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) · Commercial partner or holder: SciGen Biopharma (import) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJun 2010permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About SciGen somatropin
SciGen, originally an Australian company, has held an Indian import permission for its somatropin since 2010. It is one of several imported somatropins on the Indian market.
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 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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where SciGen somatropin holds an approval, these are the other somatropin biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 4 | LG Chem (LG Life Sciences somatropin), Not stated in the CDSCO list (Cipla somatropin), Reliance Life Sciences (Reliance Life Sciences somatropin), USV (USV somatropin) |
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.