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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) · Commercial partner or holder: Gland Pharma · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOAug 2011permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
Insulin humanmoleculeGland Pharmadeveloper1 of 7markets0trials behind it0other products, same developer8rival developers in its markets

About Gland Pharma human insulin

Gland Pharma holds the first human insulin permission in the published Indian lists, from August 2011, for the premixed 30/70 form. Gland is better known as an injectables manufacturer for other companies.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

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
Remarks
First human insulin permission in the published CDSCO lists.
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Gland Pharma human insulin holds an approval, these are the other insulin human biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO8Biocon Biologics (Biocon human insulin), Cadila Pharmaceuticals (Cadila Pharmaceuticals human insulin), Epygen Biotech (Epygen human insulin), Eris Lifesciences (Eris human insulin), M.J. Biopharm (M.J. Biopharm human insulin), Not stated in the CDSCO list (Lupin human insulin), Regenix (Regenix human insulin), Sanofi (Shantha human insulin)

Chronology

Sources

All insulin human biosimilars

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Data current to September 2026.