Register entry
- Registered sites
- 1
- Active NDC listings
- 21
- Labeller names
- 4
- Live patents
- 34
- Exclusivities
- 1
- Countries
- 1
- Base
- France
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Recordati Rare Diseases | Tour Hekla, 52 avenue du G�n�ral de Gaulle, Puteaux, - 92800, France (FRA) | Finished drug manufacture | 3008341412767598352 |
Catalogue
Drug listings by form and route
2121 active NDC listings: 21 human prescription drug. By marketing category: NDA 17, BLA 4.
| Dosage form | NDCs |
|---|---|
| kit | 5 |
| tablet, coated | 4 |
| injection | 3 |
| injection, powder, for solution | 2 |
| powder, for solution | 2 |
| solution | 2 |
| capsule | 1 |
| injection, solution, concentrate | 1 |
| tablet, for suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 7 |
| intravenous | 5 |
| subcutaneous | 3 |
| ophthalmic | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| recordati rare diseases, inc. | 17 |
| recordati rare diseases | 2 |
| recordati rare diseases inc. | 1 |
| recordati rare diseases, inc. | 1 |
Exclusivity
Patents and exclusivities
34| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7759308 | SIGNIFOR LAR KITpasireotide pamoate | product | Oct 2026 |
| 7473761 | SIGNIFOR, SIGNIFOR LAR KITpasireotide diaspartate; pasireotide pamoate | substance, product | Dec 2026 |
| 9351923 | SIGNIFOR LAR KITpasireotide pamoate | product | May 2028 |
| 8314097 | ISTURISAosilodrostat phosphate | substance, product | Mar 2029 |
| 8609862 | ISTURISAosilodrostat phosphate | use | Jan 2031 |
| 9434754 | ISTURISAosilodrostat phosphate | substance | Jan 2031 |
| 8415337 | NEOPROFENibuprofen lysine | substance, product | Mar 2032 |
| 10143680 | ISTURISAosilodrostat phosphate | product | Jul 2035 |
| 10709691 | ISTURISAosilodrostat phosphate | use | Oct 2035 |
| Product | Exclusivity | Until |
|---|---|---|
| ISTURISAOSILODROSTAT PHOSPHATE | ODE-535 Orphan drug | Apr 2032 |
Catalogue
Marketed products
21| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| CYSTADROPS | cysteamine hydrochloride | solution, ophthalmic | 55292-410NDA |
| Carbaglu | Carglumic Acid | tablet, for suspension, oral | 52276-312NDA |
| Chemet | succimer | capsule, oral | 55292-201NDA |
| Cystadane | betaine | powder, for solution, oral | 52276-400NDA |
| Enjaymo | sutimlimab-jome | injection, solution, concentrate, intravenous | 55292-820BLA |
| Isturisa | osilodrostat | tablet, coated, oral | 55292-320NDA |
| Isturisa | OSILODROSTAT | tablet, coated, oral | 55292-321NDA |
| Isturisa | Osilodrostat | tablet, coated, oral | 55292-330NDA |
| Isturisa | Osilodrostat | tablet, coated, oral | 55292-331NDA |
| NEOPROFEN | ibuprofen lysine | solution, intravenous | 55292-122NDA |
| Panhematin | hemin | powder, for solution, intravenous | 55292-702BLA |
| Signifor | pasireotide | injection, subcutaneous | 55292-131NDA |
| Signifor | pasireotide | injection, subcutaneous | 55292-132NDA |
| Signifor | pasireotide | injection, subcutaneous | 55292-133NDA |
| Signifor LAR | pasireotide | kit | 55292-139NDA |
| Signifor LAR | pasireotide | kit | 55292-140NDA |
| Signifor LAR | pasireotide | kit | 55292-141NDA |
| Signifor LAR | pasireotide | kit | 55292-142NDA |
| Signifor LAR | pasireotide | kit | 55292-143NDA |
| Sylvant | Siltuximab | injection, powder, for solution, intravenous | 73090-420BLA |
| Sylvant | Siltuximab | injection, powder, for solution, intravenous | 73090-421BLA |
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Enquiry
Common questions
- Is Recordati Rare Diseases FDA approved?
- Recordati Rare Diseases holds 1 FDA-registered establishment in France. 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 Recordati Rare Diseases's drugs manufactured?
- The FDA register lists Puteaux. Registered operations: finished drug manufacture.
- What drugs does Recordati Rare Diseases make?
- 21 products are listed under Recordati Rare Diseases in the openFDA NDC Directory, most often as kit; tablet, coated; injection. 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.