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Cipla insulin lispro

Insulin lispro biosimilar developed by Not stated in the CDSCO list. Reference product Humalog.

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
CDSCOSep 2021permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Cipla insulin lispro

Cipla holds Indian import permissions for insulin lispro from 2021, for the standard product and the two premixed forms, and from 2023 for an ultra-rapid version. The published Indian list does not name the manufacturer. Cipla's insulin range for India is built on imported products.

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
Sep 2021
Application or permission
IMP/BIO/21/000084 (25/75 premix, September 2021); IMP/BIO/21/000085 (October 2021); IMP/BIO/21/000100 (50/50 premix, December 2021); IMP/BIO/23/000049 (ultra-rapid, April 2023)
Indications as licensed
Diabetes mellitus
Presentations
100 IU/mL cartridge and pen; 200 U/mL pen; 25/75 and 50/50 premixes; ultra-rapid 100 U/mL (2023)
Source
S012 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Cipla insulin lispro holds an approval, these are the other insulin lispro biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO1Not stated in the CDSCO list (Lupin insulin lispro)

Chronology

Sources

All insulin lispro biosimilars

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Data current to September 2026.