Is The Regents of the University of Michigan FDA approved?

The Regents of the University of Michigan 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 The Regents of the University of Michigan's registered sites?

The FDA register lists Ann Arbor, MI. Registered operations: positron emission tomography drug production.

What drugs does The Regents of the University of Michigan make?

1 product is listed under The Regents of the University of Michigan in the openFDA NDC Directory, most often as injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

The Regents of the University of Michigan

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Division of Nuclear Medicine PET Radiopharmaceutical Production ProgramRegistrant: The Regents of the University of Michigan	1301 Catherine Street, 2276 Medical Science Building I, SPC-5610, Ann Arbor, Michigan (MI) 48109, United States (USA)	positron emission tomography drug production	3010166888969869218

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Fludeoxyglucose F18	Fludeoxyglucose F18	injection, intravenous	76326-001ANDA

Neighbours

Registered in the same town

Cayman Chemical Company, Inc.Ann Arbor, MI
POMG INCAnn Arbor, MI

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UIHC-PET Imaging Center1 site · 2 NDC

Enquiry

Common questions

Is The Regents of the University of Michigan FDA approved?: The Regents of the University of Michigan 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 The Regents of the University of Michigan's registered sites?: The FDA register lists Ann Arbor, MI. Registered operations: positron emission tomography drug production.
What drugs does The Regents of the University of Michigan make?: 1 product is listed under The Regents of the University of Michigan in the openFDA NDC Directory, most often as injection. 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.