Register entry
- Registered sites
- 1
- Active NDC listings
- 11
- Labeller names
- 2
- Live patents
- 4
- Countries
- 1
- Base
- Japan
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Kyowa Kirin Co., Ltd. | 100-1 Hagiwara-machi, Takasaki-shi, Gunma 370-0013, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3007588904713636520 |
Catalogue
Drug listings by form and route
1111 active NDC listings: 7 human prescription drug, 4 drug for further processing. By marketing category: BLA 4, DRUG FOR FURTHER PROCESSING 4, NDA 3.
| Dosage form | NDCs |
|---|---|
| injection | 8 |
| tablet, film coated | 2 |
| tablet | 1 |
| Route | NDCs |
|---|---|
| oral | 3 |
| subcutaneous | 3 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| kyowa kirin, inc. | 7 |
| kyowa kirin co., ltd. | 4 |
Exclusivity
Patents and exclusivities
4| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8318201 | NOURIANZistradefylline | product | Sept 2027 |
| 7727993 | NOURIANZistradefylline | product | Jan 2028 |
Catalogue
Marketed products
11| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| CRYSVITA | Burosumab | injection, subcutaneous | 42747-102BLA |
| CRYSVITA | Burosumab | injection, subcutaneous | 42747-203BLA |
| CRYSVITA | Burosumab | injection, subcutaneous | 42747-304BLA |
| Fareston | toremifene citrate | tablet, oral | 42747-327NDA |
| NOURIANZ | istradefylline | tablet, film coated, oral | 42747-602NDA |
| NOURIANZ | istradefylline | tablet, film coated, oral | 42747-604NDA |
| POTELIGEO | mogamulizumab-kpkc | injection, intravenous | 42747-761BLA |
| - | burosumab | injection | 45793-0101DRUG FOR FURTHER PROCESSING |
| - | burosumab | injection | 45793-0102DRUG FOR FURTHER PROCESSING |
| - | burosumab | injection | 45793-0103DRUG FOR FURTHER PROCESSING |
| - | mogamulizumab | injection | 45793-0201DRUG FOR FURTHER PROCESSING |
Compare
Comparable companies in Japan
- Sato Pharmaceutical Co., Ltd.1 site · 33 NDC
- Sakai Chemical Industry Co., Ltd.1 site · 20 NDC
- KYOWA HAKKO BIO CO., LTD.1 site · 14 NDC
- Titan Kogyo , Ltd.1 site · 8 NDC
- Kyowa Pharma Chemical Co., Ltd.1 site · 6 NDC
- Alps Pharmaceutical Ind. Co., Ltd.1 site · 5 NDC
- Kongo Chemical Co., Ltd.1 site · 5 NDC
- Yuki Gosei Kogyo Co., Ltd.1 site · 5 NDC
- Juzen Chemical Corporation1 site · 4 NDC
- Toshiki Pigment Company Limited1 site · 4 NDC
Enquiry
Common questions
- Is Kyowa Kirin Co., Ltd. FDA approved?
- Kyowa Kirin Co., Ltd. holds 1 FDA-registered establishment in Japan. 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 Kyowa Kirin Co., Ltd.'s drugs manufactured?
- The FDA register lists Takasaki-shi. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Kyowa Kirin Co., Ltd. make?
- 11 products are listed under Kyowa Kirin Co., Ltd. in the openFDA NDC Directory, most often as injection; tablet, film coated; tablet. 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.