Lupin 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) · Commercial partner or holder: Lupin (import)
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOAug 2011permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Lupin epoetin
Lupin has held an Indian import permission for epoetin since 2011, in pre-filled syringes. The manufacturer is not named in the published list.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
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
Lupin Limited
Pathway
Import and marketing permission
Approved
Aug 2011
Application or permission
Import permission
Indications as licensed
Anaemia due to renal insufficiency
Presentations
2,000 to 10,000 IU PFS
Source
S013 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Lupin epoetin holds an approval, these are the other epoetin alfa and zeta biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 4 | Bioviz Technologies (Bioviz epoetin), Not stated in the CDSCO list (Cipla epoetin), Wockhardt (Wockhardt epoetin), Zydus Lifesciences (Zydus epoetin) |
Chronology
- CDSCOAug 2011CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) 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.