S.ARegistrant: HIKMA FARMACEUTICA (PORTUGAL), S.A.	ESTRADA RIO DA MO, 8/8A/8B, TERRUGEM SINTRA, 2705-906, Portugal (PRT)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002807173452742943

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Common questions

Is HIKMA FARMACEUTICA (PORTUGAL), S.A. FDA approved?: HIKMA FARMACEUTICA (PORTUGAL), S.A. holds 1 FDA-registered establishment in Portugal. 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 HIKMA FARMACEUTICA (PORTUGAL), S.A.'s drugs manufactured?: The FDA register lists TERRUGEM SINTRA. Registered operations: analytical testing, 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.