Dr. Reddy's pegfilgrastim
Pegfilgrastim biosimilar developed by Dr. Reddy's Laboratories. Reference product Neulasta.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Dr. Reddy's Laboratories
FDAnot listed
EMAnot listed
CDSCOJan 2011permitted
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
Dr. Reddy's Laboratories Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2011
Application or permission
MF-05/2011
Indications as licensed
Neutropenia in cytotoxic chemotherapy for non-myeloid malignancy
Presentations
6 mg/0.6 mL PFS
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJan 2011CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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