Register entry
Italfarmaco S.A.
- Registered sites
- 2
- Drug products
- 15
- Live patents
- 6
- Countries
- 2
- Base
- Italy
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackaging
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| Italfarmaco S.A. | AlcobendasSpain | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3007048260 |
| Italfarmaco SPA | MilanItaly | Analytical testing, Labelling, Finished drug manufacture, Packaging | 0001196 |
Exclusivity
Patents
6Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| DUVYZAT | GIVINOSTAT HYDROCHLORIDE | Jan 2027 |
| DUVYZAT | GIVINOSTAT HYDROCHLORIDE | Feb 2032 |
| DUVYZAT | GIVINOSTAT HYDROCHLORIDE | Oct 2036 |
| DUVYZAT | GIVINOSTAT HYDROCHLORIDE | May 2040 |
| TIGLUTIK KIT | RILUZOLE | Mar 2029 |
Catalogue
Marketed products
15Showing 15 of 15.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| DUVYZAT | givinostat | SUSPENSION | NDA |
| Enoxaparin Sodium | Enoxaparin Sodium | INJECTION, SOLUTION | ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | INJECTION, SOLUTION | ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | INJECTION, SOLUTION | ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | INJECTION, SOLUTION | ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | INJECTION, SOLUTION | ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | INJECTION, SOLUTION | ANDA |
| Enoxaparin Sodium | Enoxaparin Sodium | INJECTION, SOLUTION | ANDA |
| GLATIRAMER ACETATE | glatiramer acetate | INJECTION, SOLUTION | ANDA |
| GLATIRAMER ACETATE | glatiramer acetate | INJECTION, SOLUTION | ANDA |
| TIGLUTIK | Riluzole | SUSPENSION | NDA |
| fondaparinux sodium | fondaparinux sodium | INJECTION, SOLUTION | ANDA |
| fondaparinux sodium | fondaparinux sodium | INJECTION, SOLUTION | ANDA |
| fondaparinux sodium | fondaparinux sodium | INJECTION, SOLUTION | ANDA |
| fondaparinux sodium | fondaparinux sodium | INJECTION, SOLUTION | ANDA |
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.