Epygen human insulin
Insulin human biosimilar developed by Epygen Biotech. 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: Epygen Biotech
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOMay 2021permitted
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
Epygen Biotech Private Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
May 2021
Application or permission
MF/BIO/21/000046
Indications as licensed
Diabetes mellitus
Presentations
Biphasic isophane 30/70
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMay 2021CDSCO permission granted
Sources
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