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Wockhardt insulin glargine

Insulin glargine biosimilar developed by Wockhardt. Reference product Lantus.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Wockhardt · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOFeb 2007permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Wockhardt insulin glargine

Wockhardt received the first insulin glargine permission in India, in February 2007, and one of the first anywhere in the world. The product was permitted in vials, cartridges and a pen, in both the international strength and the 40 units per mL strength still used in India.

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
Wockhardt Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Feb 2007
Application or permission
MF-7206/07
Indications as licensed
Type 1 and type 2 diabetes requiring basal insulin
Presentations
40 IU/mL and 100 IU/mL vials, 100 IU/mL cartridge and disposable pen
Remarks
First insulin glargine biosimilar permitted in India.
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Wockhardt insulin glargine holds an approval, these are the other insulin glargine biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO9Biocon Biologics (Semglee), Cipla (Cipla insulin glargine), Eli Lilly (Rezvoglar / Abasaglar), Eris Lifesciences (Eris insulin glargine), Genesys Biologics (Genesys insulin glargine), LG Chem (LG Life Sciences insulin glargine), Lupin (Lupin insulin glargine), M.J. Biopharm (M.J. Biopharm insulin glargine), Regenix (Regenix insulin glargine)

Same developer, other molecules

Other biosimilars in the Atlas developed by Wockhardt: Wockhardt epoetin, Wockhardt pegfilgrastim.

Chronology

Sources

All insulin glargine biosimilars

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Data current to September 2026.