Is Omya Inc. FDA approved?

Omya 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 Omya Inc.'s drugs manufactured?

The FDA register lists Superior, AZ. Registered operations: active ingredient (API) manufacture.

What drugs does Omya Inc. make?

4 products are listed under Omya Inc. 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.

Omya Inc.

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Omya Inc.	6 N Mesquite Rd, Superior, Arizona (AZ) 85173, United States (USA)	Active ingredient (API) manufacture	3003624292117198571

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
omya inc.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Calcium Carbonate	powder	67054-001BULK INGREDIENT
-	Calcium Carbonate	powder	67054-003BULK INGREDIENT
-	Calcium Carbonate	powder	67054-004BULK INGREDIENT
-	Calcium Carbonate	powder	67054-005BULK INGREDIENT

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Common questions

Is Omya Inc. FDA approved?: Omya 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 Omya Inc.'s drugs manufactured?: The FDA register lists Superior, AZ. Registered operations: active ingredient (API) manufacture.
What drugs does Omya Inc. make?: 4 products are listed under Omya Inc. 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.