Is DOTTIKON EXCLUSIVE SYNTHESIS AG FDA approved?

DOTTIKON EXCLUSIVE SYNTHESIS AG 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 DOTTIKON EXCLUSIVE SYNTHESIS AG's drugs manufactured?

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

What drugs does DOTTIKON EXCLUSIVE SYNTHESIS AG make?

16 products are listed under DOTTIKON EXCLUSIVE SYNTHESIS AG 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.

DOTTIKON EXCLUSIVE SYNTHESIS AG

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 16
Live patents: 0
Countries: 1
Base: Switzerland

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
DOTTIKON EXCLUSIVE SYNTHESIS AG	Hembrunnstrasse 17, Dottikon, Aargau 5605, Switzerland (CHE)	Analytical testing, Active ingredient (API) manufacture	3002806909480000413

Catalogue

Drug listings by form and route

16 active NDC listings: 16 bulk ingredient. By marketing category: BULK INGREDIENT 16.

Dosage form	NDCs
powder	16

Route	NDCs

Labeller name on the listing	NDCs
dottikon exclusive synthesis ag	16

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	ACALABRUTINIB MALEATE	powder	54864-601BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	54864-666BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	54864-668BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	54864-669BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	54864-670BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	54864-671BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	54864-672BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	54864-673BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	54864-674BULK INGREDIENT
-	Dimethyl fumarate	powder	54864-663BULK INGREDIENT
-	ISOSORBIDE DINITRATE, DILUTED	powder	54864-106BULK INGREDIENT
-	Ivosidenib	powder	54864-720BULK INGREDIENT
-	OLAPARIB	powder	54864-843BULK INGREDIENT
-	Osimertinib	powder	54864-844BULK INGREDIENT
-	Sapropterin dihydrochloride	powder	54864-872BULK INGREDIENT
-	Selumetinib Hyd Sulfate	powder	54864-874BULK INGREDIENT

Compare

Comparable companies in Switzerland

Herbamed AG1 site · 173 NDC
Avyxa GmbH1 site · 29 NDC
Bachem AG1 site · 23 NDC
Vifor (International) AG1 site · 22 NDC
HAS Healthcare Advanced Synthesis SA1 site · 11 NDC
Cerbios-Pharma SA1 site · 9 NDC
SINTETICA S.A.1 site · 9 NDC
Bachem SA, Succursale de Vionnaz1 site · 5 NDC
MICRO-MACINAZIONE SA1 site · 5 NDC
Debiopharm Research & Manufacturing SA1 site · 4 NDC

Enquiry

Common questions

Is DOTTIKON EXCLUSIVE SYNTHESIS AG FDA approved?: DOTTIKON EXCLUSIVE SYNTHESIS AG 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 DOTTIKON EXCLUSIVE SYNTHESIS AG's drugs manufactured?: The FDA register lists Dottikon. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does DOTTIKON EXCLUSIVE SYNTHESIS AG make?: 16 products are listed under DOTTIKON EXCLUSIVE SYNTHESIS AG 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.