Reliance Life Sciences somatropin
Somatropin biosimilar developed by Reliance Life Sciences. Reference product Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Reliance Life Sciences
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOMay 2018permitted
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
Reliance Life Sciences Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
May 2018
Application or permission
MF-145/2018; BULK-146/2018
Indications as licensed
Growth failure in children including small for gestational age; growth hormone deficiency
Presentations
Injection
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMay 2018CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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