Is GENTEC S.A. FDA approved?

GENTEC S.A. holds 1 FDA-registered establishment in Spain. 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 GENTEC S.A.'s drugs manufactured?

The FDA register lists AVINYONET DEL PENEDES. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does GENTEC S.A. make?

1 product is listed under GENTEC S.A. in the openFDA NDC Directory, most often as oil. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

GENTEC S.A.

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

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

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
GENTEC S.A.	TRAMONTANA 3, AVINYONET DEL PENEDES, 08793, Spain (ESP)	Analytical testing, Active ingredient (API) manufacture	3019432058466190306

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Latanoprost	oil	81997-001BULK INGREDIENT

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Enquiry

Common questions

Is GENTEC S.A. FDA approved?: GENTEC S.A. holds 1 FDA-registered establishment in Spain. 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 GENTEC S.A.'s drugs manufactured?: The FDA register lists AVINYONET DEL PENEDES. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does GENTEC S.A. make?: 1 product is listed under GENTEC S.A. in the openFDA NDC Directory, most often as oil. 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.