Is Hikma Injectables USA Inc. FDA approved?

Hikma Injectables USA Inc. holds 1 FDA-registered establishment in the United States. 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 Hikma Injectables USA Inc.'s drugs manufactured?

The FDA register lists Dayton, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.

Hikma Injectables USA Inc.

Data as of 16 Aug 2026 · How to read this entry

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

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Hikma Injectables USA Inc.	36 Stults Road, Dayton, New Jersey (NJ) 08810-1540, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3022897129117939054

Neighbours

Registered in the same town

Reliable Healthcare Logistics, LLCDayton, NJ
Aurolife Pharma LLCDayton, NJ
Guardian Drug Company, Inc.Dayton, NJ
Safrel Pharmaceuticals LLCDayton, NJ

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Enquiry

Common questions

Is Hikma Injectables USA Inc. FDA approved?: Hikma Injectables USA Inc. holds 1 FDA-registered establishment in the United States. 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 Hikma Injectables USA Inc.'s drugs manufactured?: The FDA register lists Dayton, NJ. Registered operations: analytical testing, 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.