Ledraxen
Enoxaparin sodium biosimilar developed by Not stated in the EDE directory. Reference product Clexane (Lovenox in the United States).
Brands by market: Ledraxen (UAE) · Commercial partner or holder: Pharmalink Store (UAE supplier)
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOnot listed
EDEOct 2021registered
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
Not listed by CDSCO.
EDE
United Arab Emirates · Ledraxen
Emirates Drug EstablishmentRegisteredBrand
Ledraxen
Holder or applicant
Centre Specialites Pharmaceutiques, France · UAE supplier Pharmalink Store
Pathway
Registered medical product
Registered
Oct 2021
Presentations
2,000 IU/0.2 mL to 8,000 IU/0.8 mL PFS
Source
S018
Chronology
- EDEOct 2021Registered in the UAE
Sources
S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
Planning enoxaparin sodium biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.