Register entry
- Registered sites
- 1
- Active NDC listings
- 2
- Live patents
- 0
- Countries
- 1
- Base
- Israel
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Protalix Ltd | 2 Snunit St. Science Park, POB 455, Carmiel, 2161401, Israel (ISR) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3008289067600721419 |
Catalogue
Drug listings by form and route
22 active NDC listings: 1 bulk ingredient, 1 drug for further processing. By marketing category: BULK INGREDIENT 1, DRUG FOR FURTHER PROCESSING 1.
| Dosage form | NDCs |
|---|---|
| injection, powder, for solution | 1 |
| liquid | 1 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| protalix ltd | 2 |
Catalogue
Marketed products
2| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Taliglucerase alfa | injection, powder, for solution | 50210-248BULK INGREDIENT |
| - | Taliglucerase alfa | liquid | 50210-249DRUG FOR FURTHER PROCESSING |
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Enquiry
Common questions
- Is Protalix Ltd FDA approved?
- Protalix 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 Protalix Ltd's drugs manufactured?
- The FDA register lists Carmiel. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Protalix Ltd make?
- 2 products are listed under Protalix Ltd in the openFDA NDC Directory, most often as injection, powder, for 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.