Register entry
- Registered sites
- 1
- Active NDC listings
- 40
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- Italy
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| BSP Pharmaceuticals SpA | Via Appia Km 65,561, Latina Scalo (LT), 04013, Italy (ITA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3007255826857007830 |
Catalogue
Drug listings by form and route
4040 active NDC listings: 39 drug for further processing, 1 human prescription drug. By marketing category: DRUG FOR FURTHER PROCESSING 39, NDA 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 17 |
| injection | 10 |
| injection, powder, lyophilized, for solution | 9 |
| powder, for solution | 2 |
| tablet | 1 |
| tablet, film coated | 1 |
| Route | NDCs |
|---|---|
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| bsp pharmaceuticals s.p.a. | 27 |
| bsp pharmaceuticals spa | 13 |
Catalogue
Marketed products
40| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Bendamustine HCI Injection | injection, solution | 43624-009DRUG FOR FURTHER PROCESSING |
| - | Bendamustine HCI Injection | injection, solution | 43624-010DRUG FOR FURTHER PROCESSING |
| - | Bortezomib 3.5mg/vial | injection, powder, lyophilized, for solution | 43624-024DRUG FOR FURTHER PROCESSING |
| - | Denileukin diftitox lyo 300 mcg/vial CIT | injection | 43624-027DRUG FOR FURTHER PROCESSING |
| - | Donanemab | injection, solution | 43624-044DRUG FOR FURTHER PROCESSING |
| Halaven | eribulin mesylate | injection, intravenous | 43624-002NDA |
| - | Loncastuximab tesirine | injection, powder, lyophilized, for solution | 43624-004DRUG FOR FURTHER PROCESSING |
| - | Mirikizumab Inj 300 mg/15 mL Vial Reform | injection | 43624-026DRUG FOR FURTHER PROCESSING |
| - | Mirikizumab Inj 300 mg/15mL Vial | injection | 43624-025DRUG FOR FURTHER PROCESSING |
| - | Multiple-Dose Tirzepatide Injection | injection, solution | 43624-033DRUG FOR FURTHER PROCESSING |
| - | Multiple-Dose Tirzepatide Injection | injection, solution | 43624-034DRUG FOR FURTHER PROCESSING |
| - | Multiple-Dose Tirzepatide Injection | injection, solution | 43624-035DRUG FOR FURTHER PROCESSING |
| - | Multiple-Dose Tirzepatide Injection | injection, solution | 43624-036DRUG FOR FURTHER PROCESSING |
| - | Multiple-Dose Tirzepatide Injection | injection, solution | 43624-037DRUG FOR FURTHER PROCESSING |
| - | Multiple-Dose Tirzepatide Injection | injection, solution | 43624-038DRUG FOR FURTHER PROCESSING |
| - | Patritumab deruxtecan | injection, powder, lyophilized, for solution | 43624-021DRUG FOR FURTHER PROCESSING |
| - | Pemetrexed disodium heptahydrate | powder, for solution | 43624-005DRUG FOR FURTHER PROCESSING |
| - | Pemetrexed disodium heptahydrate | powder, for solution | 43624-006DRUG FOR FURTHER PROCESSING |
| - | Pivekimab sunirine drug product (DP) | injection, powder, lyophilized, for solution | 43624-039DRUG FOR FURTHER PROCESSING |
| - | Polatuzumab Vedotin lyophilized vials 140 mg | injection, powder, lyophilized, for solution | 43624-043DRUG FOR FURTHER PROCESSING |
| - | Polatuzumab Vedotin lyophilized vials 30 mg | injection, powder, lyophilized, for solution | 43624-042DRUG FOR FURTHER PROCESSING |
| - | TAR-200 | tablet | 43624-032DRUG FOR FURTHER PROCESSING |
| - | Telisotuzumab vedotin | injection | 43624-029DRUG FOR FURTHER PROCESSING |
| - | Trastuzumab Emtansine drug product 100 mg | injection, powder, lyophilized, for solution | 43624-040DRUG FOR FURTHER PROCESSING |
| - | Trastuzumab Emtansine drug product 160 mg | injection, powder, lyophilized, for solution | 43624-041DRUG FOR FURTHER PROCESSING |
| - | cedazuridine and decitabine | tablet, film coated | 43624-022DRUG FOR FURTHER PROCESSING |
| - | enfortumab vedotin-ejfv for injection | injection | 43624-014DRUG FOR FURTHER PROCESSING |
| - | enfortumab vedotin-ejfv for injection | injection | 43624-023DRUG FOR FURTHER PROCESSING |
| - | mirvetuximab soravtansine gynx | injection | 43624-012DRUG FOR FURTHER PROCESSING |
| - | pembrolizumab and berahyaluronidase alfa | injection, solution | 43624-030DRUG FOR FURTHER PROCESSING |
| - | pembrolizumab and berahyaluronidase alfa | injection, solution | 43624-031DRUG FOR FURTHER PROCESSING |
| - | sacituzumab govitecan | injection, powder, lyophilized, for solution | 43624-008DRUG FOR FURTHER PROCESSING |
| - | telisotuzumab vedotin | injection | 43624-028DRUG FOR FURTHER PROCESSING |
| - | tirzepatide | injection, solution | 43624-015DRUG FOR FURTHER PROCESSING |
| - | tirzepatide | injection, solution | 43624-016DRUG FOR FURTHER PROCESSING |
| - | tirzepatide | injection, solution | 43624-017DRUG FOR FURTHER PROCESSING |
| - | tirzepatide | injection, solution | 43624-018DRUG FOR FURTHER PROCESSING |
| - | tirzepatide | injection, solution | 43624-019DRUG FOR FURTHER PROCESSING |
| - | tirzepatide | injection, solution | 43624-020DRUG FOR FURTHER PROCESSING |
| - | vestronidase alfa-vjbk | injection | 43624-013DRUG FOR FURTHER PROCESSING |
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Enquiry
Common questions
- Is BSP Pharmaceuticals SpA FDA approved?
- BSP Pharmaceuticals SpA holds 1 FDA-registered establishment in Italy. 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 BSP Pharmaceuticals SpA's drugs manufactured?
- The FDA register lists Latina Scalo (LT). Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does BSP Pharmaceuticals SpA make?
- 40 products are listed under BSP Pharmaceuticals SpA 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.