Register entry
- Registered sites
- 3
- Active NDC listings
- 11
- Labeller names
- 2
- Live patents
- 52
- Exclusivities
- 2
- Countries
- 2
- Base
- Japan
Authorisation
Registered operations
Analytical testing3Active ingredient (API) manufacture1Labelling1Finished drug manufacture2Packaging1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Daiichi Sankyo Europe GmbH | Luitpoldstr. 1, Pfaffenhofen a.d.Ilm, Bayern 85276, Germany (DEU) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003282622551338593 |
| Daiichi Sankyo Co., Ltd.Registrant: Daiichi Sankyo Co., Ltd | 389-4, Otsurugi, Izumimachishimogawa, Iwaki, Fukushima 971-8183, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture | 3002808054692602767 |
| Daiichi Sankyo Co., Ltd.Registrant: Daiichi Sankyo Co., Ltd | 1-12-1 Shinomiya, Hiratsuka, Kanagawa, 254-0014, Japan (JPN) | Analytical testing, Finished drug manufacture | 3002808070714846367 |
Catalogue
Drug listings by form and route
1111 active NDC listings: 8 human prescription drug, 3 drug for further processing. By marketing category: NDA 6, DRUG FOR FURTHER PROCESSING 3, BLA 2.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 8 |
| injection, powder, lyophilized, for solution | 2 |
| capsule | 1 |
| Route | NDCs |
|---|---|
| oral | 6 |
| intravenous | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| daiichi sankyo inc. | 8 |
| daiichi sankyo europe gmbh | 3 |
Exclusivity
Patents and exclusivities
52| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8129374 | VANFLYTAquizartinib dihydrochloride | use | Mar 2027 |
| 8557810 | VANFLYTAquizartinib dihydrochloride | product | Mar 2027 |
| 8883783 | VANFLYTAquizartinib dihydrochloride | substance | Mar 2027 |
| 9585892 | VANFLYTAquizartinib dihydrochloride | use | Mar 2027 |
| 7365205 | SAVAYSAedoxaban tosylate | substance | Apr 2027 |
| 8404700 | TURALIOpexidartinib hydrochloride | substance | Nov 2027 |
| 8722702 | TURALIOpexidartinib hydrochloride | substance | Nov 2027 |
| 9169250 | TURALIOpexidartinib hydrochloride | substance | Nov 2027 |
| 9149532 | SAVAYSAedoxaban tosylate | product | Mar 2028 |
| 8461169 | TURALIOpexidartinib hydrochloride | use | Apr 2028 |
| 7820657 | VANFLYTAquizartinib dihydrochloride | substance | Sept 2028 |
| 7968543 | VANFLYTAquizartinib dihydrochloride | product | Aug 2029 |
| 8865710 | VANFLYTAquizartinib dihydrochloride | product | Aug 2029 |
| 8836218 | VANFLYTAquizartinib dihydrochloride | use | Mar 2030 |
| 9555040 | VANFLYTAquizartinib dihydrochloride | use | May 2030 |
| 8357690 | VANFLYTAquizartinib dihydrochloride | use | Feb 2031 |
| 7893075 | TURALIOpexidartinib hydrochloride | substance | May 2033 |
| 9358235 | TURALIOpexidartinib hydrochloride | use | Jun 2033 |
| 9675549 | VANFLYTAquizartinib dihydrochloride | product | Sept 2033 |
| 10189833 | TURALIOpexidartinib hydrochloride | use | May 2036 |
| 10730876 | TURALIOpexidartinib hydrochloride | substance | May 2036 |
| 9802932 | TURALIOpexidartinib hydrochloride | substance | May 2036 |
| 10435404 | TURALIOpexidartinib hydrochloride | product | Jul 2038 |
| 10941142 | TURALIOpexidartinib hydrochloride | product | Jul 2038 |
| 10961240 | TURALIOpexidartinib hydrochloride | use | Jul 2038 |
| Product | Exclusivity | Until |
|---|---|---|
| SAVAYSAEDOXABAN TOSYLATE | M-14 Miscellaneous | Oct 2026 |
| VANFLYTAQUIZARTINIB DIHYDROCHLORIDE | ODE-437 Orphan drug | Jul 2030 |
Catalogue
Marketed products
11| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| DATROWAY | Datopotamab Deruxtecan | injection, powder, lyophilized, for solution, intravenous | 65597-801BLA |
| - | EDOXABAN TOSYLATE | tablet, film coated | 66003-201DRUG FOR FURTHER PROCESSING |
| - | EDOXABAN TOSYLATE | tablet, film coated | 66003-202DRUG FOR FURTHER PROCESSING |
| - | EDOXABAN TOSYLATE | tablet, film coated | 66003-203DRUG FOR FURTHER PROCESSING |
| Enhertu | fam-trastuzumab deruxtecan-nxki | injection, powder, lyophilized, for solution, intravenous | 65597-406BLA |
| SAVAYSA | EDOXABAN TOSYLATE | tablet, film coated, oral | 65597-201NDA |
| SAVAYSA | EDOXABAN TOSYLATE | tablet, film coated, oral | 65597-202NDA |
| SAVAYSA | EDOXABAN TOSYLATE | tablet, film coated, oral | 65597-203NDA |
| Turalio | pexidartinib hydrochloride | capsule, oral | 65597-407NDA |
| VANFLYTA | QUIZARTINIB | tablet, film coated, oral | 65597-504NDA |
| VANFLYTA | QUIZARTINIB | tablet, film coated, oral | 65597-511NDA |
Neighbours
Registered in the same town
2- Sakai Chemical Industry Co., Ltd.IWAKI, JPN
- Yuki Gosei Kogyo Co., Ltd.IWAKI, JPN
Compare
Comparable companies in Japan
- Chugai Pharmaceutical Co., Ltd.3 sites · 13 NDC
- Sumitomo Chemical Company, Limited3 sites · 8 NDC
- Meiji Seika Pharma Co., Ltd.3 sites · 1 NDC
- Sumitomo Pharma Co., Ltd.2 sites · 24 NDC
- TAYCA CORPORATION2 sites · 22 NDC
- Shionogi Pharma Co., Ltd.4 sites · 17 NDC
- Hisamitsu Pharmaceutical Co., Inc.2 sites · 16 NDC
- Terumo Pharmaceutical Services GmbH4 sites · 12 NDC
- Bushu Pharmaceuticals, Ltd.2 sites · 11 NDC
- ASO Pharmaceutical Co. Ltd.2 sites · 10 NDC
Enquiry
Common questions
- Is Daiichi Sankyo Europe GmbH FDA approved?
- Daiichi Sankyo Europe GmbH holds 3 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 Daiichi Sankyo Europe GmbH's drugs manufactured?
- At registered sites in Germany, Japan. The FDA register lists Pfaffenhofen a.d.Ilm; Iwaki; Kanagawa. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Daiichi Sankyo Europe GmbH make?
- 11 products are listed under Daiichi Sankyo Europe GmbH in the openFDA NDC Directory, most often as tablet, film coated; injection, powder, lyophilized, for solution; capsule. 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.