Register entry
Shandong Luye Pharmaceutical Co LTD
- Registered sites
- 1
- Drug products
- 9
- Live patents
- 20
- Countries
- 1
- Base
- China
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Shandong Luye Pharmaceutical Co., LTD. | YantaiChina | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004330858 |
Exclusivity
Patents
20Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| RYKINDO | RISPERIDONE | Apr 2032 |
Catalogue
Marketed products
9Showing 9 of 9.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Erzofri extended-release | paliperidone palmitate | INJECTION | NDA |
| Erzofri extended-release | paliperidone palmitate | INJECTION | NDA |
| Erzofri extended-release | paliperidone palmitate | INJECTION | NDA |
| Erzofri extended-release | paliperidone palmitate | INJECTION | NDA |
| Erzofri extended-release | paliperidone palmitate | INJECTION | NDA |
| Erzofri extended-release | paliperidone palmitate | INJECTION | NDA |
| Rykindo extended-release microspheres | Risperidone | KIT | NDA |
| Rykindo extended-release microspheres | Risperidone | KIT | NDA |
| Rykindo extended-release microspheres | Risperidone | KIT | 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.