Unibest

Fondaparinux sodium injection

Formulation (FDF) · injection · 10mg/0.8ml; 7.5mg/0.6ml; 5mg/0.4ml; 2.5mg/0.5ml;

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Formulation (FDF)Confidentiality:Public
INN / Generic Name
Fondaparinux sodium injection
Dosage Form
injection
Strength
10mg/0.8ml; 7.5mg/0.6ml; 5mg/0.4ml; 2.5mg/0.5ml;
Therapy Area
Cardiovascular
Indication
Prevention 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
Current Status
Official FDF licensing catalog (UB835)
GMP Certification
US - FDA
CEP
No
DMF Type
—
Stability Data
—
BE Required
Not required / waivable
Registration Pathway
Registered (market rights transferable / DCP·NP per market)
MOQ
On request
Lead Time
On request
Price Range
On request
HS Code
3004.903 customs bills on file
Registrable Markets
United States

Process / Sequence / Exact Price

Process Summary
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Exact Price