Cadila Pharmaceuticals filgrastim
Filgrastim biosimilar developed by Cadila Pharmaceuticals. Reference product Neupogen.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Cadila Pharmaceuticals
FDAnot listed
EMAnot listed
CDSCOOct 2013permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Cadila Pharmaceuticals Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Oct 2013
Application or permission
MF-135/2013; drug substance BULK-70/2016
Indications as licensed
Neutropenia in cytotoxic chemotherapy
Presentations
300 mcg/mL PFS
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOOct 2013CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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