Cipla somatropin
Somatropin biosimilar developed by Not stated in the CDSCO list. Reference product Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen.
Brands by market: Brand not published by CDSCO (India, import) · Commercial partner or holder: Cipla (import)
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOOct 2020permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Cipla somatropin
Cipla received an Indian import permission for somatropin in October 2020, in vials with solvent. The manufacturer is not named in the published list.
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
Cipla Limited
Pathway
Import and marketing permission
Approved
Oct 2020
Application or permission
IMP/BIO/20/000082 (additional marketing authorisation)
Indications as licensed
Growth failure in children due to growth hormone deficiency
Presentations
4 IU vial with solvent
Source
S012 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Cipla 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), Reliance Life Sciences (Reliance Life Sciences somatropin), SciGen (SciGen somatropin), USV (USV somatropin) |
Chronology
- CDSCOOct 2020CDSCO permission granted
Sources
S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)
Planning somatropin biosimilar development?
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