SciGen somatropin
Somatropin biosimilar developed by SciGen. 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: SciGen Biopharma (import)
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOJun 2010permitted
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
SciGen Biopharma Pvt Ltd
Pathway
Import and marketing permission
Approved
Jun 2010
Application or permission
Import permission
Indications as licensed
Growth failure in children due to growth hormone deficiency
Presentations
Powder and solution for injection
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2010CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
Planning somatropin biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.