Is AGC Pharma Chemicals Europe, S.L.U . FDA approved?

AGC Pharma Chemicals Europe, S.L.U . 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 AGC Pharma Chemicals Europe, S.L.U .'s drugs manufactured?

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

What drugs does AGC Pharma Chemicals Europe, S.L.U . make?

7 products are listed under AGC Pharma Chemicals Europe, S.L.U . in the openFDA NDC Directory, most often as powder; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

AGC Pharma Chemicals Europe, S.L.U .

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

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Registered sites: 1
Active NDC listings: 7
Live patents: 0
Countries: 1
Base: Spain

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
AGC Pharma Chemicals Europe, S.L.U .	Cam� de la Pomereda, 13, Malgrat de Mar, Barcelona 08380, Spain (ESP)	Analytical testing, Active ingredient (API) manufacture	3002806459468215759

Catalogue

Drug listings by form and route

7 active NDC listings: 7 bulk ingredient. By marketing category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 5, BULK INGREDIENT 2.

Dosage form	NDCs
powder	6
capsule	1

Route	NDCs

Labeller name on the listing	NDCs
agc pharma chemicals europe, s.l.u.	7

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	DIPYRIDAMOLE	powder	65404-005BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Dapiprazole Hydrochloride	powder	65404-008BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Pimobendan	powder	65404-004BULK INGREDIENT
-	TELMISARTAN	powder	65404-006BULK INGREDIENT
-	TELMISARTAN	powder	65404-007BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Taletrectinib adipate	capsule	65404-009BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Taletrectinib adipate	powder	65404-010BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

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Enquiry

Common questions

Is AGC Pharma Chemicals Europe, S.L.U . FDA approved?: AGC Pharma Chemicals Europe, S.L.U . 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 AGC Pharma Chemicals Europe, S.L.U .'s drugs manufactured?: The FDA register lists Malgrat de Mar. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does AGC Pharma Chemicals Europe, S.L.U . make?: 7 products are listed under AGC Pharma Chemicals Europe, S.L.U . in the openFDA NDC Directory, most often as powder; capsule. 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.