Register entryShortage reported
Curium US LLC
- Registered sites
- 3
- Drug products
- 33
- Live patents
- 4
- 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 testingActive ingredient (API) manufactureFinished drug manufacturepositron emission tomography drug production
Sites
Facilities
3| Site | Location | Operations | FEI |
|---|---|---|---|
| Curium Netherlands B.V. | PettenNetherlands | Analytical testing, Active ingredient (API) manufacture | 3002806617 |
| Curium US LLC | Maryland Heights, MOUnited States | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, positron emission tomography drug production | 1946929 |
| Curium US LLC | Noblesville, INUnited States | Active ingredient (API) manufacture, Finished drug manufacture | 3011400787 |
Alert
Products in shortage
1| Drug | Presentation | Availability |
|---|---|---|
| Technetium TC-99M Pyrophosphate Kit Injection | Technescan PYP, Injection, 11.9 mg/10 mL; 3.2 mg/10 mL (NDC 69945-094-20) | Limited Availability |
Exclusivity
Patents
4Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| DETECTNET | COPPER CU-64 DOTATATE | Aug 2032 |
| DETECTNET | COPPER CU-64 DOTATATE | Jul 2033 |
| DETECTNET | COPPER CU-64 DOTATATE | Sept 2041 |
Catalogue
Marketed products
33Showing 33 of 33.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | DIETHYLENETRIAMINEPENTAACETIC ACID | POWDER | BULK INGREDIENT |
| Detectnet | copper Cu 64 Dotatate | INJECTION, SOLUTION | NDA |
| GALLIUM CITRATE GA-67 | gallium citrate ga-67 | INJECTION, SOLUTION | NDA |
| - | Germanium-68 | LIQUID | DRUG FOR FURTHER PROCESSING |
| Ioflupane I 123 | IOFLUPANE I-123 | INJECTION, SOLUTION | ANDA |
| Kit for the Preparation of Technetium Tc 99m Pentetate | kit for the preparation of technetium tc 99m pentetate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| OCTREOSCAN | Indium In -111 Pentetreotide | KIT | NDA |
| - | OXIDRONATE SODIUM | POWDER | BULK INGREDIENT |
| Pulmotech MAA | kit for the preparation of technetium Tc 99m albumin aggregated | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION | BLA |
| SODIUM IODIDE I 123 | sodium iodide i 123 | CAPSULE, GELATIN COATED | ANDA |
| SODIUM IODIDE I 123 | sodium iodide i 123 | CAPSULE, GELATIN COATED | ANDA |
| - | Strontium Sr-82 Chloride | SOLUTION | BULK INGREDIENT |
| THALLOUS CHLORIDE Tl 201 | thallous chloride, Tl 201 | INJECTION, SOLUTION | NDA |
| Technescan HDP | Technetium Tc 99m Oxidronate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Technescan MAG3 | Technescan Tc 99m Mertiatide | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Technescan PYP | Technetium Tc 99m Pyrophosphate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Technetium Tc 99m Sestamibi | Technetium Tc 99m Sestamibi | INJECTION | ANDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | INJECTION, SOLUTION | NDA |
| Ultratag RBC | Kit for the Preparation of Technetium Tc 99m Red Blood Cells | KIT | NDA |
| Xenon, Xe-133 | Xenon | GAS | NDA |
| Xenon, Xe-133 | Xenon | GAS | 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.