Register entry

Unither Manufacturing LLC

Data as of · How to read this entry

Registered sites
3
Active NDC listings
6
Labeller names
2
Live patents
0
Countries
2
Base
France
Authorisation

Registered operations

Analytical testing3Labelling3Finished drug manufacture3Packaging3
Sites

Registered establishments

3
EstablishmentAddressRegistered forFEI / DUNS
Laboratoire UnitherRegistrant: Unither Manufacturing LLC151 rue Andre Durouchez, Amiens, Somme 80080, France (FRA)Analytical testing, Labelling, Finished drug manufacture, Packaging3010162623573215535
Laboratoire UnitherRegistrant: Unither Manufacturing LLC1 Rue De L Arquerie, Coutances, 50200, France (FRA)Analytical testing, Labelling, Finished drug manufacture, Packaging3006974616574139809
Unither Manufacturing LLC755 Jefferson Rd., Rochester, New York (NY) 14623, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging1314625079176615
Catalogue

Drug listings by form and route

6

6 active NDC listings: 4 human otc drug, 2 drug for further processing. By marketing category: UNAPPROVED DRUG OTHER 4, DRUG FOR FURTHER PROCESSING 2.

Dosage formNDCs
liquid4
solution, gel forming / drops1
solution/ drops1
RouteNDCs
nasal4
Labeller name on the listingNDCs
laboratoire unither5
unither manufacturing llc1
Catalogue

Marketed products

6
BrandGeneric nameForm / routeNDC
-BRIMONIDINE TARTRATEsolution/ drops43014-0538DRUG FOR FURTHER PROCESSING
HYDRA NEBSODIUM CHLORIDEliquid, nasal43014-1111UNAPPROVED DRUG OTHER
RESP EASESODIUM CHLORIDEliquid, nasal43014-1112UNAPPROVED DRUG OTHER
RESP EASESODIUM CHLORIDEliquid, nasal43014-1113UNAPPROVED DRUG OTHER
RESP EASESODIUM CHLORIDEliquid, nasal43014-1114UNAPPROVED DRUG OTHER
-carboxymethylcellulose sodium, unspecifiedsolution, gel forming / drops53014-151DRUG FOR FURTHER PROCESSING
Neighbours

Registered in the same town

3
Compare

Comparable companies in France

Enquiry

Common questions

Is Unither Manufacturing LLC FDA approved?
Unither Manufacturing LLC holds 3 FDA-registered establishments across 2 countries. 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 Unither Manufacturing LLC's drugs manufactured?
At registered sites in France, the United States. The FDA register lists Amiens; Coutances; Rochester, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Unither Manufacturing LLC make?
6 products are listed under Unither Manufacturing LLC in the openFDA NDC Directory, most often as liquid; solution, gel forming / drops; solution/ drops. 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.