Is Isotopia Molecular Imaging Ltd FDA approved?

Isotopia Molecular Imaging Ltd holds 4 FDA-registered establishments across 2 countries. 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 Isotopia Molecular Imaging Ltd's drugs manufactured?

At registered sites in Israel, the United States. The FDA register lists Modiin-maccabim-reut; Petah Tikva; Yavne; Westfield, IN. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Isotopia Molecular Imaging Ltd make?

1 product is listed under Isotopia Molecular Imaging Ltd in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Isotopia Molecular Imaging Ltd

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

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Registered sites: 4
Active NDC listings: 1
Live patents: 0
Countries: 2
Base: Israel

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture2Labelling1Finished drug manufacture1Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Isotopia Molecular Imaging	8 Hasatat, Modiin-maccabim-reut, 7178106, Israel (ISR)	Packaging	3043237553626601003
ISOTOPIA MOLECULAR IMAGING LTDRegistrant: Isotopia Molecular Imaging Ltd	39 Alexander Yanai, Segula Industrial Park, Petah Tikva, 4927735, Israel (ISR)	Analytical testing, Active ingredient (API) manufacture	3008617129532000994
Isotopia Molecular Imaging	Soreq Nuclear Reseach Center (NRC), Yavne, 8180000, Israel (ISR)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1000234390521895565
Isotopia USA Inc.Registrant: Isotopia Molecular Imaging Ltd	17075 Oak Ridge Rd, Westfield, Indiana (IN) 46074, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3030925937114586107

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Lutetium chloride (Lu 177)	solution	82008-001DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

Expackusa, Inc.Petah Tikva, ISR

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Enquiry

Common questions

Is Isotopia Molecular Imaging Ltd FDA approved?: Isotopia Molecular Imaging Ltd holds 4 FDA-registered establishments across 2 countries. 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 Isotopia Molecular Imaging Ltd's drugs manufactured?: At registered sites in Israel, the United States. The FDA register lists Modiin-maccabim-reut; Petah Tikva; Yavne; Westfield, IN. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Isotopia Molecular Imaging Ltd make?: 1 product is listed under Isotopia Molecular Imaging Ltd in the openFDA NDC Directory, most often as 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.