Is Biocodex FDA approved?

Biocodex holds 2 FDA-registered establishments across 2 countries. 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 Biocodex's drugs manufactured?

At registered sites in France, the United States. The FDA register lists Beauvais; Bedminster, NJ. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does Biocodex make?

4 products are listed under Biocodex in the openFDA NDC Directory, most often as capsule; powder, for suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Biocodex

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

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Registered sites: 2
Active NDC listings: 4
Live patents: 0
Countries: 2
Base: France

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture2Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Biocodex	1 avenue Blaise Pascal, Beauvais, 60000, France (FRA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3003346516394954077
BIOCODEX, INC.	550 Hills Drive, Suite 200B, Bedminster, New Jersey (NJ) 07921, United States (USA)	Finished drug manufacture	3008266623117982460

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
capsule	2
powder, for suspension	2

Route	NDCs
oral	4

Labeller name on the listing	NDCs
biocodex, inc.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Diacomit	stiripentol	capsule, oral	68418-7939NDA
Diacomit	stiripentol	capsule, oral	68418-7940NDA
Diacomit	stiripentol	powder, for suspension, oral	68418-7941NDA
Diacomit	stiripentol	powder, for suspension, oral	68418-7942NDA

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Enquiry

Common questions

Is Biocodex FDA approved?: Biocodex holds 2 FDA-registered establishments across 2 countries. 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 Biocodex's drugs manufactured?: At registered sites in France, the United States. The FDA register lists Beauvais; Bedminster, NJ. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does Biocodex make?: 4 products are listed under Biocodex in the openFDA NDC Directory, most often as capsule; powder, for suspension. 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.