Register entry
- Registered sites
- 1
- Active NDC listings
- 1
- Live patents
- 16
- Exclusivities
- 1
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Active ingredient (API) manufacture1Labelling1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| LNHC Inc. | 4020 Stirrup Creek Drive Suite 110, Durham, North Carolina (NC) 27703, United States (USA) | Active ingredient (API) manufacture, Labelling | 3035364814119245695 |
Exclusivity
Patents and exclusivities
16| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7812163 | XEGLYZEabametapir | product | Oct 2026 |
| 9399014 | XEPIozenoxacin | use | Dec 2029 |
| 10376538 | ZELSUVMIberdazimer sodium | product | Aug 2030 |
| 9737561 | ZELSUVMIberdazimer sodium | use | Aug 2030 |
| 9526738 | ZELSUVMIberdazimer sodium | product | Sept 2031 |
| 9180200 | XEPIozenoxacin | product | Jan 2032 |
| 10265334 | ZELSUVMIberdazimer sodium | product | Jul 2032 |
| 9289442 | ZELSUVMIberdazimer sodium | product | Jul 2032 |
| 9855211 | ZELSUVMIberdazimer sodium | product | Feb 2034 |
| 11285098 | ZELSUVMIberdazimer sodium | product | Feb 2034 |
| 10258564 | ZELSUVMIberdazimer sodium | use | Nov 2034 |
| 10292389 | XEGLYZEabametapir | product | Dec 2034 |
| 10322081 | ZELSUVMIberdazimer sodium | use | Jul 2035 |
| 10736839 | ZELSUVMIberdazimer sodium | use | Jul 2035 |
| 11040006 | ZELSUVMIberdazimer sodium | product | Jul 2035 |
| 11723858 | ZELSUVMIberdazimer sodium | product | Jul 2035 |
| Product | Exclusivity | Until |
|---|---|---|
| ZELSUVMIBERDAZIMER SODIUM | NCE New chemical entity | Jan 2029 |
Catalogue
Marketed products
1| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ZELSUVMI | berdazimer | kit | 83787-103NDA |
Neighbours
Registered in the same town
12- Almac Clinical Services, LLCDurham, NC · 3 sites
- Merck & Co., Inc.Durham, NC · 2 sites
- KBI Biopharma, Inc.Durham, NC · 2 sites
- PETNET Solutions, Inc.DURHAM, NC
- Novo Nordisk Inc.Durham, NC
- Eli Lilly and CompanyDurham, NC
- Encube Ethicals LimitedDurham, NC
- Oxford Biomedica (UK) LimitedDurham, NC
- United Therapeutics CorporationDurham, NC
- Aurolife Pharma LLCDurham, NC
- Avista Pharma Solutions, Inc. dba CambrexDurham, NC
- BioAgilytix Labs, LLCDurham, NC
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Enquiry
Common questions
- Is LNHC Inc. FDA approved?
- LNHC Inc. holds 1 FDA-registered establishment in the United States. 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 LNHC Inc.'s drugs manufactured?
- The FDA register lists Durham, NC. Registered operations: active ingredient (API) manufacture, labelling.
- What drugs does LNHC Inc. make?
- 1 product is listed under LNHC Inc. in the openFDA NDC Directory, most often as kit. 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.