Is SINTETICA S.A. FDA approved?

SINTETICA S.A. holds 1 FDA-registered establishment in Switzerland. 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 SINTETICA S.A.'s drugs manufactured?

The FDA register lists MENDRISIO. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does SINTETICA S.A. make?

9 products are listed under SINTETICA S.A. in the openFDA NDC Directory, most often as injection; injection, solution; injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

SINTETICA S.A.

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: Switzerland

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
SINTETICA S.A.	VIA PENATE 5, MENDRISIO, TI 6850, Switzerland (CHE)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3004058163480895478

Catalogue

Drug listings by form and route

9 active NDC listings: 9 human prescription drug. By marketing category: ANDA 5, DRUG FOR FURTHER PROCESSING 4.

Dosage form	NDCs
injection	5
injection, solution	2
injection, powder, lyophilized, for solution	1
injection, powder, lyophilized, for suspension	1

Route	NDCs
intravenous	5
subcutaneous	1

Labeller name on the listing	NDCs
sintetica us llc	5
sintetica s.a.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ARSENIC TRIOXIDE	arsenic trioxide	injection, solution, intravenous	83090-009ANDA
ARSENIC TRIOXIDE	arsenic trioxide	injection, solution, intravenous	83090-010ANDA
-	Baclofen	injection	68055-001DRUG FOR FURTHER PROCESSING
-	Baclofen	injection	68055-002DRUG FOR FURTHER PROCESSING
-	Baclofen	injection	68055-003DRUG FOR FURTHER PROCESSING
-	Baclofen	injection	68055-004DRUG FOR FURTHER PROCESSING
Bortezomib	Bortezomib	injection, powder, lyophilized, for solution, intravenous, subcutaneous	83090-008ANDA
Lacosamide	lacosamide	injection, intravenous	83090-012ANDA
daptomycin	daptomycin	injection, powder, lyophilized, for suspension, intravenous	83090-011ANDA

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Enquiry

Common questions

Is SINTETICA S.A. FDA approved?: SINTETICA S.A. holds 1 FDA-registered establishment in Switzerland. 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 SINTETICA S.A.'s drugs manufactured?: The FDA register lists MENDRISIO. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does SINTETICA S.A. make?: 9 products are listed under SINTETICA S.A. in the openFDA NDC Directory, most often as injection; injection, solution; injection, powder, lyophilized, for solution. 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.