Register entry
Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Registered sites
- 5
- Drug products
- 11
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackagingpositron emission tomography drug production
Sites
Facilities
5| Site | Location | Operations | FEI |
|---|---|---|---|
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | KirklandCanada | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3009003838 |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | Macon, GAUnited States | positron emission tomography drug production | 3006607900 |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | Mobile, ALUnited States | positron emission tomography drug production | 3006563584 |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | Norcross, GAUnited States | positron emission tomography drug production | 3008754709 |
| Jubilant Draximage (USA) Inc. | Yardley, PAUnited States | Labelling | 3014118270 |
Catalogue
Marketed products
11Showing 11 of 11.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| DRAXIMAGE DTPA | Kit for the preparation of Technetium Tc 99m Pentetate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| DRAXIMAGE MAA | Kit for the preparation of Technetium Tc 99m Albumin aggregated | INJECTION, POWDER, FOR SOLUTION | BLA |
| Drax Exametazime | Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | INJECTION, SOLUTION | ANDA |
| HICON | Sodium Iodide I 131 | SOLUTION | NDA |
| Kit for the Preparation of Technetium Tc 99m Sulfur Colloid | Technetium Tc 99m Sulfur Colloid Kit | KIT | ANDA |
| RUBY-FILL | Rubidium Rb 82 | INJECTION, SOLUTION | NDA |
| Sodium Iodide I 131 Diagnostic | Sodium Iodide I 131 | CAPSULE | NDA |
| TECHNETIUM TC 99M SESTAMIBI | Technetium TC 99m Sestamibi | INJECTION, POWDER, FOR SOLUTION | ANDA |
| TECHNETIUM Tc 99m MERTIATIDE | Technetium Tc 99m Mertiatide | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Technetium Tc 99m Medronate | Technetium Tc 99m Medronate | INJECTION, POWDER, FOR SOLUTION | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.