Unibest

Pipeline Database

UB004

Nadroparin Calcium Injection

UB004

ProductNadroparin Calcium Injection
Strength0.4ml:4100AXaIU; 0.6ml:6150AXaIU
IndicationsVenous thromboembolism prophylaxis; Deep vein thrombosis; Unstable angina; Non-Q-wave myocardial infarction; Hemodialysis
TherapeuticsCardiovascular
GMPCN - NMPA; EU - EMA
RegistrationChina
ModalitiesPolysaccharide

Exclusive Summary

  • Possesses EU-EMA GMP certification and BP/EP compliant API, overcoming the high regulatory barriers of low molecular weight heparins to enable rapid entry into European and PIC/S markets.
  • Covers massive therapeutic demands, including over 10 million annual VTE cases and 3.4 million hemodialysis patients globally, serving as a first-line anticoagulant explicitly recommended by major guidelines.
  • The originator patent has expired, but the complex drug nature results in fewer high-quality global generic competitors, avoiding severe homogeneous price wars.
  • Available in mainstream pre-filled syringe dosages (0.4ml/0.6ml), highly ready for use and perfectly suited for immediate global Distribution partnerships.
  • Leverages China's vertically integrated heparin supply chain to ensure stable supply and significantly lower costs compared to the originator (Fraxiparine), securing high margins for distributors.

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