Cipla insulin glargine
Insulin glargine biosimilar developed by Cipla. Reference product Lantus.
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: Cipla (import)
FDAnot listed
EMAnot listed
CDSCOAug 2023permitted
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
Cipla Limited
Pathway
Import and marketing permission
Approved
Aug 2023
Application or permission
IMP/BIO/23/000076 (additional marketing authorisation)
Indications as licensed
Diabetes mellitus in adults, adolescents and children
Presentations
100 U/mL, 3 mL cartridge and pre-filled pen
Source
S012
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOAug 2023CDSCO 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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