Is Abeona Therapeutics Inc. FDA approved?

Abeona Therapeutics Inc. 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 Abeona Therapeutics Inc.'s drugs manufactured?

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

What drugs does Abeona Therapeutics Inc. make?

1 product is listed under Abeona Therapeutics Inc. in the openFDA NDC Directory, most often as cellular sheet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Abeona Therapeutics Inc.

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: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Abeona Therapeutics Inc.	6555 Carnegie Ave. 4th Floor, Cleveland, Ohio (OH) 44103, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3008334517010614386

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ZEVASKYN	prademagene zamikeracel	cellular sheet, topical	84103-007BLA

Neighbours

Registered in the same town

PETNET Solutions, Inc.CLEVELAND, OH · 2 sites
Charles River Laboratories, Inc.Cleveland, OH
REESE CONSUMER HEALTH CORPORATIONCleveland, OH

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Enquiry

Common questions

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