Cipla epoetin
Epoetin alfa and zeta biosimilar developed by Not stated in the CDSCO list. Reference product Eprex (Epogen and Procrit in the United States).
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: Cipla (import)
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCONov 2021permitted
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
Cipla Limited
Pathway
Import and marketing permission
Approved
Nov 2021
Application or permission
IMP/BIO/21/000096; IMP/BIO/21/000106 (December 2021)
Indications as licensed
Anaemia in chronic renal failure
Presentations
Vials and PFS
Source
S012
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCONov 2021CDSCO permission granted
Sources
S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)
Planning epoetin alfa and zeta biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.