Zydus follitropin alfa
Follitropin alfa biosimilar developed by Cadila Healthcare (Zydus Lifesciences). Reference product Gonal-f.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Zydus Lifesciences
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOJan 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
Cadila Healthcare Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2018
Application or permission
MF-208/2017; Bulk-209/2017
Indications as licensed
Anovulation including polycystic ovarian syndrome; assisted reproduction
Presentations
Injection
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJan 2018CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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