Wockhardt epoetin
Epoetin alfa and zeta biosimilar developed by Wockhardt. Reference product Eprex (Epogen and Procrit in the United States).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Wockhardt
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOFeb 2023permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Wockhardt Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Feb 2023
Application or permission
MF/BIO/23/000006
Indications as licensed
Anaemia of chronic renal failure in haemodialysis and peritoneal dialysis
Presentations
Injection
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOFeb 2023CDSCO permission granted
Sources
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