Is SERATEC FDA approved?

SERATEC holds 1 FDA-registered establishment in France. 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 SERATEC's drugs manufactured?

The FDA register lists COURVILLE SUR EURE. Registered operations: active ingredient (API) manufacture.

What drugs does SERATEC make?

4 products are listed under SERATEC 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.

SERATEC

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
SERATEC	VILLAGES DES ENTERPRISES 2 RUE DU THYMERAIS RTE BILLANCEL, COURVILLE SUR EURE, 28190, France (FRA)	Active ingredient (API) manufacture	3003666337277218525

Catalogue

Drug listings by form and route

4 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT 4.

Dosage form	NDCs
powder	4

Route	NDCs

Labeller name on the listing	NDCs
seratec	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Bethanechol Chloride	powder	65732-121BULK INGREDIENT
-	Carbachol	powder	65732-131BULK INGREDIENT
-	Fomepizole	powder	65732-702BULK INGREDIENT
-	Quinacrine Dihydrochloride	powder	65732-202BULK INGREDIENT

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Enquiry

Common questions

Is SERATEC FDA approved?: SERATEC holds 1 FDA-registered establishment in France. 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 SERATEC's drugs manufactured?: The FDA register lists COURVILLE SUR EURE. Registered operations: active ingredient (API) manufacture.
What drugs does SERATEC make?: 4 products are listed under SERATEC 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.