Is Kowa Pharmaceuticals America FDA approved?

Kowa Pharmaceuticals America 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 Kowa Pharmaceuticals America's drugs manufactured?

At registered sites in Japan, the United States. The FDA register lists Nagoya; Montgomery, AL. Registered operations: analytical testing, finished drug manufacture.

What drugs does Kowa Pharmaceuticals America make?

3 products are listed under Kowa Pharmaceuticals America 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.

Kowa Pharmaceuticals America

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

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Registered sites: 2
Active NDC listings: 3
Live patents: 7
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Kowa Company, Ltd.	2-18-57, Hatooka, Kita-ku, Nagoya, AICHI 462-0024, Japan (JPN)	Analytical testing, Finished drug manufacture	3007065180717190628
Kowa Pharmaceuticals America	530 Industrial Park Blvd, Montgomery, Alabama (AL) 36117, United States (USA)	Finished drug manufacture	2014143570119459589

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.

Dosage form	NDCs
tablet, film coated	3

Route	NDCs
oral	3

Labeller name on the listing	NDCs
kowa pharmaceuticals america, inc.	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10238668	SEGLENTIScelecoxib; tramadol hydrochloride	substance, product	Apr 2030
10245276	SEGLENTIScelecoxib; tramadol hydrochloride	substance, product	Apr 2030
10548909	SEGLENTIScelecoxib; tramadol hydrochloride	use	Apr 2030
11478488	SEGLENTIScelecoxib; tramadol hydrochloride	use	Apr 2030
8598152	SEGLENTIScelecoxib; tramadol hydrochloride	substance, product	Apr 2030
9012440	SEGLENTIScelecoxib; tramadol hydrochloride	substance, product	Apr 2030
8846744	SEGLENTIScelecoxib; tramadol hydrochloride	product	Jun 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Livalo	pitavastatin calcium	tablet, film coated, oral	66869-104NDA
Livalo	pitavastatin calcium	tablet, film coated, oral	66869-204NDA
Livalo	pitavastatin calcium	tablet, film coated, oral	66869-404NDA

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Enquiry

Common questions

Is Kowa Pharmaceuticals America FDA approved?: Kowa Pharmaceuticals America 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 Kowa Pharmaceuticals America's drugs manufactured?: At registered sites in Japan, the United States. The FDA register lists Nagoya; Montgomery, AL. Registered operations: analytical testing, finished drug manufacture.
What drugs does Kowa Pharmaceuticals America make?: 3 products are listed under Kowa Pharmaceuticals America 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.