Is Synthon Pharmaceuticals, Inc. FDA approved?

Synthon Pharmaceuticals, Inc. holds 4 FDA-registered establishments across 4 countries. 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 Synthon Pharmaceuticals, Inc.'s drugs manufactured?

At registered sites in Argentina, Chile, Czechia, Spain. The FDA register lists San Lorenzo; Santiago; Blansko; Sant Boi de Llobregat. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Synthon Pharmaceuticals, Inc. make?

1 product is listed under Synthon Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Synthon Pharmaceuticals, Inc.

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

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Registered sites: 4
Active NDC listings: 1
Live patents: 0
Countries: 4
Base: Czechia

Authorisation

Registered operations

Analytical testing4Active ingredient (API) manufacture2Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Synthon Argentina S.A.Registrant: Synthon Pharmaceuticals, Inc.	Ruta Nacional Nro 11, Km. 325, San Lorenzo, Santa Fe S2200MEC, Argentina (ARG)	Analytical testing, Active ingredient (API) manufacture	3005619726979421112
Synthon Chile LimitadaRegistrant: Synthon Pharmaceuticals, Inc.	El Castano 145, Santiago, Santiago 9391521, Chile (CHL)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3014115543981236297
Synthon s.r.o.Registrant: Synthon Pharmaceuticals, Inc.	Brnenska 597/32, Blansko, 67801, Czech Republic (CZE)	Analytical testing, Active ingredient (API) manufacture	3005212485366950413
Synthon Hispania S.L.Registrant: Synthon Pharmaceuticals, Inc.	Calle Castello, 1 - PG Salinas, Sant Boi de Llobregat, 08830, Spain (ESP)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3004837462460486264

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Tamsulosin hydrochloride	tamsulosin hydrochloride	capsule, oral	63672-0021ANDA

Neighbours

Registered in the same town

Procesadora Insuban SpASantiago, CHL

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Enquiry

Common questions

Is Synthon Pharmaceuticals, Inc. FDA approved?: Synthon Pharmaceuticals, Inc. holds 4 FDA-registered establishments across 4 countries. 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 Synthon Pharmaceuticals, Inc.'s drugs manufactured?: At registered sites in Argentina, Chile, Czechia, Spain. The FDA register lists San Lorenzo; Santiago; Blansko; Sant Boi de Llobregat. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Synthon Pharmaceuticals, Inc. make?: 1 product is listed under Synthon Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as 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.