Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 10
- Labeller names
- 3
- Live patents
- 3
- Exclusivities
- 1
- Shortage listings
- 1
- Countries
- 1
- Base
- United Kingdom
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Protherics UK LimitedRegistrant: BTG International Inc | Blaenwaun Ffostrasol, Llandysul, Ceredigion SA44 5JT, United Kingdom (GBR) | Analytical testing, Active ingredient (API) manufacture | 3001417487536591589 |
Alert
Drug shortage listings
1| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Hydroxocobalamin InjectionOther | Cyanokit, Injection, 5 g/250mL (NDC 50633-310-11) | Current | Limited Availability | 4 Nov 20241 Oct 2026 |
Catalogue
Drug listings by form and route
1010 active NDC listings: 6 human prescription drug, 2 human otc drug, 2 plasma derivative. By marketing category: BLA 4, NDA 4, ANDA 2.
| Dosage form | NDCs |
|---|---|
| injection, powder, lyophilized, for solution | 3 |
| granule | 2 |
| tablet | 2 |
| injection | 1 |
| injection, powder, for solution | 1 |
| injection, solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 6 |
| oral | 4 |
| Labeller name on the listing | NDCs |
|---|---|
| btg international inc. | 5 |
| btg international inc | 4 |
| btg international inc. | 1 |
Exclusivity
Patents and exclusivities
3| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7776838 | VISTOGARDuridine triacetate | use | Aug 2027 |
| 12409184 | AURLUMYNiloprost | product | Aug 2041 |
| 12409183 | AURLUMYNiloprost | use | Jul 2044 |
| Product | Exclusivity | Until |
|---|---|---|
| AURLUMYNILOPROST | ODE-465 Orphan drug | Feb 2031 |
Catalogue
Marketed products
10| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AURLUMYN | ILOPROST | injection, solution, intravenous | 50633-340NDA |
| CroFab | ovine crotalidae venoms immune fab | injection, powder, lyophilized, for solution, intravenous | 50633-110BLA |
| Cyanokit | Hydroxocobalamin | injection, powder, lyophilized, for solution, intravenous | 50633-310NDA |
| DANYELZA | Naxitamab | injection, intravenous | 50633-230BLA |
| DigiFab | ovine digoxin immune fab | injection, powder, lyophilized, for solution, intravenous | 50633-120BLA |
| ThyroSafe | Potassium Iodide | tablet, oral | 50633-910ANDA |
| Thyrosafe | Potassium iodide | tablet, oral | 50633-920ANDA |
| VISTOGARD | uridine triacetate | granule, oral | 50633-220NDA |
| Voraxaze | glucarpidase | injection, powder, for solution, intravenous | 50633-210BLA |
| XURIDEN | uridine triacetate | granule, oral | 50633-330NDA |
Compare
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- Basildon Chemical Co., Ltd.1 site · 3 NDC
- Autolus Inc.1 site · 1 NDC
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Enquiry
Common questions
- Is BTG International Inc FDA approved?
- BTG International Inc holds 1 FDA-registered establishment in the United Kingdom. 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 BTG International Inc's drugs manufactured?
- The FDA register lists Llandysul. Registered operations: analytical testing, active ingredient (API) manufacture.
- What drugs does BTG International Inc make?
- 10 products are listed under BTG International Inc in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; granule; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any BTG International Inc products in shortage?
- 1 presentation is currently listed in the FDA drug shortage database under BTG International Inc, covering Hydroxocobalamin Injection.
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.