Wockhardt insulin glargine
Insulin glargine biosimilar developed by Wockhardt. Reference product Lantus.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Wockhardt
FDAnot listed
EMAnot listed
CDSCOFeb 2007permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
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
Note
First insulin glargine biosimilar permitted in India.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOFeb 2007CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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