Register entryShortage reported
- Registered sites
- 3
- Active NDC listings
- 34
- Labeller names
- 2
- Live patents
- 4
- Exclusivities
- 1
- Shortage listings
- 1
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture3Finished drug manufacture2positron emission tomography drug production1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Curium Netherlands B.V.Registrant: Curium US LLC | Westerduinweg 3, Petten, 1755 LE, Netherlands (NLD) | Analytical testing, Active ingredient (API) manufacture | 3002806617402233811 |
| Curium US LLC | 2703 Wagner Place, Maryland Heights, Missouri (MO) 63043, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, positron emission tomography drug production | 1946929557570652 |
| Curium US LLC | 14395 Bergen Boulevard, Noblesville, Indiana (IN) 46060, United States (USA) | Active ingredient (API) manufacture, Finished drug manufacture | 3011400787117470446 |
Alert
Drug shortage listings
1| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Technetium TC-99M Pyrophosphate Kit InjectionMedical Imaging | Technescan PYP, Injection, 11.9 mg/10 mL; 3.2 mg/10 mL (NDC 69945-094-20) | Current | Limited Availability | 27 Dec 20231 Oct 2026 |
Catalogue
Drug listings by form and route
3434 active NDC listings: 30 human prescription drug, 3 bulk ingredient, 1 drug for further processing. By marketing category: NDA 24, ANDA 5, BULK INGREDIENT 3, BLA 1, DRUG FOR FURTHER PROCESSING 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 17 |
| injection, powder, lyophilized, for solution | 4 |
| capsule, gelatin coated | 2 |
| gas | 2 |
| injection | 2 |
| kit | 2 |
| powder | 2 |
| injection, powder, lyophilized, for suspension | 1 |
| liquid | 1 |
| solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 24 |
| respiratory (inhalation) | 3 |
| oral | 2 |
| intraperitoneal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| curium us llc | 33 |
| curium us llc | 1 |
Exclusivity
Patents and exclusivities
4| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10159759 | DETECTNETcopper cu-64 dotatate | use | Aug 2032 |
| 11160888 | DETECTNETcopper cu-64 dotatate | use | Aug 2032 |
| 10383961 | DETECTNETcopper cu-64 dotatate | use | Jul 2033 |
| 12102696 | DETECTNETcopper cu-64 dotatate | product | Sept 2041 |
| Product | Exclusivity | Until |
|---|---|---|
| DETECTNETCOPPER CU-64 DOTATATE | ODE-317 Orphan drug | Sept 2027 |
Catalogue
Marketed products
34| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| BEXLUTRY | LUTETIUM OXODOTREOTIDE LU-177 | injection, intravenous | 69945-177NDA |
| - | DIETHYLENETRIAMINEPENTAACETIC ACID | powder | 69945-273BULK INGREDIENT |
| Detectnet | copper Cu 64 Dotatate | injection, solution, intravenous | 69945-064NDA |
| GALLIUM CITRATE GA-67 | gallium citrate ga-67 | injection, solution, intravenous | 69945-180NDA |
| - | Germanium-68 | liquid | 69945-544DRUG FOR FURTHER PROCESSING |
| Ioflupane I 123 | IOFLUPANE I-123 | injection, solution, intravenous | 69945-166ANDA |
| Kit for the Preparation of Technetium Tc 99m Pentetate | kit for the preparation of technetium tc 99m pentetate | injection, powder, lyophilized, for solution, intravenous, respiratory (inhalation) | 69945-314ANDA |
| OCTREOSCAN | Indium In -111 Pentetreotide | kit | 69945-050NDA |
| - | OXIDRONATE SODIUM | powder | 69945-410BULK INGREDIENT |
| Pulmotech MAA | kit for the preparation of technetium Tc 99m albumin aggregated | injection, powder, lyophilized, for suspension, intraperitoneal, intravenous | 69945-139BLA |
| SODIUM IODIDE I 123 | sodium iodide i 123 | capsule, gelatin coated, oral | 69945-601ANDA |
| SODIUM IODIDE I 123 | sodium iodide i 123 | capsule, gelatin coated, oral | 69945-602ANDA |
| - | Strontium Sr-82 Chloride | solution | 69945-082BULK INGREDIENT |
| THALLOUS CHLORIDE Tl 201 | thallous chloride, Tl 201 | injection, solution, intravenous | 69945-120NDA |
| Technescan HDP | Technetium Tc 99m Oxidronate | injection, powder, lyophilized, for solution, intravenous | 69945-091NDA |
| Technescan MAG3 | Technescan Tc 99m Mertiatide | injection, powder, lyophilized, for solution, intravenous | 69945-096NDA |
| Technescan PYP | Technetium Tc 99m Pyrophosphate | injection, powder, lyophilized, for solution, intravenous | 69945-094NDA |
| Technetium Tc 99m Sestamibi | Technetium Tc 99m Sestamibi | injection, intravenous | 69945-092ANDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-010NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-015NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-020NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-025NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-030NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-035NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-051NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-060NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-075NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-110NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-140NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-160NDA |
| Ultra-Technekow V4 | Technetium Tc-99m | injection, solution, intravenous | 69945-190NDA |
| Ultratag RBC | Kit for the Preparation of Technetium Tc 99m Red Blood Cells | kit | 69945-068NDA |
| Xenon, Xe-133 | Xenon | gas, respiratory (inhalation) | 69945-097NDA |
| Xenon, Xe-133 | Xenon | gas, respiratory (inhalation) | 69945-098NDA |
Neighbours
Registered in the same town
3- Apertus Pharmaceuticals, LLCMaryland Heights, MO
- Buckeye International, Inc.Maryland Heights, MO
- Sentio BioSciences LLCMaryland Heights, MO
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Enquiry
Common questions
- Is Curium US LLC FDA approved?
- Curium US LLC holds 3 FDA-registered establishments across 2 countries. 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 Curium US LLC's drugs manufactured?
- At registered sites in the Netherlands, the United States. The FDA register lists Petten; Maryland Heights, MO; Noblesville, IN. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, positron emission tomography drug production.
- What drugs does Curium US LLC make?
- 34 products are listed under Curium US LLC in the openFDA NDC Directory, most often as injection, solution; injection, powder, lyophilized, for solution; capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Curium US LLC products in shortage?
- 1 presentation is currently listed in the FDA drug shortage database under Curium US LLC, covering Technetium TC-99M Pyrophosphate Kit Injection.
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.