Register entry
- Registered sites
- 1
- Active NDC listings
- 5
- Live patents
- 0
- Countries
- 1
- Base
- Israel
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Kamada - Production PlantRegistrant: Kamada Ltd. | Kibbutz, Beit Kama, 8532500, Israel (ISR) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 1000630279649062486 |
Catalogue
Drug listings by form and route
55 active NDC listings: 5 plasma derivative. By marketing category: BLA 5.
| Dosage form | NDCs |
|---|---|
| injection, solution | 4 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| intramuscular | 4 |
| intravenous | 4 |
| Labeller name on the listing | NDCs |
|---|---|
| kamada ltd. | 5 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Cytogam | HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN | liquid, intravenous | 49591-532BLA |
| HepaGam B | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN | injection, solution, intramuscular, intravenous | 49591-051BLA |
| HepaGam B | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN | injection, solution, intramuscular, intravenous | 49591-052BLA |
| VARIZIG | HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN | injection, solution, intramuscular | 49591-126BLA |
| WinRho SDF | HUMAN RHO(D) IMMUNE GLOBULIN | injection, solution, intramuscular, intravenous | 49591-330BLA |
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Enquiry
Common questions
- Is Kamada Ltd. FDA approved?
- Kamada 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 Kamada Ltd.'s drugs manufactured?
- The FDA register lists Beit Kama. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Kamada Ltd. make?
- 5 products are listed under Kamada Ltd. in the openFDA NDC Directory, most often as injection, solution; liquid. 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.