Register entry
Kowa Pharmaceuticals America
- Registered sites
- 2
- Drug products
- 3
- Live patents
- 7
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingFinished drug manufacture
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| Kowa Company, Ltd. | NagoyaJapan | Analytical testing, Finished drug manufacture | 3007065180 |
| Kowa Pharmaceuticals America | Montgomery, ALUnited States | Finished drug manufacture | 2014143570 |
Exclusivity
Patents
7Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| SEGLENTIS | CELECOXIB; TRAMADOL HYDROCHLORIDE | Apr 2030 |
| SEGLENTIS | CELECOXIB; TRAMADOL HYDROCHLORIDE | Jun 2031 |
Catalogue
Marketed products
3Showing 3 of 3.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Livalo | pitavastatin calcium | TABLET, FILM COATED | NDA |
| Livalo | pitavastatin calcium | TABLET, FILM COATED | NDA |
| Livalo | pitavastatin calcium | TABLET, FILM COATED | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.