Register entry
- Registered sites
- 6
- Active NDC listings
- 31
- Labeller names
- 3
- Live patents
- 3
- Countries
- 4
- Base
- Italy
Authorisation
Registered operations
Analytical testing4Active ingredient (API) manufacture2Finished drug manufacture4
Sites
Registered establishments
6| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Bracco Suisse SARegistrant: BRACCO DIAGNOSTICS INC | Route de la Galaise 31, Plan-les-Ouates, 1228, Switzerland (CHE) | Analytical testing, Finished drug manufacture | 3002740213485635705 |
| BIPSO GmbHRegistrant: BRACCO DIAGNOSTICS INC | Robert-Gerwig-Str. 4, Singen (Hohentwiel), 78224, Germany (DEU) | Analytical testing, Finished drug manufacture | 3009099058342104149 |
| BRACCO IMAGING SPARegistrant: BRACCO DIAGNOSTICS INC | VIA RIBES 5, COLLERETTO GIACOSA, 10010, Italy (ITA) | Analytical testing, Finished drug manufacture | 3005604782434384008 |
| BRACCO IMAGING SPARegistrant: BRACCO DIAGNOSTICS INC | Via Per Ceriano Laghetto, Ceriano Laghetto, Monza E Brianza 20816, Italy (ITA) | Analytical testing, Active ingredient (API) manufacture | 1000171506434384007 |
| SPIN S.p.A.Registrant: BRACCO DIAGNOSTICS INC | 1, Piazzale Franco Marinotti, Torviscosa, Udine 33050, Italy (ITA) | Active ingredient (API) manufacture | 3019100570434967237 |
| BRACCO DIAGNOSTICS INC | 510 Carnegie Ctr Ste 300, Princeton, New Jersey (NJ) 08540-6905, United States (USA) | Finished drug manufacture | 1000307800849234661 |
Catalogue
Drug listings by form and route
3131 active NDC listings: 31 human prescription drug. By marketing category: NDA 24, UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 7.
| Dosage form | NDCs |
|---|---|
| injection, solution | 21 |
| injection | 5 |
| injection, powder, lyophilized, for solution | 2 |
| injection, powder, lyophilized, for suspension | 1 |
| kit | 1 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| intravenous | 15 |
| intravascular | 11 |
| intra-arterial | 2 |
| intrathecal | 2 |
| intravesical | 2 |
| oral | 1 |
| rectal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| bracco diagnostics inc | 24 |
| bracco diagnostics inc | 6 |
| bracco diagnostics inc. | 1 |
Exclusivity
Patents and exclusivities
3| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10232061 | LUMASONsulfur hexafluoride lipid-type a microspheres | product | Jul 2038 |
| 10335502 | LUMASONsulfur hexafluoride lipid-type a microspheres | product | Jul 2038 |
| 11723869 | LUMASONsulfur hexafluoride lipid-type a microspheres | product | May 2039 |
Catalogue
Marketed products
31| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| CardioGen-82 | Rubidium Chloride RB-82 | injection, solution, intravenous | 0270-0091NDA |
| Choletec | Mebrofenin | injection, powder, lyophilized, for solution, intravenous | 0270-0083NDA |
| Cystografin | diatrizoate meglumine | injection, solution, intravenous | 0270-0149NDA |
| Cystografin Dilute | diatrizoate meglumine | injection, solution, intravesical | 0270-1410NDA |
| Gastrografin | diatrizoate meglumine and diatrizoate sodium | liquid, oral, rectal | 0270-0445NDA |
| IOMERVU | Iomeprol Injection | injection, solution, intra-arterial, intravenous | 0270-7017NDA |
| IOMERVU | Iomeprol Injection | injection, solution, intra-arterial, intravenous | 0270-7018NDA |
| ISOVUE 200 | IOPAMIDOL | injection, solution, intravascular | 0270-1314NDA |
| ISOVUE 250 | IOPAMIDOL | injection, solution, intravascular | 0270-1317NDA |
| ISOVUE 300 | IOPAMIDOL | injection, solution, intravascular | 0270-1315NDA |
| ISOVUE 370 | IOPAMIDOL | injection, solution, intravascular | 0270-1316NDA |
