Is Phytex Australia Pty Ltd FDA approved?

Phytex Australia 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 Phytex Australia Pty Ltd's drugs manufactured?

The FDA register lists Peakhurst. Registered operations: active ingredient (API) manufacture.

What drugs does Phytex Australia Pty Ltd make?

4 products are listed under Phytex Australia Pty Ltd in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Phytex Australia Pty Ltd

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Phytex Australia Pty Ltd	6 Norman St, Peakhurst, NSW 2210, Australia (AUS)	Active ingredient (API) manufacture	3002807955750984726

Catalogue

Drug listings by form and route

4 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT 4.

Dosage form	NDCs
powder	4

Route	NDCs

Labeller name on the listing	NDCs
phytex australia pty ltd	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Castanospermine	powder	51886-1001BULK INGREDIENT
-	Methscopolamine Bromide	powder	51886-0301BULK INGREDIENT
-	Scopolamine	powder	51886-0501BULK INGREDIENT
-	Scopolamine Hydrobromide	powder	51886-0101BULK INGREDIENT

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Common questions

Is Phytex Australia Pty Ltd FDA approved?: Phytex Australia 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 Phytex Australia Pty Ltd's drugs manufactured?: The FDA register lists Peakhurst. Registered operations: active ingredient (API) manufacture.
What drugs does Phytex Australia Pty Ltd make?: 4 products are listed under Phytex Australia Pty Ltd in the openFDA NDC Directory, most often as 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.