Lupin human insulin
Insulin human biosimilar developed by Not stated in the CDSCO list. Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).
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
CDSCOJan 2024permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Lupin human insulin
Lupin holds Indian import permissions from 2024 for human insulin in intermediate, premixed and fast-acting 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
Jan 2024
Application or permission
IMP/BIO/24/000008 (isophane); IMP/BIO/24/000009 (biphasic 30/70); IMP/BIO/24/000041 (human insulin, April 2024)
Indications as licensed
Diabetes mellitus
Presentations
Isophane, biphasic 30/70 and soluble presentations
Source
S012 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Lupin human insulin holds an approval, these are the other insulin human biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 8 | Biocon Biologics (Biocon human insulin), Cadila Pharmaceuticals (Cadila Pharmaceuticals human insulin), Epygen Biotech (Epygen human insulin), Eris Lifesciences (Eris human insulin), Gland Pharma (Gland Pharma human insulin), M.J. Biopharm (M.J. Biopharm human insulin), Regenix (Regenix human insulin), Sanofi (Shantha human insulin) |
Chronology
- CDSCOJan 2024CDSCO permission granted
Sources
S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)
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