Dr. Reddy's darbepoetin alfa
Darbepoetin alfa biosimilar developed by Dr. Reddy's Laboratories. Reference product Aranesp (Nesp in Japan).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Dr. Reddy's Laboratories
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOMar 2010permitted
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
Dr. Reddy's Laboratories Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2010
Application or permission
MF-246/10; BULK-668/10 (July 2010)
Indications as licensed
Anaemia of chronic renal failure
Presentations
Injection
Note
First darbepoetin alfa biosimilar permitted anywhere.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMar 2010CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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