Is AFT Pharmaceuticals US Inc. FDA approved?

AFT Pharmaceuticals US Inc. holds 2 FDA-registered establishments across 2 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 AFT Pharmaceuticals US Inc.'s drugs manufactured?

At registered sites in New Zealand, the United States. The FDA register lists Auckland; Bloomfield Hills, MI. Registered operations: finished drug manufacture.

What drugs does AFT Pharmaceuticals US Inc. make?

1 product is listed under AFT Pharmaceuticals US Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

AFT Pharmaceuticals US Inc.

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

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Registered sites: 2
Active NDC listings: 1
Live patents: 2
Countries: 2
Base: United States

Authorisation

Registered operations

Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
AFT PHARMACEUTICALS LIMITEDRegistrant: AFT Pharmaceuticals Ltd	L 1 129 Hurstmere Rd, Auckland, 0622, New Zealand (NZL)	Finished drug manufacture	3011756349591383294
AFT Pharmaceuticals US, Inc.Registrant: AFT Pharmaceuticals US Inc.	42714 Woodward Avenue, Suite B, Bloomfield Hills, Michigan (MI) 48304, United States (USA)	Finished drug manufacture	3032847224119336103

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11197830	COMBOGESICacetaminophen; ibuprofen	product	Feb 2039
11534407	COMBOGESICacetaminophen; ibuprofen	product	Feb 2039

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Combogesic	ACETAMINOPHEN and IBUPROFEN	tablet, film coated, oral	72260-129NDA

Neighbours

Registered in the same town

Argenta US Manufacturing LLCAuckland, NZL

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Enquiry

Common questions

Is AFT Pharmaceuticals US Inc. FDA approved?: AFT Pharmaceuticals US Inc. holds 2 FDA-registered establishments across 2 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 AFT Pharmaceuticals US Inc.'s drugs manufactured?: At registered sites in New Zealand, the United States. The FDA register lists Auckland; Bloomfield Hills, MI. Registered operations: finished drug manufacture.
What drugs does AFT Pharmaceuticals US Inc. make?: 1 product is listed under AFT Pharmaceuticals US Inc. in the openFDA NDC Directory, most often as tablet, film coated. 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.