Zydus epoetin
Epoetin alfa and zeta biosimilar developed by Cadila Healthcare (Zydus Lifesciences). Reference product Eprex (Epogen and Procrit in the United States).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Zydus Lifesciences
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOApr 2010permitted
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
Cadila Healthcare Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Apr 2010
Application or permission
MF-406/10; drug substance BULK-224/2014
Indications as licensed
Maintaining haemoglobin in chronic renal failure
Presentations
Lyophilised injection
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOApr 2010CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning epoetin alfa and zeta biosimilar development?
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