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Anticoagulant · LMWH

Enoxaparin Sodium API Supplier

CAS 679809-58-6  ·  Anticoagulant · Low Molecular Weight Heparin · Biosimilar-Grade

GMP-certified Enoxaparin Sodium API — the world's leading low molecular weight heparin. USDMF on file. Biosimilar-grade documentation. Complete chain of origin documentation for porcine-sourced material.

Request Complete Source Quote View Specifications
Purity≥99.0%HPLC
MOQ20 kgBiosimilar-grade
RegulatoryUSDMFBiosimilar supply grade
Response24 hrFull dossier
OriginMultiIndia / China
Technical Specifications

Enoxaparin Sodium API — Full Technical Profile

INN / Generic NameEnoxaparin Sodium
CAS Number679809-58-6
Molecular FormulaOligosaccharide mixture (porcine-derived)
Molecular WeightAverage Mn ~3,500–5,500 Da
Mechanism / ClassLow molecular weight heparin — anti-Xa and anti-IIa activity; anticoagulant
Therapeutic UseDVT prevention/treatment, pulmonary embolism, acute coronary syndromes (Lovenox® reference)
Purity (HPLC)≥99.0%
AppearanceWhite to off-white amorphous powder
StorageStore below 25°C
MOQ (commercial)20 kg
MOQ (R&D)1 kg – 5 kg
Lead Time5–9 weeks
Regulatory FilingsUSDMF
Country of OriginIndia / China
Regulatory Documentation

Complete Source Quote — What's Included

Every Enoxaparin Sodium API inquiry returns a complete regulatory package in 24 hours.

📋
Certificate of Analysis
Full CoA — anti-Xa activity, anti-IIa activity, Mw/Mn distribution, pH, sulfur content, residual proteins, endotoxins.
✓ Included
🇺🇸
USDMF on File
US Drug Master File active. Supports FDA biosimilar and generic LMWH submissions.
✓ On File
🐖
Chain of Origin (COO)
Full porcine mucosal source traceability — country of origin, slaughterhouse certification, and TSE/BSE documentation.
✓ Included
🧪
Structural Characterisation
NMR and MS characterisation of oligosaccharide chains per Ph.Eur. and USP monographs.
✓ Included
📊
Stability Data
ICH Q1A stability data at 25°C. Activity assays (anti-Xa/anti-IIa) at all time points.
✓ Included
🏭
GMP Certificate
Current GMP certificate from FDA-inspected manufacturing site with LMWH production capability.
✓ Included
Market Context

Enoxaparin Sodium — Key Figures

$5B+
Global LMWH market
Biosimilar-grade
Documentation level
Anti-Xa/IIa
Activity fully characterised
20 kg
Commercial MOQ
Complete Source Quote

Get Your Enoxaparin Sodium API Quote

Submit your requirements. We'll respond with a complete package within 24 business hours.

  • Certificate of Analysis (CoA)
  • USDMF — reference letter / status
  • Full impurity profile per ICH Q3A
  • Stability data summary
  • GMP certificate + site details
  • Pricing, MOQ, and lead time
  • Country of origin confirmation
Enoxaparin Sodium API Inquiry
Complete Source Quote · 24-hour response
PDF · DOC · XLS · Max 10 MB

✓ 24-hour response  ·  [email protected]

Common Questions

Enoxaparin Sodium API — FAQ

What source material is Enoxaparin derived from?
Our Enoxaparin Sodium API is derived from porcine intestinal mucosa — the industry-standard source. Full chain of origin documentation including country of origin, slaughterhouse certification, and TSE/BSE risk assessment is included with every inquiry per FDA and EMA requirements.
What activity specifications are provided for Enoxaparin?
The CoA includes both anti-Xa activity (100 IU/mg) and anti-IIa activity (approximately 28 IU/mg), with the anti-Xa/anti-IIa ratio specified per Ph.Eur. and USP monographs. Molecular weight distribution (Mw, Mn, Mw/Mn) is also characterised by SEC-MALS.
Is Enoxaparin available for biosimilar development programmes?
Yes — Generic Specialty specifically offers biosimilar-grade Enoxaparin with the enhanced documentation package required for biosimilar development: structural characterisation by NMR and MS, comparative physicochemical data, and full chain of origin traceability.
Does Generic Specialty Group manufacture Enoxaparin Sodium?
No — Generic Specialty Group is an independent API sourcing partner, not a manufacturer. We source from a curated network of GMP-audited manufacturers globally, giving you access to multiple qualified sources and competitive pricing without being tied to a single facility.
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