Register entry

Vifor (International) AG

Data as of · How to read this entry

Registered sites
1
Active NDC listings
22
Labeller names
3
Live patents
40
Countries
1
Base
Switzerland
Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1
Sites

Registered establishments

1
EstablishmentAddressRegistered forFEI / DUNS
Vifor (International) Inc.Registrant: Vifor (International) AGRechenstrasse 37, St. Gallen, 9014, Switzerland (CHE)Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture3002808450482603065
Catalogue

Drug listings by form and route

22

22 active NDC listings: 20 human prescription drug, 1 bulk ingredient, 1 drug for further processing. By marketing category: BLA 15, NDA 5, BULK INGREDIENT 1, DRUG FOR FURTHER PROCESSING 1.

Dosage formNDCs
injection, solution16
powder, for suspension4
liquid1
powder1
RouteNDCs
intravenous16
subcutaneous6
oral4
Labeller name on the listingNDCs
vifor (international) inc.17
vifor pharma, inc.4
vifor (international), inc.1
Exclusivity

Patents and exclusivities

40
PatentProductCoversExpiry
8216560VELTASSApatiromer sorbitex calciumuseMar 2027
8282913VELTASSApatiromer sorbitex calciumproductMay 2027
10017536KORSUVAdifelikefalin acetatesubstanceNov 2027
10138270KORSUVAdifelikefalin acetateuseNov 2027
10793596KORSUVAdifelikefalin acetatesubstance, productNov 2027
7713937KORSUVAdifelikefalin acetatesubstance, productNov 2027
7727963KORSUVAdifelikefalin acetatesubstance, productNov 2027
8217007KORSUVAdifelikefalin acetateuseNov 2027
8236766KORSUVAdifelikefalin acetateuseNov 2027
8486894KORSUVAdifelikefalin acetateuseNov 2027
8536131KORSUVAdifelikefalin acetatesubstance, productNov 2027
9334305KORSUVAdifelikefalin acetateuseNov 2027
9359399KORSUVAdifelikefalin acetateuseNov 2027
8147873VELTASSApatiromer sorbitex calciumproductJun 2028
8337824VELTASSApatiromer sorbitex calciumsubstanceMay 2030
7402564KORSUVAdifelikefalin acetatesubstance, productNov 2032
11123363VELTASSApatiromer sorbitex calciumuseOct 2033
9492476VELTASSApatiromer sorbitex calciumuseOct 2033
9925212VELTASSApatiromer sorbitex calciumuseOct 2033
Catalogue

Marketed products

22
BrandGeneric nameForm / routeNDC
-Ferric Carboxymaltosepowder59353-363BULK INGREDIENT
-Iron Sucroseliquid59353-652DRUG FOR FURTHER PROCESSING
Korsuvadifelikefalininjection, solution, intravenous59353-065NDA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-400BLA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-401BLA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-402BLA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-403BLA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-404BLA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-405BLA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-406BLA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-407BLA
MirceraMethoxy polyethylene glycol-epoetin betainjection, solution, intravenous59353-408BLA
RETACRITepoetin alfa-epbxinjection, solution, intravenous, subcutaneous59353-002BLA
RETACRITepoetin alfa-epbxinjection, solution, intravenous, subcutaneous59353-003BLA
RETACRITepoetin alfa-epbxinjection, solution, intravenous, subcutaneous59353-004BLA
RETACRITepoetin alfa-epbxinjection, solution, intravenous, subcutaneous59353-010BLA
RETACRITepoetin alfa-epbxinjection, solution, intravenous, subcutaneous59353-120BLA
RETACRITepoetin alfa-epbxinjection, solution, intravenous, subcutaneous59353-220BLA
VELTASSApatiromerpowder, for suspension, oral53436-010NDA
VELTASSApatiromerpowder, for suspension, oral53436-084NDA
VELTASSApatiromerpowder, for suspension, oral53436-168NDA
VELTASSApatiromerpowder, for suspension, oral53436-252NDA
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Enquiry

Common questions

Is Vifor (International) AG FDA approved?
Vifor (International) AG holds 1 FDA-registered establishment in Switzerland. 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 Vifor (International) AG's drugs manufactured?
The FDA register lists St. Gallen. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does Vifor (International) AG make?
22 products are listed under Vifor (International) AG in the openFDA NDC Directory, most often as injection, solution; powder, for suspension; liquid. 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.