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) ยท Commercial partner or holder: Lupin (import)
FDAnot listed
EMAnot listed
CDSCOApr 2024permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
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
EDE
United Arab Emirates
Not listed by EDE.
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)
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