Is Farmhispania S.A. FDA approved?

Farmhispania 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 Farmhispania S.A.'s drugs manufactured?

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

What drugs does Farmhispania S.A. make?

17 products are listed under Farmhispania S.A. in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Farmhispania S.A.

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

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Registered sites: 1
Active NDC listings: 17
Labeller names: 2
Live patents: 0
Countries: 1
Base: Spain

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Farmhispania S.A.	Passeig Riu Besos, 9-10, Montmelo, 08160, Spain (ESP)	Analytical testing, Active ingredient (API) manufacture	3002806964462038145

Catalogue

Drug listings by form and route

17 active NDC listings: 17 bulk ingredient. By marketing category: BULK INGREDIENT 16, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.

Dosage form	NDCs
powder	17

Route	NDCs

Labeller name on the listing	NDCs
farmhispania, s.a.	11
farmhispania s.a.	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Atracurium Besylate	powder	17404-0008BULK INGREDIENT
-	Benazepril Hydrochloride	powder	17404-0016BULK INGREDIENT
-	Cisatracurium Besylate	powder	17404-1024BULK INGREDIENT
-	Decitabine	powder	17404-1029BULK INGREDIENT
-	Deutetrabenazine	powder	17404-1031BULK INGREDIENT
-	Deutetrabenazine micronized	powder	17404-1032BULK INGREDIENT
-	Enalapril Maleate	powder	17404-0009BULK INGREDIENT
-	Everolimus	powder	17404-1027BULK INGREDIENT
-	Everolimus	powder	17404-1034BULK INGREDIENT
-	Gemcitabine Hydrochloride	powder	17404-1033BULK INGREDIENT
-	Metformin Hydrochloride	powder	17404-0012BULK INGREDIENT
-	Metformin Hydrochloride	powder	17404-1028BULK INGREDIENT
-	Milrinone	powder	17404-0017BULK INGREDIENT
-	Quinapril Hydrochloride	powder	17404-0015BULK INGREDIENT
-	Rocuronium Bromide	powder	17404-1022BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Rocuronium Bromide	powder	17404-1035BULK INGREDIENT
-	Sugammadex	powder	17404-1030BULK INGREDIENT

Neighbours

Registered in the same town

PURAC BIOQUIMICA SAMontmelo, ESP

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Enquiry

Common questions

Is Farmhispania S.A. FDA approved?: Farmhispania 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 Farmhispania S.A.'s drugs manufactured?: The FDA register lists Montmelo. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Farmhispania S.A. make?: 17 products are listed under Farmhispania S.A. in the openFDA NDC Directory, most often as powder. 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.