Is REGENXBIO Inc. FDA approved?

REGENXBIO 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 REGENXBIO Inc.'s drugs manufactured?

The FDA register lists Rockville, MD. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

REGENXBIO Inc.

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

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

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
REGENXBIO Inc.	9804 Medical Center Drive, Rockville, Maryland (MD) 20850, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3012957259829689608

Neighbours

Registered in the same town

Sigma-Aldrich CorporationRockville, MD
Bora Pharmaceutical Laboratories Inc.Rockville, MD
Samsung Biologics Co., Ltd.Rockville, MD
Aurinia Pharma U.S., Inc.Rockville, MD
Supernus Pharmaceuticals IncRockville, MD

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Enquiry

Common questions

Is REGENXBIO Inc. FDA approved?: REGENXBIO 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 REGENXBIO Inc.'s drugs manufactured?: The FDA register lists Rockville, MD. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

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.