Is Rolabo Outsourcing S.L. FDA approved?

Rolabo Outsourcing S.L. 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 Rolabo Outsourcing S.L.'s drugs manufactured?

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

What drugs does Rolabo Outsourcing S.L. make?

9 products are listed under Rolabo Outsourcing S.L. 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.

Rolabo Outsourcing S.L.

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

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Registered sites: 1
Active NDC listings: 9
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
Rolabo Outsourcing S.L.	Poligono Industrial Malpica, Calle J, Parcelas 3-4, Zaragoza, 50016, Spain (ESP)	Analytical testing, Active ingredient (API) manufacture	3003688035513603225

Catalogue

Drug listings by form and route

9 active NDC listings: 9 bulk ingredient. By marketing category: BULK INGREDIENT 9.

Dosage form	NDCs
powder	9

Route	NDCs

Labeller name on the listing	NDCs
rolabo outsourcing s.l.	7
rolabo outsourcing, s.l.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	ATROPINE	powder	63827-1015BULK INGREDIENT
-	ATROPINE SULFATE	powder	63827-1014BULK INGREDIENT
-	Cannabidiol	powder	63827-1017BULK INGREDIENT
-	Deutetrabenazine	powder	63827-1018BULK INGREDIENT
-	Loratadine	powder	63827-0001BULK INGREDIENT
-	Palonosetron Hydrochloride	powder	63827-1011BULK INGREDIENT
-	Quinapril Hydrochloride	powder	63827-1009BULK INGREDIENT
-	TETRABENAZINE	powder	63827-1013BULK INGREDIENT
-	ZAVEGEPANT HYDROCHLORIDE	powder	63827-1019BULK INGREDIENT

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Enquiry

Common questions

Is Rolabo Outsourcing S.L. FDA approved?: Rolabo Outsourcing S.L. 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 Rolabo Outsourcing S.L.'s drugs manufactured?: The FDA register lists Zaragoza. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Rolabo Outsourcing S.L. make?: 9 products are listed under Rolabo Outsourcing S.L. 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.