Home/Biosimilar Atlas/Insulin human/Gland Pharma human insulin

Gland Pharma human insulin

Insulin human biosimilar developed by Gland Pharma. 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: Gland Pharma
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOAug 2011permitted
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 OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Gland Pharma Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2011
Application or permission
MF-334/2011
Indications as licensed
Type 1 and type 2 diabetes
Presentations
Biphasic isophane 30/70
Note
First human insulin permission in the published CDSCO lists.
Source
S014
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All insulin human biosimilars

Planning insulin human biosimilar development?

EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.

Talk to a biosimilar regulatory consultant
Data current to September 2026.