Register entry
- Registered sites
- 2
- Active NDC listings
- 15
- Labeller names
- 3
- Live patents
- 6
- Exclusivities
- 1
- Countries
- 2
- Base
- Italy
Authorisation
Registered operations
Analytical testing2Labelling2Finished drug manufacture2Packaging2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Italfarmaco S.A. | CALLE DE SAN RAFAEL (P I ALCOBENDAS) 3, Alcobendas, Madrid 28108, Spain (ESP) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3007048260469466825 |
| Italfarmaco SPA | viale Fulvio Testi 330, Milan, - 20126, Italy (ITA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 0001196428179329 |
Catalogue
Drug listings by form and route
1515 active NDC listings: 15 human prescription drug. By marketing category: ANDA 13, NDA 2.
| Dosage form | NDCs |
|---|---|
| injection, solution | 13 |
| suspension | 2 |
| Route | NDCs |
|---|---|
| subcutaneous | 13 |
| intravenous | 7 |
| oral | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| italfarmaco spa | 9 |
| italfarmaco s.p.a | 4 |
| italfarmaco spa | 2 |
Exclusivity
Patents and exclusivities
6| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7329689 | DUVYZATgivinostat hydrochloride | substance, product | Jan 2027 |
| 8765150 | TIGLUTIK KITriluzole | product | Mar 2029 |
| 9421184 | DUVYZATgivinostat hydrochloride | use | Feb 2032 |
| 9867799 | DUVYZATgivinostat hydrochloride | use | Feb 2032 |
| 10688047 | DUVYZATgivinostat hydrochloride | product | Oct 2036 |
| 12606519 | DUVYZATgivinostat hydrochloride | substance, product | May 2040 |
| Product | Exclusivity | Until |
|---|---|---|
| DUVYZATGIVINOSTAT HYDROCHLORIDE | ODE-473 Orphan drug | Mar 2031 |
Catalogue
Marketed products
15| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| DUVYZAT | givinostat | suspension, oral | 11797-110NDA |
| Enoxaparin Sodium | Enoxaparin Sodium | injection, solution, intravenous, subcutaneous | 11797-757ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | injection, solution, intravenous, subcutaneous | 11797-758ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | injection, solution, intravenous, subcutaneous | 11797-759ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | injection, solution, intravenous, subcutaneous | 11797-760ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | injection, solution, intravenous, subcutaneous | 11797-761ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | injection, solution, intravenous, subcutaneous | 11797-762ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | injection, solution, intravenous, subcutaneous | 11797-763ANDA |
| GLATIRAMER ACETATE | glatiramer acetate | injection, solution, subcutaneous | 11797-764ANDA |
| GLATIRAMER ACETATE | glatiramer acetate | injection, solution, subcutaneous | 11797-765ANDA |
| TIGLUTIK | Riluzole | suspension, oral | 11797-210NDA |
| fondaparinux sodium | fondaparinux sodium | injection, solution, subcutaneous | 11797-154ANDA |
| fondaparinux sodium | fondaparinux sodium | injection, solution, subcutaneous | 11797-155ANDA |
| fondaparinux sodium | fondaparinux sodium | injection, solution, subcutaneous | 11797-156ANDA |
| fondaparinux sodium | fondaparinux sodium | injection, solution, subcutaneous | 11797-157ANDA |
Compare
Comparable companies in Italy
- Erregierre SpA2 sites · 36 NDC
- Novo Nordisk Production Belgium SA2 sites · 24 NDC
- Indena SpA2 sites · 15 NDC
- Lusochimica SPA2 sites · 13 NDC
- Doppel Farmaceutici S.r.l.2 sites · 10 NDC
- Trifarma S.p.A.2 sites · 10 NDC
- CHEMI SpA2 sites · 4 NDC
- OPOCRIN SPA2 sites · 2 NDC
- ALFASIGMA SPA2 sites · 1 NDC
- AMSA Anonima Materie Sintetiche ED Affini Spa2 sites · 0 NDC
Enquiry
Common questions
- Is Italfarmaco S.A. FDA approved?
- Italfarmaco S.A. holds 2 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 Italfarmaco S.A.'s drugs manufactured?
- At registered sites in Spain, Italy. The FDA register lists Alcobendas; Milan. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Italfarmaco S.A. make?
- 15 products are listed under Italfarmaco S.A. in the openFDA NDC Directory, most often as injection, solution; suspension. 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.