Register entry

OPELLA HEALTHCARE INTERNATIONAL SAS

Data as of · How to read this entry

Registered sites
1
Active NDC listings
17
Live patents
0
Countries
1
Base
France
Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1
Sites

Registered establishments

1
EstablishmentAddressRegistered forFEI / DUNS
OPELLA HEALTHCARE INTERNATIONAL SAS56 Route de Choisy, Compiegne, 60200, France (FRA)Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging3003492806275857012
Catalogue

Drug listings by form and route

17

17 active NDC listings: 15 drug for further processing, 2 bulk ingredient. By marketing category: DRUG FOR FURTHER PROCESSING 15, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 2.

Dosage formNDCs
tablet, film coated6
tablet4
tablet, coated3
tablet, film coated, extended release3
tablet, orally disintegrating1
RouteNDCs
Labeller name on the listingNDCs
opella healthcare international sas17
Catalogue

Marketed products

17
BrandGeneric nameForm / routeNDC
-FEXOFENADINE HYDROCHLORIDEtablet, film coated, extended release12579-182DRUG FOR FURTHER PROCESSING
-FEXOFENADINE HYDROCHLORIDEtablet, film coated, extended release12579-189DRUG FOR FURTHER PROCESSING
-Fexofenadine Hydrochloridetablet, orally disintegrating12579-188DRUG FOR FURTHER PROCESSING
-LEVOCETIRIZINE DIHYDROCHLORIDEtablet12579-180DRUG FOR FURTHER PROCESSING
-Tadalafiltablet, coated12579-200DRUG FOR FURTHER PROCESSING
-bisacodyltablet, coated12579-228DRUG FOR FURTHER PROCESSING
-bisacodyltablet, coated12579-230DRUG FOR FURTHER PROCESSING
-fexofenadine hydrochloridetablet, film coated, extended release12579-181DRUG FOR FURTHER PROCESSING
-glyburidetablet12579-054DRUG FOR FURTHER PROCESSING
-glyburidetablet12579-055DRUG FOR FURTHER PROCESSING
-glyburidetablet12579-056DRUG FOR FURTHER PROCESSING
-leflunomidetablet, film coated12579-509BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-leflunomidetablet, film coated12579-510BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-teriflunomidetablet, film coated12579-185DRUG FOR FURTHER PROCESSING
-teriflunomidetablet, film coated12579-186DRUG FOR FURTHER PROCESSING
-teriflunomidetablet, film coated12579-190DRUG FOR FURTHER PROCESSING
-teriflunomidetablet, film coated12579-191DRUG FOR FURTHER PROCESSING
Neighbours

Registered in the same town

1
Compare

Comparable companies in France

Enquiry

Common questions

Is OPELLA HEALTHCARE INTERNATIONAL SAS FDA approved?
OPELLA HEALTHCARE INTERNATIONAL SAS 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 OPELLA HEALTHCARE INTERNATIONAL SAS's drugs manufactured?
The FDA register lists Compiegne. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does OPELLA HEALTHCARE INTERNATIONAL SAS make?
17 products are listed under OPELLA HEALTHCARE INTERNATIONAL SAS in the openFDA NDC Directory, most often as tablet, film coated; tablet; tablet, coated. 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.