| ISOVUE-M | IOPAMIDOL | injection, solution, intrathecal | 0270-1411NDA |
| ISOVUE-M | IOPAMIDOL | injection, solution, intrathecal | 0270-1412NDA |
| Iomeron | Iomeprol Injection | injection, solution, intravascular | 0270-7250UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| Iomeron | Iomeprol Injection | injection, solution, intravascular | 0270-7300UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| Iomeron | Iomeprol Injection | injection, solution, intravascular | 0270-7350UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| Iomeron | Iomeprol Injection | injection, solution, intravascular | 0270-7400UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| Iomeron | Iomeprol Injection | injection, solution, intravascular | 0270-9300UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| Iomeron | Iomeprol Injection | injection, solution, intravascular | 0270-9350UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| Iomeron | Iomeprol Injection | injection, solution, intravascular | 0270-9400UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| KINEVAC | sincalide | injection, powder, lyophilized, for solution, intravenous | 0270-0556NDA |
| LumaSon | SULFUR HEXAFLUORIDE | injection, powder, lyophilized, for suspension, intravenous, intravesical | 0270-7097NDA |
| LumaSon | SULFUR HEXAFLUORIDE | kit | 0270-7099NDA |
| MultiHance | gadobenate dimeglumine | injection, solution, intravenous | 0270-5164NDA |
| MultiHance | gadobenate dimeglumine | injection, solution, intravenous | 0270-5264NDA |
| ProHance | gadoteridol | injection, solution, intravenous | 0270-1111NDA |
| Vueway | Gadopiclenol | injection, intravenous | 0270-7015NDA |
| Vueway | Gadopiclenol | injection, intravenous | 0270-7020NDA |
| Vueway | Gadopiclenol | injection, intravenous | 0270-7025NDA |
| Vueway | Gadopiclenol | injection, intravenous | 0270-7030NDA |
| Vueway | Gadopiclenol | injection, intravenous | 0270-7035NDA |
Neighbours
Registered in the same town
7- SGS North America Inc.Plan-les-Ouates, CHE
- EMD Serono, Inc.Colleretto Giacosa, ITA
- Takeda Pharmaceuticals U.S.A., Inc.Singen (Hohentwiel), DEU
- Advanced Accelerator Applications USA, Inc.Colleretto Giacosa, ITA
- KBI Biopharma, Inc.Plan-les-Ouates, CHE
- Primera Analytical Solutions CorporationPrinceton, NJ
- Trifarma S.p.A.CERIANO LAGHETTO, ITA
Compare
Comparable companies in Italy
- Intercos America, Inc.5 sites · 0 NDC
- Dipharma Francis Srl4 sites · 72 NDC
- ACS Dobfar S.p.A.8 sites · 37 NDC
- Flamma USA LLC4 sites · 13 NDC
- Advanced Accelerator Applications USA, Inc.4 sites · 2 NDC
- SICOR Societa' Italiana Corticosteroidi s.r.l. ABBREVIATA IN SICOR S.R.L.4 sites · 0 NDC
- FIS FABBRICA ITALIANA SINTETICI SPA3 sites · 128 NDC
- Curia India Private Limited9 sites · 106 NDC
- Kedrion Biopharma Inc.3 sites · 28 NDC
- Fresenius Kabi iPSUM S.r.l.3 sites · 24 NDC
Enquiry
Common questions
- Is BRACCO DIAGNOSTICS INC FDA approved?
- BRACCO DIAGNOSTICS INC holds 6 FDA-registered establishments across 4 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 BRACCO DIAGNOSTICS INC's drugs manufactured?
- At registered sites in Switzerland, Germany, Italy, the United States. The FDA register lists Plan-les-Ouates; Singen (Hohentwiel); COLLERETTO GIACOSA; Ceriano Laghetto; Torviscosa; Princeton, NJ. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does BRACCO DIAGNOSTICS INC make?
- 31 products are listed under BRACCO DIAGNOSTICS INC in the openFDA NDC Directory, most often as injection, solution; injection; injection, powder, lyophilized, for solution. 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.