Is Merck SLU FDA approved?

Merck SLU 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 Merck SLU's drugs manufactured?

The FDA register lists Mollet del Valles. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Merck SLU

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: Spain

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Merck SLRegistrant: Merck SLU	Poligono Industrial Merck, Mollet del Valles, 08100, Spain (ESP)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002649889460082644

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Common questions

Is Merck SLU FDA approved?: Merck SLU 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 Merck SLU's drugs manufactured?: The FDA register lists Mollet del Valles. Registered operations: analytical testing, active ingredient (API) manufacture, 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.