Shantha human insulin
Insulin human biosimilar developed by Shantha Biotechnics (Sanofi). 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: Shantha Biotechnics
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCONov 2013permitted
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
Shantha Biotechnics Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Nov 2013
Application or permission
MF-243/2013
Indications as licensed
Type 1 and type 2 diabetes
Presentations
Soluble (rapid) insulin
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCONov 2013CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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