USV somatropin
Somatropin biosimilar developed by USV. Reference product Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: USV
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOJun 2013permitted
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
USV Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2013
Application or permission
MF-112/2013
Indications as licensed
Growth hormone deficiency in prepubertal children (4 to 12 years)
Presentations
Injection
Note
First domestic somatropin permitted in India.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2013CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 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.