Register entry
- Registered sites
- 1
- Active NDC listings
- 12
- Labeller names
- 2
- Live patents
- 29
- Exclusivities
- 3
- Countries
- 1
- Base
- China
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| BeOne Pharmaceutical (Suzhou) Co., Ltd. (Jinhai Road)Registrant: BEONE MEDICINES USA, INC. | No. 29 Jinhai Road, Suzhou Industrial Park China (Jiangsu) Pilot Free Trade Zone, Suzhou Area, Suzhou, Jiangsu 215125, China (CHN) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3014150588576503525 |
Catalogue
Drug listings by form and route
1212 active NDC listings: 9 human prescription drug, 2 drug for further processing, 1 human otc drug. By marketing category: NDA 7, BLA 2, DRUG FOR FURTHER PROCESSING 2, OTC MONOGRAPH DRUG 1.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 7 |
| injection, solution, concentrate | 2 |
| capsule | 1 |
| kit | 1 |
| patch | 1 |
| Route | NDCs |
|---|---|
| oral | 6 |
| intravenous | 2 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| beone medicines usa, inc. | 11 |
| beone co., ltd. | 1 |
Exclusivity
Patents and exclusivities
29| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10570139 | BRUKINSAzanubrutinib | use | Apr 2034 |
| 11142528 | BRUKINSAzanubrutinib | product | Apr 2034 |
| 9447106 | BRUKINSAzanubrutinib | substance, product | Apr 2034 |
| 10927117 | BRUKINSAzanubrutinib | substance, product | Aug 2037 |
| 11591340 | BRUKINSAzanubrutinib | use | Aug 2037 |
| 11851437 | BRUKINSAzanubrutinib | substance, product | Aug 2037 |
| 11884674 | BRUKINSAzanubrutinib | use | Aug 2037 |
| 11970500 | BRUKINSAzanubrutinib | use | Aug 2037 |
| 11420968 | BEQALZIsonrotoclax | substance, product | Apr 2039 |
| 11701357 | BRUKINSAzanubrutinib | use | Jun 2039 |
| 12233069 | BRUKINSAzanubrutinib | product | Jun 2040 |
| 11786531 | BRUKINSAzanubrutinib | use | Jan 2043 |
| 11896596 | BRUKINSAzanubrutinib | use | Jan 2043 |
| 11911386 | BRUKINSAzanubrutinib | use | Jan 2043 |
| Product | Exclusivity | Until |
|---|---|---|
| BEQALZISONROTOCLAX | NCE New chemical entity | May 2031 |
| BRUKINSAZANUBRUTINIB | ODE* Orphan drug | Mar 2031 |
| BRUKINSAZANUBRUTINIB | ODE-467 Orphan drug | Mar 2031 |
Catalogue
Marketed products
13Showing 12 of 13.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| BEQALZI | sonrotoclax | kit | 72579-015NDA |
| BEQALZI | sonrotoclax | tablet, film coated, oral | 72579-017NDA |
| BEQALZI | sonrotoclax | tablet, film coated, oral | 72579-020NDA |
| BEQALZI | sonrotoclax | tablet, film coated, oral | 72579-022NDA |
| BEQALZI | sonrotoclax | tablet, film coated, oral | 72579-025NDA |
| BRUKINSA | zanubrutinib | capsule, oral | 72579-011NDA |
| BRUKINSA | zanubrutinib | tablet, film coated, oral | 72579-122NDA |
| Relief Flex | Menthol | patch, topical | 87379-010OTC MONOGRAPH DRUG |
| TEVIMBRA | tislelizumab-jsgr | injection, solution, concentrate, intravenous | 72579-121BLA |
| TEVIMBRA | tislelizumab-jsgr | injection, solution, concentrate, intravenous | 72579-125BLA |
| - | sonrotoclax | tablet, film coated | 72579-999DRUG FOR FURTHER PROCESSING |
| - | zanubrutinib | tablet, film coated | 72579-901DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
10- WuXi Biologics Co., Ltd.Suzhou, CHN · 4 sites
- BrightGene Bio-Medical Technology Co., Ltd.Suzhou, CHN · 3 sites
- Frontage Laboratories (Suzhou) Co.,Ltd.Suzhou, CHN · 2 sites
- HUTCHMED LimitedSuzhou, CHN
- Advaccine Biologics Suzhou Co., Ltd.Suzhou, CHN
- Anhui Jiuhe Health Industry Co., LtdSuzhou, CHN
- Neutan Pharma (Anhui) Co LtdSuzhou, CHN
- Suzhou Lixin Pharmaceutical Co., Ltd.Suzhou, CHN
- Wugan Pharmaceutical (Suzhou) Co., Ltd.Suzhou, CHN
- Xinyu Pharmaceutical Co., Ltd.SuZhou, CHN
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Enquiry
Common questions
- Is BEONE MEDICINES USA, INC. FDA approved?
- BEONE MEDICINES USA, INC. 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 BEONE MEDICINES USA, INC.'s drugs manufactured?
- The FDA register lists Suzhou. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does BEONE MEDICINES USA, INC. make?
- 13 products are listed under BEONE MEDICINES USA, INC. in the openFDA NDC Directory, most often as tablet, film coated; injection, solution, concentrate; 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.