Register entry
Shionogi Pharma Co., Ltd.
- Registered sites
- 4
- Drug products
- 17
- Live patents
- 18
- Countries
- 1
- Base
- Japan
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
4| Site | Location | Operations | FEI |
|---|---|---|---|
| Shionogi Pharma Co., Ltd. | AmagasakiJapan | Analytical testing | 3006396183 |
| Shionogi Pharma Co., Ltd. | Isawa-gunJapan | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002808135 |
| Shionogi Pharma Co., Ltd. | SettsuJapan | Analytical testing, Finished drug manufacture | 3004544937 |
| Shionogi Pharma Co., Ltd. | TokushimaJapan | Analytical testing, Active ingredient (API) manufacture | 3008353674 |
Exclusivity
Patents
18Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| FETROJA | CEFIDEROCOL SULFATE TOSYLATE | Nov 2033 |
| FETROJA | CEFIDEROCOL SULFATE TOSYLATE | Sept 2035 |
| RADICAVA ORS | EDARAVONE | Nov 2039 |
| RADICAVA ORS | EDARAVONE | Nov 2041 |
| XOCOVA | ENSITRELVIR | Dec 2030 |
| XOCOVA | ENSITRELVIR | May 2042 |
Catalogue
Marketed products
17Showing 17 of 17.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | Baloxavir marboxil | POWDER | BULK INGREDIENT |
| - | Baloxavir marboxil | TABLET, COATED | DRUG FOR FURTHER PROCESSING |
| - | Baloxavir marboxil | GRANULE, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | Baloxavir marboxil | TABLET, COATED | DRUG FOR FURTHER PROCESSING |
| - | Baloxavir marboxil | TABLET, COATED | DRUG FOR FURTHER PROCESSING |
| - | Cefiderocol Sulfate Tosylate | POWDER | BULK INGREDIENT |
| - | Dolutegravir sodium | POWDER | BULK INGREDIENT |
| Fetroja | Cefiderocol sulfate tosylate | INJECTION, POWDER, FOR SOLUTION | NDA |
| - | Lusutrombopag | POWDER | BULK INGREDIENT |
| Methylin | Methylphenidate Hydrochloride | SOLUTION | NDA |
| Methylin | Methylphenidate Hydrochloride | SOLUTION | NDA |
| Mulpleta | Lusutrombopag | TABLET, FILM COATED | NDA |
| - | Naldemedine tosylate | POWDER | BULK INGREDIENT |
| RADICAVA ORS | EDARAVONE | KIT | NDA |
| RADICAVA ORS | EDARAVONE | KIT | NDA |
| XOCOVA | Ensitrelvir | TABLET | NDA |
| - | edaravone | POWDER | BULK INGREDIENT |
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.