Is Autolus Inc. FDA approved?

Autolus Inc. holds 1 FDA-registered establishment in the United Kingdom. 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 Autolus Inc.'s drugs manufactured?

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

What drugs does Autolus Inc. make?

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

Autolus 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 Kingdom

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Autolus LimitedRegistrant: Autolus Inc.	Marshgate, Stevenage, Hertfordshire SG1 1FR, United Kingdom (GBR)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3015674982229442484

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AUCATZYL	Obecabtagene autoleucel	kit	83047-410BLA

Neighbours

Registered in the same town

GlaxoSmithKline Biologicals SAStevenage, GBR

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Enquiry

Common questions

Is Autolus Inc. FDA approved?: Autolus Inc. holds 1 FDA-registered establishment in the United Kingdom. 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 Autolus Inc.'s drugs manufactured?: The FDA register lists Stevenage. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Autolus Inc. make?: 1 product is listed under Autolus Inc. in the openFDA NDC Directory, most often as kit. 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.