Is MABXIENCE SAU FDA approved?

MABXIENCE SAU holds 1 FDA-registered establishment in Argentina. 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 MABXIENCE SAU's drugs manufactured?

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

MABXIENCE SAU

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: Argentina

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
MABXIENCE S.A.U.Registrant: MABXIENCE SAU	Zabala 1040,, Garin, B1619JNA, Argentina (ARG)	Analytical testing, Active ingredient (API) manufacture	3017999629978797835

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Common questions

Is MABXIENCE SAU FDA approved?: MABXIENCE SAU holds 1 FDA-registered establishment in Argentina. 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 MABXIENCE SAU's drugs manufactured?: The FDA register lists Garin. Registered operations: analytical testing, active ingredient (API) manufacture.

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.