Register entry
- Registered sites
- 1
- Active NDC listings
- 3
- Live patents
- 0
- Countries
- 1
- Base
- France
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1sterilize1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| CENEXI HSC | 2 Rue Louis Pasteur, Herouville-Saint-Clair, 14200, France (FRA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3013257850268155718 |
Catalogue
Drug listings by form and route
33 active NDC listings: 3 standardized allergenic. By marketing category: BLA 3.
| Dosage form | NDCs |
|---|---|
| kit | 2 |
| tablet, orally disintegrating | 1 |
| Route | NDCs |
|---|---|
| sublingual | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| cenexi hsc | 3 |
Catalogue
Marketed products
3| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Oralair | ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHELUM PRATENSE POLLEN, and POA PRATENSIS POLLEN | kit | 82454-0020BLA |
| Oralair | ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHELUM PRATENSE POLLEN, and POA PRATENSIS POLLEN | kit | 82454-0025BLA |
| Oralair 300 IR | ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN | tablet, orally disintegrating, sublingual | 82454-0015BLA |
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Enquiry
Common questions
- Is CENEXI HSC FDA approved?
- CENEXI HSC holds 1 FDA-registered establishment in France. 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 CENEXI HSC's drugs manufactured?
- The FDA register lists Herouville-Saint-Clair. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does CENEXI HSC make?
- 3 products are listed under CENEXI HSC in the openFDA NDC Directory, most often as kit; tablet, orally disintegrating. 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.