Home/Biosimilar Atlas/Epoetin alfa and zeta/Cipla epoetin

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) · Commercial partner or holder: Cipla (import)
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCONov 2021permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
Epoetin alfa and zetamoleculeNot stated in the CDSCO listdeveloper1 of 7markets0trials behind it0other products, same developer4rival developers in its markets

About Cipla epoetin

Cipla received Indian import permissions for epoetin in late 2021, in vials and 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 OrganisationApproved
Brand
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 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Cipla epoetin holds an approval, these are the other epoetin alfa and zeta biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO4Bioviz Technologies (Bioviz epoetin), Not stated in the CDSCO list (Lupin epoetin), Wockhardt (Wockhardt epoetin), Zydus Lifesciences (Zydus epoetin)

Chronology

Sources

All epoetin alfa and zeta biosimilars

Planning epoetin alfa and zeta biosimilar development?

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Data current to September 2026.