Register entry
- Registered sites
- 4
- Active NDC listings
- 17
- Labeller names
- 4
- Live patents
- 18
- Exclusivities
- 3
- Countries
- 1
- Base
- Japan
Authorisation
Registered operations
Analytical testing4Active ingredient (API) manufacture2Labelling1Finished drug manufacture2Packaging1
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Shionogi Pharma Co., Ltd. | 2-1-3, Kuiseterajima, Amagasaki, Hyogo 660-0813, Japan (JPN) | Analytical testing | 3006396183717959197 |
| Shionogi Pharma Co., Ltd. | 7, Moriyama, Nishine, Kanegasaki-cho, Isawa-gun, Iwate 029-4503, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002808135717959195 |
| Shionogi Pharma Co., Ltd. | 2-5-1, Mishima, Settsu, Osaka 566-0022, Japan (JPN) | Analytical testing, Finished drug manufacture | 3004544937717855640 |
| Shionogi Pharma Co., Ltd. | 224-20, Hiraishiebisuno, Kawauchicho, Tokushima, Tokushima 771-0132, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture | 3008353674717959194 |
Catalogue
Drug listings by form and route
1717 active NDC listings: 7 human prescription drug, 6 bulk ingredient, 4 drug for further processing. By marketing category: NDA 7, BULK INGREDIENT 6, DRUG FOR FURTHER PROCESSING 4.
| Dosage form | NDCs |
|---|---|
| powder | 6 |
| tablet, coated | 3 |
| kit | 2 |
| solution | 2 |
| granule, for suspension | 1 |
| injection, powder, for solution | 1 |
| tablet | 1 |
| tablet, film coated | 1 |
| Route | NDCs |
|---|---|
| oral | 4 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| shionogi pharma co., ltd. | 8 |
| shionogi inc. | 5 |
| shionogi inc. | 3 |
| shionogi pharma co., ltd | 1 |
Exclusivity
Patents and exclusivities
18| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9150546 | XOCOVAensitrelvir | substance, product | Dec 2030 |
| 9238657 | FETROJAcefiderocol sulfate tosylate | substance, product | Nov 2033 |
| 10004750 | FETROJAcefiderocol sulfate tosylate | substance, product | Sept 2035 |
| 9949982 | FETROJAcefiderocol sulfate tosylate | product | Sept 2035 |
| 10987341 | RADICAVA ORSedaravone | product | Nov 2039 |
| 11241416 | RADICAVA ORSedaravone | product | Nov 2039 |
| 11478450 | RADICAVA ORSedaravone | use | Nov 2039 |
| 11826352 | RADICAVA ORSedaravone | product | Nov 2039 |
| 11957660 | RADICAVA ORSedaravone | product | Nov 2039 |
| 12285409 | RADICAVA ORSedaravone | product | Nov 2039 |
| 12599586 | RADICAVA ORSedaravone | product | Nov 2039 |
| 12194025 | RADICAVA ORSedaravone | use | Nov 2041 |
| 12310946 | RADICAVA ORSedaravone | use | Nov 2041 |
| 12478611 | RADICAVA ORSedaravone | use | Nov 2041 |
| 12527769 | RADICAVA ORSedaravone | use | Nov 2041 |
| 12569469 | RADICAVA ORSedaravone | use | Nov 2041 |
| 11814368 | XOCOVAensitrelvir | substance, product | May 2042 |
| 12559474 | XOCOVAensitrelvir | substance, product | May 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| FETROJACEFIDEROCOL SULFATE TOSYLATE | GAIN Qualified infectious disease product (GAIN) | Nov 2029 |
| RADICAVA ORSEDARAVONE | ODE-144 Orphan drug | May 2029 |
| XOCOVAENSITRELVIR | NCE New chemical entity | May 2031 |
Catalogue
Marketed products
17| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Baloxavir marboxil | powder | 53044-004BULK INGREDIENT |
| - | Baloxavir marboxil | tablet, coated | 53044-828DRUG FOR FURTHER PROCESSING |
| - | Baloxavir marboxil | granule, for suspension | 53044-836DRUG FOR FURTHER PROCESSING |
| - | Baloxavir marboxil | tablet, coated | 53044-860DRUG FOR FURTHER PROCESSING |
| - | Baloxavir marboxil | tablet, coated | 53044-877DRUG FOR FURTHER PROCESSING |
| - | Cefiderocol Sulfate Tosylate | powder | 53044-005BULK INGREDIENT |
| - | Dolutegravir sodium | powder | 53044-001BULK INGREDIENT |
| Fetroja | Cefiderocol sulfate tosylate | injection, powder, for solution, intravenous | 59630-266NDA |
| - | Lusutrombopag | powder | 53044-003BULK INGREDIENT |
| Methylin | Methylphenidate Hydrochloride | solution, oral | 59630-750NDA |
| Methylin | Methylphenidate Hydrochloride | solution, oral | 59630-755NDA |
| Mulpleta | Lusutrombopag | tablet, film coated, oral | 59630-551NDA |
| - | Naldemedine tosylate | powder | 53044-002BULK INGREDIENT |
| RADICAVA ORS | EDARAVONE | kit | 70510-2321NDA |
| RADICAVA ORS | EDARAVONE | kit | 70510-2322NDA |
| XOCOVA | Ensitrelvir | tablet, oral | 59630-711NDA |
| - | edaravone | powder | 70510-2191BULK INGREDIENT |
Neighbours
Registered in the same town
3- Otsuka America Pharmaceutical, Inc.Tokushima, JPN · 2 sites
- FUJIMOTO CHEMICALS CO., LTD.Amagasaki, JPN
- Otsuka Chemical Co., Ltd.Tokushima, JPN
Compare
Comparable companies in Japan
- Terumo Pharmaceutical Services GmbH4 sites · 12 NDC
- Chugai Pharmaceutical Co., Ltd.3 sites · 13 NDC
- Daiichi Sankyo Europe GmbH3 sites · 11 NDC
- Sumitomo Chemical Company, Limited3 sites · 8 NDC
- Meiji Seika Pharma Co., Ltd.3 sites · 1 NDC
- Otsuka America Pharmaceutical, Inc.6 sites · 62 NDC
- Sumitomo Pharma Co., Ltd.2 sites · 24 NDC
- TAYCA CORPORATION2 sites · 22 NDC
- Hisamitsu Pharmaceutical Co., Inc.2 sites · 16 NDC
- Bushu Pharmaceuticals, Ltd.2 sites · 11 NDC
Enquiry
Common questions
- Is Shionogi Pharma Co., Ltd. FDA approved?
- Shionogi Pharma Co., Ltd. holds 4 FDA-registered establishments 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 Shionogi Pharma Co., Ltd.'s drugs manufactured?
- The FDA register lists Amagasaki; Isawa-gun; Settsu; Tokushima. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Shionogi Pharma Co., Ltd. make?
- 17 products are listed under Shionogi Pharma Co., Ltd. in the openFDA NDC Directory, most often as powder; tablet, coated; kit. 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.