Is Cambridge Isotope Laboratories, Inc. FDA approved?

Cambridge Isotope Laboratories, Inc. holds 3 FDA-registered establishments 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 Cambridge Isotope Laboratories, Inc.'s drugs manufactured?

The FDA register lists Andover, MA; Tewksbury, MA; Xenia, OH. Registered operations: active ingredient (API) manufacture.

What drugs does Cambridge Isotope Laboratories, Inc. make?

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

Cambridge Isotope Laboratories, Inc.

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

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Registered sites: 3
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Active ingredient (API) manufacture3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Cambridge Isotope Laboratories, Inc.	50 Frontage Road, Andover, Massachusetts (MA) 01810, United States (USA)	Active ingredient (API) manufacture	1000513287079242811
Cambridge Isotope Laboratories, Inc.	3 Highwood Drive, Tewksbury, Massachusetts (MA) 01876, United States (USA)	Active ingredient (API) manufacture	3010827078011759875
CIL Isotope Separations, LLCRegistrant: Cambridge Isotope Laboratories, Inc.	1689 Burnett Drive, Xenia, Ohio (OH) 45385, United States (USA)	Active ingredient (API) manufacture	3008934532180544876

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	UREA C-13	powder, for solution	61444-901BULK INGREDIENT

Neighbours

Registered in the same town

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Andover, MA
Sarepta Therapeutics IncAndover, MA

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Enquiry

Common questions

Is Cambridge Isotope Laboratories, Inc. FDA approved?: Cambridge Isotope Laboratories, Inc. holds 3 FDA-registered establishments 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 Cambridge Isotope Laboratories, Inc.'s drugs manufactured?: The FDA register lists Andover, MA; Tewksbury, MA; Xenia, OH. Registered operations: active ingredient (API) manufacture.
What drugs does Cambridge Isotope Laboratories, Inc. make?: 1 product is listed under Cambridge Isotope Laboratories, Inc. in the openFDA NDC Directory, most often as powder, for solution. 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.