Is Advanced Accelerator Applications USA, Inc. FDA approved?

Advanced Accelerator Applications USA, Inc. holds 4 FDA-registered establishments across 3 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 Advanced Accelerator Applications USA, Inc.'s drugs manufactured?

At registered sites in Italy, the Netherlands, the United States. The FDA register lists Colleretto Giacosa; Saluggia; Baarle-Nassau; Millburn, NJ. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Advanced Accelerator Applications USA, Inc. make?

2 products are listed under Advanced Accelerator Applications USA, Inc. in the openFDA NDC Directory, most often as injection; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Advanced Accelerator Applications USA, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 4
Active NDC listings: 2
Live patents: 18
Exclusivities: 1
Countries: 3
Base: Italy

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture3Labelling3Finished drug manufacture3Packaging3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Advanced Accelerator Applications (Italy) srlRegistrant: Advanced Accelerator Applications USA, Inc.	Via Ribes 5, Colleretto Giacosa, TO 10010, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3010175147516796146
Advanced Accelerator Applications (Italy) S.r.l.Registrant: Advanced Accelerator Applications USA, Inc.	VIA Crescentino snc, Saluggia, 13040, Italy (ITA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3009551251441182729
IDB Holland B.V.Registrant: Advanced Accelerator Applications USA, Inc.	Weverstraat 17, Baarle-Nassau, PV 5111, Netherlands (NLD)	Active ingredient (API) manufacture	3010293768489041640
Advanced Accelerator Applications USA, Inc.	57 East Willow Street, Millburn, New Jersey (NJ) 07041, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3012484129080178357

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
injection	1
kit	1

Route	NDCs
intravenous	2

Labeller name on the listing	NDCs
advanced accelerator applications usa, inc	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10596276	LUTATHERAlutetium lu 177 dotatate	product	Jul 2038
10596278	LUTATHERAlutetium lu 177 dotatate	product	Jul 2038
11904027	LUTATHERAlutetium lu 177 dotatate	product	Jul 2038
12144873	LUTATHERAlutetium lu 177 dotatate	use	Jul 2038
12151003	LUTATHERAlutetium lu 177 dotatate	product	Jul 2038
12161732	LUTATHERAlutetium lu 177 dotatate	product	Jul 2038
12168063	LUTATHERAlutetium lu 177 dotatate	product	Jul 2038
12415003	LUTATHERAlutetium lu 177 dotatate	use	Jul 2038
12491272	LUTATHERAlutetium lu 177 dotatate	use	Jul 2038
10596276*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039
10596278*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039
11904027*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039
12144873*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039
12151003*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039
12161732*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039
12168063*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039
12415003*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039
12491272*PED	LUTATHERAlutetium lu 177 dotatate	use	Jan 2039

Product	Exclusivity	Until
LUTATHERALUTETIUM LU 177 DOTATATE	PED Paediatric	Oct 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Lutathera	Lutetium Lu 177 dotatate	injection, intravenous	69488-003NDA
NETSPOT	68Ga-DOTATATE	kit, intravenous	69488-001NDA

Neighbours

Registered in the same town

EMD Serono, Inc.Colleretto Giacosa, ITA
BRACCO DIAGNOSTICS INCCOLLERETTO GIACOSA, ITA

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Enquiry

Common questions

Is Advanced Accelerator Applications USA, Inc. FDA approved?: Advanced Accelerator Applications USA, Inc. holds 4 FDA-registered establishments across 3 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 Advanced Accelerator Applications USA, Inc.'s drugs manufactured?: At registered sites in Italy, the Netherlands, the United States. The FDA register lists Colleretto Giacosa; Saluggia; Baarle-Nassau; Millburn, NJ. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Advanced Accelerator Applications USA, Inc. make?: 2 products are listed under Advanced Accelerator Applications USA, Inc. in the openFDA NDC Directory, most often as injection; kit. 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.