Is Micronisers Australasia Pty. Ltd. FDA approved?

Micronisers Australasia Pty. Ltd. 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 Micronisers Australasia Pty. Ltd.'s drugs manufactured?

The FDA register lists Dandenong South. Registered operations: active ingredient (API) manufacture, particle size reduction.

Micronisers Australasia Pty. Ltd.

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

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Registered sites: 1
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: Australia

Authorisation

Registered operations

Active ingredient (API) manufacture1particle size reduction1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Micronisers Australasia PTY LTDRegistrant: Micronisers Australasia Pty. Ltd.	6-8 England Street, Dandenong South, Victoria 3175, Australia (AUS)	Active ingredient (API) manufacture, particle size reduction	3003991548740185459

Neighbours

Registered in the same town

Eurofins BioPharma Product Testing Australia Pty LtdDandenong South, AUS

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Common questions

Is Micronisers Australasia Pty. Ltd. FDA approved?: Micronisers Australasia Pty. Ltd. 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 Micronisers Australasia Pty. Ltd.'s drugs manufactured?: The FDA register lists Dandenong South. Registered operations: active ingredient (API) manufacture, particle size reduction.

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.