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M.J. Biopharm human insulin

Insulin human biosimilar developed by M.J. Biopharm. 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: M.J. Biopharm · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJun 2018permitted
EDENot listed
Approved or registered in 1 of 7 markets

About M.J. Biopharm human insulin

M.J. Biopharm received its human insulin permission in India in June 2018, for the premixed form, adding to its insulin glargine. It is a specialist Indian insulin maker.

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
MJ Biopharm Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2018
Application or permission
MF/BIO/18/000001
Indications as licensed
Diabetes mellitus
Presentations
Biphasic 30/70
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where M.J. Biopharm 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), Gland Pharma (Gland Pharma human insulin), Not stated in the CDSCO list (Lupin human insulin), Regenix (Regenix human insulin), Sanofi (Shantha human insulin)

Same developer, other molecules

Other biosimilars in the Atlas developed by M.J. Biopharm: M.J. Biopharm insulin glargine.

Chronology

Sources

All insulin human biosimilars

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Data current to September 2026.