LG Life Sciences somatropin
Somatropin biosimilar developed by LG Life Sciences. Reference product Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen.
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: LG Life Sciences (import)
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOAug 2002permitted
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 OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
L.G. Chemicals (LG Life Sciences)
Pathway
Import and marketing permission
Approved
Aug 2002
Application or permission
Import permission; sustained-release form 20 December 2013
Indications as licensed
Growth failure in children, including chronic renal insufficiency
Presentations
4 IU vial; sustained-release vial (2013)
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOAug 2002CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
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