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
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDEOct 2021registered
Approved or registered in 2 of 7 markets
Connections
About Ledraxen
Ledraxen is an enoxaparin registered in the UAE in October 2021 in four strengths, manufactured in France. The directory does not name the developer, and it has no entry in the other markets covered here.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom · Ledraxen
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Ledraxen
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
2,000 to 10,000 IU syringes
Source
S023 (MHRA Products) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Ledraxen holds an approval, these are the other enoxaparin sodium biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| MHRA | 2 | Not stated in the MHRA list (Ghemaxan), Techdow (Inhixa) |
| EDE | 1 | Techdow (Inhixa) |
Chronology
- EDEOct 2021Registered in the UAE as Ledraxen
Sources
S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) 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.