Is Henogen FDA approved?

Henogen 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 Henogen's drugs manufactured?

The FDA register lists Seneffe. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Henogen make?

1 product is listed under Henogen in the openFDA NDC Directory, most often as injection, suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Henogen

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

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

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Henogen	Rue de la Marlette, 14, Seneffe, 7180, Belgium (BEL)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3005932318371117134

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	lovo-cel Lyfgenia	injection, suspension	84146-0001DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is Henogen FDA approved?: Henogen 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 Henogen's drugs manufactured?: The FDA register lists Seneffe. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Henogen make?: 1 product is listed under Henogen in the openFDA NDC Directory, most often as injection, 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.