Is ACI Healthcare USA, Inc. FDA approved?

ACI Healthcare USA, 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 ACI Healthcare USA, Inc.'s drugs manufactured?

At registered sites in Bangladesh, the United States. The FDA register lists Narayanganj; Coral Springs, FL. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does ACI Healthcare USA, Inc. make?

19 products are listed under ACI Healthcare USA, Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated, extended release; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

ACI Healthcare USA, Inc.

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

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Registered sites: 2
Active NDC listings: 19
Labeller names: 2
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing2Labelling1Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ACI HealthCare Limited	Sonargaon Museum Gate-1 Road, Treepordi, Sonargaon, Narayanganj, 1440, Bangladesh (BGD)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3015523180731584418
ACI Healthcare USA, Inc.	10100 W Sample Rd Ste 406, Coral Springs, Florida (FL) 33065-3929, United States (USA)	Analytical testing, Finished drug manufacture, Packaging	3013008413080430318

Catalogue

Drug listings by form and route

19 active NDC listings: 19 human prescription drug. By marketing category: ANDA 19.

Dosage form	NDCs
tablet	7
tablet, film coated, extended release	5
tablet, film coated	4
capsule	3

Route	NDCs
oral	19

Labeller name on the listing	NDCs
aci healthcare usa, inc.	17
aci healthcare usa, inc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Azithromycin Dihydrate	Azithromycin Dihydrate	tablet, film coated, oral	71093-174ANDA
Azithromycin Dihydrate	Azithromycin Dihydrate	tablet, film coated, oral	71093-175ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, oral	71093-127ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, oral	71093-128ANDA
Gabapentin	GABAPENTIN	tablet, film coated, oral	71093-111ANDA
Gabapentin	GABAPENTIN	tablet, film coated, oral	71093-112ANDA
Gabapentin	Gabapentin	capsule, oral	71093-120ANDA
Gabapentin	Gabapentin	capsule, oral	71093-121ANDA
Gabapentin	Gabapentin	capsule, oral	71093-122ANDA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	tablet, oral	71093-132ANDA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	tablet, oral	71093-133ANDA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	tablet, oral	71093-134ANDA
Quetiapine Extended Release	Quetiapine	tablet, film coated, extended release, oral	71093-135ANDA
Quetiapine Extended Release	Quetiapine	tablet, film coated, extended release, oral	71093-136ANDA
Quetiapine Extended Release	Quetiapine	tablet, film coated, extended release, oral	71093-137ANDA
Quetiapine Extended Release	Quetiapine	tablet, film coated, extended release, oral	71093-138ANDA
Quetiapine Extended Release	Quetiapine	tablet, film coated, extended release, oral	71093-139ANDA
Zolpidem	Zolpidem Tartrate	tablet, oral	71093-155ANDA
Zolpidem	Zolpidem Tartrate	tablet, oral	71093-156ANDA

Neighbours

Registered in the same town

Locsanity LLCCoral Springs, FL

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Enquiry

Common questions

Is ACI Healthcare USA, Inc. FDA approved?: ACI Healthcare USA, 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 ACI Healthcare USA, Inc.'s drugs manufactured?: At registered sites in Bangladesh, the United States. The FDA register lists Narayanganj; Coral Springs, FL. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does ACI Healthcare USA, Inc. make?: 19 products are listed under ACI Healthcare USA, Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated, extended release; 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.