Is Axogen Corporation FDA approved?

Axogen Corporation holds 1 FDA-registered establishment in the United States. 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 Axogen Corporation's drugs manufactured?

The FDA register lists Vandalia, OH. Registered operations: analytical testing, distribute, labelling, finished drug manufacture, packaging.

What drugs does Axogen Corporation make?

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

Axogen Corporation

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 16
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1distribute1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
AxogenRegistrant: Axogen Corporation	913 Industrial Park Dr, Vandalia, Ohio (OH) 45377-3115, United States (USA)	Analytical testing, distribute, Labelling, Finished drug manufacture, Packaging	3023488176077495007

Catalogue

Drug listings by form and route

16 active NDC listings: 16 human prescription drug. By marketing category: BLA 16.

Dosage form	NDCs
implant	16

Route	NDCs
soft tissue	16

Labeller name on the listing	NDCs
axogen corporation	16

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-115BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-130BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-150BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-170BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-215BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-230BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-250BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-270BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-315BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-330BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-350BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-370BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-415BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-430BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-450BLA
Avance Nerve Graft	Processed nerve allograft	implant, soft tissue	84545-470BLA

Neighbours

Registered in the same town

Adare Pharmaceuticals USA, Inc.Vandalia, OH

Compare

Comparable companies in United States

Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals1 site · 4,853 NDC
NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC
Greer Laboratories, Inc.1 site · 1,328 NDC
ASCLEMED USA INC. DBA ENOVACHEM1 site · 789 NDC
Golden State Medical Supply Inc.1 site · 670 NDC
Rising Pharma Holdings, Inc.1 site · 532 NDC
HF Acquisition Co LLC1 site · 363 NDC
ANI Pharmaceuticals, Inc.1 site · 299 NDC
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 site · 273 NDC
Newton Laboratories, Inc.1 site · 271 NDC

Enquiry

Common questions

Is Axogen Corporation FDA approved?: Axogen Corporation holds 1 FDA-registered establishment in the United States. 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 Axogen Corporation's drugs manufactured?: The FDA register lists Vandalia, OH. Registered operations: analytical testing, distribute, labelling, finished drug manufacture, packaging.
What drugs does Axogen Corporation make?: 16 products are listed under Axogen Corporation in the openFDA NDC Directory, most often as implant. 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.