Inhixa
Enoxaparin sodium biosimilar developed by Techdow (Shenzhen Techdow Pharmaceutical). Reference product Clexane (Lovenox in the United States).
Brands by market: Inhixa (EU, UAE) · Commercial partner or holder: Techdow Pharma Netherlands
FDAnot listed
EMASep 2016authorised
PMDAnot listed
HCDec 2020approved
CDSCOnot listed
EDEJun 2019registered
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Inhixa
European Medicines Agency and European CommissionApprovedBrand
Inhixa
Holder or applicant
Techdow Pharma Netherlands B.V.
Pathway
Centralised (Article 10(4))
Approved
Sep 2016
Application or permission
EMEA/H/C/004264
Indications as licensed
VTE prophylaxis and treatment, unstable angina and NSTEMI, STEMI, haemodialysis circuit
Presentations
see SmPC
Note
First EU enoxaparin biosimilar.
Source
S017
PMDA
Japan
Not listed by PMDA.
HC
Canada · Redesca
Health CanadaApprovedBrand
Redesca
Holder or applicant
Shenzhen Techdow Pharmaceutical CO., LTD.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Dec 2020
Application or permission
DIN 02509075, 02509083, 02509091, 02509105, 02509113, 02509121, 02509148, 02509156
Presentations
100, 30, 300, 40, 60, 80 mg; 120, 150 mg
Note
Also Redesca Hp.
Source
S022
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Inhixa
Emirates Drug EstablishmentRegisteredBrand
Inhixa
Holder or applicant
SciencePharma Sp. z o.o., Poland (for Techdow) · UAE supplier Quadri Pharmaceuticals Store
Pathway
Registered medical product
Registered
Jun 2019
Presentations
2,000 IU/0.2 mL to 15,000 IU/mL PFS
Source
S018
Chronology
- EMASep 2016Authorised by the European Commission as Inhixa
- EDEJun 2019Registered in the UAE as Inhixa
- HCDec 2020Notice of Compliance, Health Canada as Redesca
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) 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.