Register entryShortage reported
BTG International Inc
- Registered sites
- 1
- Drug products
- 9
- Live patents
- 3
- Countries
- 1
- Base
- United Kingdom
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Protherics UK Limited | LlandysulUnited Kingdom | Analytical testing, Active ingredient (API) manufacture | 3001417487 |
Alert
Products in shortage
1| Drug | Presentation | Availability |
|---|---|---|
| Hydroxocobalamin Injection | Cyanokit, Injection, 5 g/250mL (NDC 50633-310-11) | Limited Availability |
Exclusivity
Patents
3Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| AURLUMYN | ILOPROST | Aug 2041 |
| AURLUMYN | ILOPROST | Jul 2044 |
| VISTOGARD | URIDINE TRIACETATE | Aug 2027 |
Catalogue
Marketed products
9Showing 9 of 9.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| AURLUMYN | ILOPROST | INJECTION, SOLUTION | NDA |
| CroFab | ovine crotalidae venoms immune fab | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Cyanokit | Hydroxocobalamin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| DigiFab | ovine digoxin immune fab | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| ThyroSafe | Potassium Iodide | TABLET | ANDA |
| Thyrosafe | Potassium iodide | TABLET | ANDA |
| VISTOGARD | uridine triacetate | GRANULE | NDA |
| Voraxaze | glucarpidase | INJECTION, POWDER, FOR SOLUTION | BLA |
| XURIDEN | uridine triacetate | GRANULE | NDA |
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.