Register entry
- Registered sites
- 1
- Active NDC listings
- 2
- Live patents
- 0
- Countries
- 1
- Base
- Israel
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Gamida Cell LTD | Leshem 12, Kiryat Gat, 8258412, Israel (ISR) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3017482905532501574 |
Catalogue
Drug listings by form and route
22 active NDC listings: 1 cellular therapy, 1 human prescription drug. By marketing category: BLA 1, NDA 1.
| Dosage form | NDCs |
|---|---|
| injection, powder, lyophilized, for solution | 1 |
| kit | 1 |
| Route | NDCs |
|---|---|
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| gamida cell inc. | 2 |
Catalogue
Marketed products
2| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| APHEXDA | MOTIXAFORTIDE | injection, powder, lyophilized, for solution, subcutaneous | 73441-062NDA |
| OMISIRGE | omidubicel-onlv | kit | 73441-800BLA |
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Enquiry
Common questions
- Is Gamida Cell LTD FDA approved?
- Gamida Cell LTD holds 1 FDA-registered establishment 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 Gamida Cell LTD's drugs manufactured?
- The FDA register lists Kiryat Gat. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Gamida Cell LTD make?
- 2 products are listed under Gamida Cell LTD in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; 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.