Is Argenta US Manufacturing LLC FDA approved?

Argenta US Manufacturing LLC holds 4 FDA-registered establishments across 3 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 Argenta US Manufacturing LLC's drugs manufactured?

At registered sites in the United Kingdom, New Zealand, the United States. The FDA register lists Dundee; Auckland; Fort Dodge, IA; Shawnee, KS. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging.

Argenta US Manufacturing LLC

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

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Registered sites: 4
Active NDC listings: 0
Live patents: 0
Countries: 3
Base: United States

Authorisation

Registered operations

Analytical testing4Active ingredient (API) manufacture1Labelling4Finished drug manufacture4Packaging4Relabelling3Repackaging3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Argenta Dundee LimitedRegistrant: Argenta Limited	Kinnoull Road Dunsinane Industrial Estate, Dundee, DD2 3XR, United Kingdom (GBR)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3002792064222283763
Argenta Limited	2 Sterling Avenue Manurewa, Auckland, 2102, New Zealand (NZL)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3005379357593772127
AML Riverside, LlcRegistrant: Argenta Limited	141 Riverside Dr, Fort Dodge, Iowa (IA) 50501, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	1931411089899815
Argenta US Manufacturing LLC	12707 Shawnee Mission Pkwy, Shawnee, Kansas (KS) 66216, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	0001910953119402875

Neighbours

Registered in the same town

AFT Pharmaceuticals US Inc.Auckland, NZL

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Enquiry

Common questions

Is Argenta US Manufacturing LLC FDA approved?: Argenta US Manufacturing LLC holds 4 FDA-registered establishments across 3 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 Argenta US Manufacturing LLC's drugs manufactured?: At registered sites in the United Kingdom, New Zealand, the United States. The FDA register lists Dundee; Auckland; Fort Dodge, IA; Shawnee, KS. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging.

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.