Register entry
- Registered sites
- 1
- Active NDC listings
- 0
- Live patents
- 11
- Countries
- 1
- Base
- United Kingdom
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Norgine LimitedRegistrant: Norgine B.V. | 7 Tir-y-berth Industrial Estate New Road, Tir-y-berth, Hengoed, CF82 8SJ, United Kingdom (GBR) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005202761239828197 |
Exclusivity
Patents and exclusivities
11| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10780112 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Mar 2032 |
| 10792306 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Mar 2032 |
| 11529368 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Mar 2032 |
| 10646512 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Mar 2032 |
| 9592252 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Aug 2032 |
| 10016504 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Sept 2033 |
| 10918723 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | use | Sept 2033 |
| 12083179 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Sept 2033 |
| 8999313 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Sept 2033 |
| 9326969 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | use | Sept 2033 |
| 9707297 | PLENVUascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | product | Sept 2033 |
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Enquiry
Common questions
- Is Norgine B.V. FDA approved?
- Norgine B.V. 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 Norgine B.V.'s drugs manufactured?
- The FDA register lists Hengoed. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
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.