Is ANSTO FDA approved?

ANSTO holds 1 FDA-registered establishment in Australia. 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 ANSTO's drugs manufactured?

The FDA register lists Lucas Heights. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does ANSTO make?

1 product is listed under ANSTO 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.

ANSTO

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: Australia

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ANSTO	New Illawarra Road, Lucas Heights, New South Wales 2234, Australia (AUS)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3002724726750911232

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	SODIUM MOLYBDATE	solution	51858-001DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is ANSTO FDA approved?: ANSTO holds 1 FDA-registered establishment in Australia. 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 ANSTO's drugs manufactured?: The FDA register lists Lucas Heights. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does ANSTO make?: 1 product is listed under ANSTO 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.