Is Benechim FDA approved?

Benechim holds 1 FDA-registered establishment in Belgium. 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 Benechim's drugs manufactured?

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

What drugs does Benechim make?

5 products are listed under Benechim 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.

Benechim

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

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Registered sites: 1
Active NDC listings: 5
Labeller names: 2
Live patents: 0
Countries: 1
Base: Belgium

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Benechim	Rue Rene Magritte 163, Lessines, 7860, Belgium (BEL)	Active ingredient (API) manufacture	3004293182282963222

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
benechim	4
benechim	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	ARTICAINE HYDROCHLORIDE	powder	53335-0001BULK INGREDIENT
-	Metoprolol Succinate	powder	53335-0005BULK INGREDIENT
-	PRILOCAINE HYDROCHLORIDE	powder	53335-0002BULK INGREDIENT
-	Prilocaine	powder	53335-0004BULK INGREDIENT
-	Ropivacaine HCl	powder	53335-0003BULK INGREDIENT

Neighbours

Registered in the same town

Baxter Healthcare CorporationLessines, BEL
Baxalta US Inc.Lessines, BEL

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Enquiry

Common questions

Is Benechim FDA approved?: Benechim holds 1 FDA-registered establishment in Belgium. 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 Benechim's drugs manufactured?: The FDA register lists Lessines. Registered operations: active ingredient (API) manufacture.
What drugs does Benechim make?: 5 products are listed under Benechim 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.