Register entry
Advanced Accelerator Applications USA, Inc.
- Registered sites
- 4
- Drug products
- 2
- Live patents
- 18
- Countries
- 3
- Base
- Italy
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) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
4| Site | Location | Operations | FEI |
|---|---|---|---|
| Advanced Accelerator Applications (Italy) srl | Colleretto GiacosaItaly | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3010175147 |
| Advanced Accelerator Applications (Italy) S.r.l. | SaluggiaItaly | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3009551251 |
| IDB Holland B.V. | Baarle-NassauNetherlands | Active ingredient (API) manufacture | 3010293768 |
| Advanced Accelerator Applications USA, Inc. | Millburn, NJUnited States | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3012484129 |
Exclusivity
Patents
18Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| LUTATHERA | LUTETIUM LU 177 DOTATATE | Jul 2038 |
| LUTATHERA | LUTETIUM LU 177 DOTATATE | Jan 2039 |
Catalogue
Marketed products
2Showing 2 of 2.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Lutathera | Lutetium Lu 177 dotatate | INJECTION | NDA |
| NETSPOT | 68Ga-DOTATATE | KIT | 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.