Is ADVANCE ZINCTEK LIMITED FDA approved?

ADVANCE ZINCTEK LIMITED 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 ADVANCE ZINCTEK LIMITED's drugs manufactured?

The FDA register lists Rocklea. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does ADVANCE ZINCTEK LIMITED make?

6 products are listed under ADVANCE ZINCTEK LIMITED in the openFDA NDC Directory, most often as solution; powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

ADVANCE ZINCTEK LIMITED

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 6
Live patents: 0
Countries: 1
Base: Australia

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Advance Zinctek limitedRegistrant: ADVANCE ZINCTEK LIMITED	1821 Ipswich Road, Rocklea, QUEENSLAND 4106, Australia (AUS)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3025978151743874997

Catalogue

Drug listings by form and route

6 active NDC listings: 6 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 6.

Dosage form	NDCs
solution	5
powder	1

Route	NDCs

Labeller name on the listing	NDCs
advance zinctek limited	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Zinc Oxide	powder	83679-0000DRUG FOR FURTHER PROCESSING
-	Zinc Oxide	solution	83679-1001DRUG FOR FURTHER PROCESSING
-	Zinc Oxide	solution	83679-1002DRUG FOR FURTHER PROCESSING
-	Zinc Oxide	solution	83679-1003DRUG FOR FURTHER PROCESSING
-	Zinc Oxide	solution	83679-1006DRUG FOR FURTHER PROCESSING
-	Zinc Oxide	solution	83679-1010DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is ADVANCE ZINCTEK LIMITED FDA approved?: ADVANCE ZINCTEK LIMITED 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 ADVANCE ZINCTEK LIMITED's drugs manufactured?: The FDA register lists Rocklea. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does ADVANCE ZINCTEK LIMITED make?: 6 products are listed under ADVANCE ZINCTEK LIMITED in the openFDA NDC Directory, most often as solution; powder. 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.