Cadila Pharmaceuticals human insulin
Insulin human biosimilar developed by Cadila Pharmaceuticals. Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Cadila Pharmaceuticals
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCONov 2024permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
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
Cadila Pharmaceuticals Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Nov 2024
Application or permission
MF/BIO/24/000126
Indications as licensed
Diabetes mellitus requiring injectable insulin
Presentations
Biphasic isophane 30/70
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCONov 2024CDSCO permission granted
Sources
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