Is Roquette Freres SA FDA approved?

Roquette Freres SA 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 Roquette Freres SA's drugs manufactured?

The FDA register lists Lestrem. Registered operations: active ingredient (API) manufacture.

What drugs does Roquette Freres SA make?

5 products are listed under Roquette Freres SA 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.

Roquette Freres SA

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

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Registered sites: 1
Active NDC listings: 5
Live patents: 0
Countries: 1
Base: France

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Roquette Freres SA	1 Rue de la Haute Loge, Lestrem, Pas-de-Calais 62136, France (FRA)	Active ingredient (API) manufacture	1000114558274300938

Catalogue

Drug listings by form and route

5 active NDC listings: 5 bulk ingredient. By marketing category: BULK INGREDIENT 5.

Dosage form	NDCs
powder	5

Route	NDCs

Labeller name on the listing	NDCs
roquette freres sa	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	ADRABETADEX	powder	50516-003BULK INGREDIENT
-	DEXTROSE MONOHYDRATE	powder	50516-001BULK INGREDIENT
-	MANNITOL	powder	50516-002BULK INGREDIENT
-	SODIUM GLUCONATE	powder	50516-004BULK INGREDIENT
-	SORBITOL	powder	50516-005BULK INGREDIENT

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Common questions

Is Roquette Freres SA FDA approved?: Roquette Freres SA 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 Roquette Freres SA's drugs manufactured?: The FDA register lists Lestrem. Registered operations: active ingredient (API) manufacture.
What drugs does Roquette Freres SA make?: 5 products are listed under Roquette Freres SA 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.