UB835
ProductFondaparinux sodium injection
Strength10mg/0.8ml； 7.5mg/0.6ml； 5mg/0.4ml； 2.5mg/0.5ml；
IndicationsPrevention of VTE in major lower limb orthopedic surgery; Treatment of deep vein thrombosis or pulmonary embolism; Treatment of unstable angina or NSTEMI not undergoing early PCI; Treatment of ST‑elevation MI undergoing thrombolysis or without initial reperfusion; Prophylaxis of VTE in acutely ill medical patients with reduced mobility
TherapeuticsCardiovascular
GMPUS - FDA
RegistrationUnited States
ModalitiesSmall Molecule
Exclusive Summary
- Backed by US-FDA GMP and US market registration, it provides top-tier quality endorsement that facilitates rapid regulatory approvals in emerging markets via reliance pathways.
- As a highly complex synthetic pentasaccharide with extreme technical barriers and scarce global generic competitors, it allows distributors to avoid price wars and secure premium profit margins.
- Offering a complete product line from 2.5mg to 10mg, it guarantees precise, HIT-free first-line prophylaxis and weight-adjusted treatment for diverse indispensable clinical needs.
- Supported by China's highly cost-effective and advanced manufacturing supply chain, it offers significant pricing advantages against originators, ensuring distributors’ absolute competitiveness in local institutional tenders.
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