Register entry
Shandong Luye Pharmaceutical Co LTD
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 9
- Live patents
- 20
- Countries
- 1
- Base
- China
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Shandong Luye Pharmaceutical Co., LTD.Registrant: Shandong Luye Pharmaceutical Co LTD | No.15 Chuangye Road, Hi-tech Industrial Development Zone,, Yantai, Shandong Province 264003, China (CHN) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004330858544705452 |
Catalogue
Drug listings by form and route
99 active NDC listings: 9 human prescription drug. By marketing category: NDA 9.
| Dosage form | NDCs |
|---|---|
| injection | 6 |
| kit | 3 |
| Route | NDCs |
|---|---|
| intramuscular | 6 |
| Labeller name on the listing | NDCs |
|---|---|
| shandong luye pharmaceutical co., ltd. | 9 |
Exclusivity
Patents and exclusivities
20| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10098882 | RYKINDOrisperidone | product | Apr 2032 |
| 10406161 | RYKINDOrisperidone | product | Apr 2032 |
| 11110094 | RYKINDOrisperidone | product | Apr 2032 |
| 9446135 | RYKINDOrisperidone | product | Apr 2032 |
| 9532991 | RYKINDOrisperidone | product | Apr 2032 |
Catalogue
Marketed products
9| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Erzofri extended-release | paliperidone palmitate | injection, intramuscular | 72526-105NDA |
| Erzofri extended-release | paliperidone palmitate | injection, intramuscular | 72526-106NDA |
| Erzofri extended-release | paliperidone palmitate | injection, intramuscular | 72526-107NDA |
| Erzofri extended-release | paliperidone palmitate | injection, intramuscular | 72526-108NDA |
| Erzofri extended-release | paliperidone palmitate | injection, intramuscular | 72526-109NDA |
| Erzofri extended-release | paliperidone palmitate | injection, intramuscular | 72526-110NDA |
| Rykindo extended-release microspheres | Risperidone | kit | 72526-102NDA |
| Rykindo extended-release microspheres | Risperidone | kit | 72526-103NDA |
| Rykindo extended-release microspheres | Risperidone | kit | 72526-104NDA |
Neighbours
Registered in the same town
3- Shandong Boan Biotechnology Co., Ltd.Yantai, CHN · 2 sites
- Yantai Dongcheng Biochemicals Co.,Ltd.Yantai, CHN
- Yantai Dupont Daily Necessities Co., Ltd.Yantai, CHN
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Enquiry
Common questions
- Is Shandong Luye Pharmaceutical Co LTD FDA approved?
- Shandong Luye Pharmaceutical Co LTD holds 1 FDA-registered establishment in China. 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 Shandong Luye Pharmaceutical Co LTD's drugs manufactured?
- The FDA register lists Yantai. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Shandong Luye Pharmaceutical Co LTD make?
- 9 products are listed under Shandong Luye Pharmaceutical Co LTD in the openFDA NDC Directory, most often as injection; 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.