Is Bioseutica B.V. FDA approved?

Bioseutica B.V. holds 2 FDA-registered establishments in the Netherlands. 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 Bioseutica B.V.'s drugs manufactured?

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

What drugs does Bioseutica B.V. make?

1 product is listed under Bioseutica B.V. 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.

Bioseutica B.V.

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

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Registered sites: 2
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: Netherlands

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
LMC Lysozyme Manufacturing Company B.V.Registrant: Bioseutica B.V.	Energieweg 9, Nunspeet, 8071DA, Netherlands (NLD)	Active ingredient (API) manufacture	3015537077413955597
Bioseutica B.V.	Landbouwweg 83, Zeewolde, Netherlands 3899BD, Netherlands (NLD)	Analytical testing	3004403003489080758

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Lysozyme HCl	powder	84319-103BULK INGREDIENT

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Enquiry

Common questions

Is Bioseutica B.V. FDA approved?: Bioseutica B.V. holds 2 FDA-registered establishments in the Netherlands. 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 Bioseutica B.V.'s drugs manufactured?: The FDA register lists Nunspeet; Zeewolde. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Bioseutica B.V. make?: 1 product is listed under Bioseutica B.V. 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.