Is FARMASIERRA MANUFACTURING SL FDA approved?

FARMASIERRA MANUFACTURING SL 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 FARMASIERRA MANUFACTURING SL's drugs manufactured?

The FDA register lists San Sebastian de los Reyes. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does FARMASIERRA MANUFACTURING SL make?

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

FARMASIERRA MANUFACTURING SL

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 testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
FARMASIERRA MANUFACTURING SL	Carretera de Ir�n Km 26,200, San Sebastian de los Reyes, Madrid 28706, Spain (ESP)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3007898507466799991

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
LEDERLE LEUCOVORIN	CALCIUM FOLINATE	tablet, oral	73591-5886UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE

Neighbours

Registered in the same town

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.San Sebastian de los Reyes, ESP

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Enquiry

Common questions

Is FARMASIERRA MANUFACTURING SL FDA approved?: FARMASIERRA MANUFACTURING SL 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 FARMASIERRA MANUFACTURING SL's drugs manufactured?: The FDA register lists San Sebastian de los Reyes. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does FARMASIERRA MANUFACTURING SL make?: 1 product is listed under FARMASIERRA MANUFACTURING SL in the openFDA NDC Directory, most often as tablet. 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.