Cipla insulin glargine
Insulin glargine biosimilar developed by Cipla. Reference product Lantus.
Brands by market: Brand not published by CDSCO (India, import) · Commercial partner or holder: Cipla (import) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOAug 2023permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Cipla insulin glargine
Cipla received an Indian import permission for insulin glargine in 2023, in cartridges and pens, adding to the insulin lispro and human insulin it also imports. Cipla's insulin range for India is built on imported products rather than its own manufacture.
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
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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Cipla insulin glargine holds an approval, these are the other insulin glargine biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 9 | Biocon Biologics (Semglee), Eli Lilly (Rezvoglar / Abasaglar), Eris Lifesciences (Eris insulin glargine), Genesys Biologics (Genesys insulin glargine), LG Chem (LG Life Sciences insulin glargine), Lupin (Lupin insulin glargine), M.J. Biopharm (M.J. Biopharm insulin glargine), Regenix (Regenix insulin glargine), Wockhardt (Wockhardt insulin glargine) |
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)
Planning insulin glargine biosimilar development?
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