Lupin 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: Lupin (import)
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOApr 2024permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Lupin insulin lispro
Lupin holds Indian import permissions for insulin lispro from April 2024, for the standard product and the two premixed forms. 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
Apr 2024
Application or permission
IMP/BIO/24/000038; IMP/BIO/24/000039 (25/75 premix); IMP/BIO/24/000037 (50/50 premix)
Indications as licensed
Diabetes mellitus
Presentations
3 mL cartridge and pre-filled pen; 25/75 and 50/50 premixes
Source
S012 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Lupin insulin lispro holds an approval, these are the other insulin lispro biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 1 | Not stated in the CDSCO list (Cipla insulin lispro) |
Chronology
- CDSCOApr 2024CDSCO permission granted
Sources
S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)
Planning insulin lispro biosimilar development?
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