Shantha human insulin
Insulin human biosimilar developed by Shantha Biotechnics (Sanofi). Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).
About Shantha human insulin
Shantha Biotechnics, a Sanofi subsidiary in Hyderabad, received a permission for fast-acting human insulin in November 2013, made in India for the Indian market.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Shantha human insulin holds an approval, these are the other insulin human biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 8 | Biocon Biologics (Biocon human insulin), Cadila Pharmaceuticals (Cadila Pharmaceuticals human insulin), Epygen Biotech (Epygen human insulin), Eris Lifesciences (Eris human insulin), Gland Pharma (Gland Pharma human insulin), M.J. Biopharm (M.J. Biopharm human insulin), Not stated in the CDSCO list (Lupin human insulin), Regenix (Regenix human insulin) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Sanofi: Insulin lispro Sanofi, Merilog / Insulin aspart Sanofi.
Chronology
- CDSCONov 2013CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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