Is Genvion Corporation FDA approved?

Genvion Corporation holds 1 FDA-registered establishment in Canada. 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 Genvion Corporation's drugs manufactured?

The FDA register lists Winnipeg. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, particle size reduction, relabelling, repackaging.

What drugs does Genvion Corporation make?

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

Genvion Corporation

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

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Registered sites: 1
Active NDC listings: 4
Live patents: 0
Countries: 1
Base: Canada

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1particle size reduction1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Genvion Corporation	500 Camiel Sys Street, Winnipeg, Manitoba R2J 4K2, Canada (CAN)	Analytical testing, Labelling, Finished drug manufacture, Packaging, particle size reduction, Relabelling, Repackaging	3010164251245221226

Catalogue

Drug listings by form and route

4 active NDC listings: 3 bulk ingredient, 1 human prescription drug. By marketing category: BULK INGREDIENT 3, ANDA 1.

Dosage form	NDCs
powder	3
tablet	1

Route	NDCs
oral	1

Labeller name on the listing	NDCs
genvion corporation	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cladribine	Cladribine	tablet, oral	62049-286ANDA
-	FLUOROURACIL	powder	62049-185BULK INGREDIENT
-	HYDROXYUREA	powder	62049-135BULK INGREDIENT
-	TRETINOIN	powder	62049-003BULK INGREDIENT

Neighbours

Registered in the same town

Emergent BioSolutions Inc.Winnipeg, CAN

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Enquiry

Common questions

Is Genvion Corporation FDA approved?: Genvion Corporation holds 1 FDA-registered establishment in Canada. 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 Genvion Corporation's drugs manufactured?: The FDA register lists Winnipeg. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, particle size reduction, relabelling, repackaging.
What drugs does Genvion Corporation make?: 4 products are listed under Genvion Corporation in the openFDA NDC Directory, most often as powder; tablet. 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.