Is Esteve CDMO US, Inc. dba Regis Chemical Company FDA approved?

Esteve CDMO US, Inc. dba Regis Chemical Company 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 Esteve CDMO US, Inc. dba Regis Chemical Company's drugs manufactured?

The FDA register lists Morton Grove, IL. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does Esteve CDMO US, Inc. dba Regis Chemical Company make?

4 products are listed under Esteve CDMO US, Inc. dba Regis Chemical Company 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.

Esteve CDMO US, Inc. dba Regis Chemical Company

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: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Esteve CDMO US, Inc. dba Regis Chemical Company	8210 Austin Avenue, Morton Grove, Illinois (IL) 60053, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	1416120005065594

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
esteve cdmo us, inc.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	ACETAZOLAMIDE	powder	12817-363BULK INGREDIENT
-	BROMFENAC SODIUM	powder	12817-990BULK INGREDIENT
-	DALFAMPRIDINE	powder	12817-054BULK INGREDIENT
-	LEVOKETOCONAZOLE	powder	12817-311BULK INGREDIENT

Neighbours

Registered in the same town

Fareva Morton Grove IncMorton Grove, IL

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Enquiry

Common questions

Is Esteve CDMO US, Inc. dba Regis Chemical Company FDA approved?: Esteve CDMO US, Inc. dba Regis Chemical Company 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 Esteve CDMO US, Inc. dba Regis Chemical Company's drugs manufactured?: The FDA register lists Morton Grove, IL. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does Esteve CDMO US, Inc. dba Regis Chemical Company make?: 4 products are listed under Esteve CDMO US, Inc. dba Regis Chemical Company 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.