Register entry
- Registered sites
- 2
- Active NDC listings
- 2
- Live patents
- 9
- Exclusivities
- 1
- Countries
- 1
- Base
- Israel
Authorisation
Registered operations
Analytical testing1Labelling2Finished drug manufacture2Packaging2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Dexcel Ltd. | 1 Dexcel, Or Akiva, 3060000, Israel (ISR) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002806801600534200 |
| Dexcel Pharma Technologies - Yokneam FactoryRegistrant: Dexcel Ltd. | 10 Hakidma, Yokneam Illit, 2069200, Israel (ISR) | Labelling, Finished drug manufacture, Packaging | 3008404887533597626 |
Catalogue
Drug listings by form and route
22 active NDC listings: 2 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 2.
| Dosage form | NDCs |
|---|---|
| tablet, delayed release | 2 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| dexcel pharma technologies ltd. | 2 |
Exclusivity
Patents and exclusivities
9| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 12599565 | OMEPRAZOLEomeprazole | product | Jan 2030 |
| 11077055 | LANSOPRAZOLElansoprazole | product | Apr 2036 |
| 11986554 | LANSOPRAZOLElansoprazole | product | Apr 2036 |
| 10076494 | ESOMEPRAZOLE MAGNESIUM, OMEPRAZOLEesomeprazole magnesium; omeprazole | product | Dec 2036 |
| 10835488 | ESOMEPRAZOLE MAGNESIUM, OMEPRAZOLEesomeprazole magnesium; omeprazole | product | Dec 2036 |
| 10537585 | HEMADYdexamethasone | product | Dec 2037 |
| 11304961 | HEMADYdexamethasone | product | Dec 2037 |
| Product | Exclusivity | Until |
|---|---|---|
| HEMADYDEXAMETHASONE | ODE-271 Orphan drug | Oct 2026 |
Catalogue
Marketed products
2| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Omeprazole | tablet, delayed release | 64239-303DRUG FOR FURTHER PROCESSING |
| - | Omeprazole | tablet, delayed release | 64239-399DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
1- Anna Lotan Ltd.Or Akiva, ISR
Compare
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- Anna Lotan Ltd.1 site · 12 NDC
- Kamada Ltd.1 site · 5 NDC
- Rafa Laboratories Ltd.1 site · 4 NDC
- Gamida Cell LTD1 site · 2 NDC
Enquiry
Common questions
- Is Dexcel Ltd. FDA approved?
- Dexcel Ltd. holds 2 FDA-registered establishments in Israel. 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 Dexcel Ltd.'s drugs manufactured?
- The FDA register lists Or Akiva; Yokneam Illit. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Dexcel Ltd. make?
- 2 products are listed under Dexcel Ltd. in the openFDA NDC Directory, most often as tablet, delayed release. 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.