Enoxaparin Sodium Injection (Low Molecular Weight Heparin)

Enoxaparin Sodium Injection (Low Molecular Weight Heparin)
Product Description

Low molecular weight heparin (LMWH) indicated for the prophylaxis and treatment of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, and for the management of acute coronary syndromes. Enoxaparin offers a predictable anticoagulant response, once or twice daily subcutaneous dosing and no requirement for routine coagulation monitoring in most patients. Manufactured by Regenix in India under WHO-GMP and Schedule M, and offered in pre-filled syringe, cartridge and disposable pen presentations. Each batch is released against identity, purity by RP-HPLC, anti-Xa and anti-IIa potency, sterility (USP <71>) and bacterial endotoxin (USP <85>). Supplied to licensing and distribution partners with a complete CTD/eCTD dossier (Modules 1-5, ICH M4) including ICH Q1A stability data and country-specific Module 1 adaptation.

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Regenix drugs Ltd

  • Country/Region:
    India
  • Founded:
    2006
  • On CPHI since:
    2024
  • Certificates:
    2
  • Employees:
    50 - 99
Company types
Biopharmaceutical company
Generics/Biosimilars Manufacturer
Primary activities
Biopharmaceutical
Pharmaceutical Company (generic finished products)
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Categories
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Specifications
  • Details
    Enoxaparin Sodium, a low molecular weight heparin obtained by depolymerisation of unfractionated heparin.
    • Form: sterile clear solution for injection, administered subcutaneously; intravenous use in specific indications in accordance with approved labelling
    • Presentations: 20 mg, 40 mg, 60 mg and 80 mg pre-filled syringes; also offered as a 3 mL cartridge and a 3 mL disposable pen
    • Indications: prophylaxis and treatment of deep vein thrombosis and pulmonary embolism; acute coronary syndromes
    • Administration: subcutaneous injection into the anterolateral or posterolateral abdominal wall, alternating sides
    • Storage: store below 25°C; do not freeze. Ambient distribution - no cold chain required
    • Therapeutic area: antithrombotic agents
  • Selling Points
    • Three delivery presentations: pre-filled syringe, cartridge and disposable pen
    • Ambient storage below 25°C - no cold chain required in distribution
    • WHO-GMP and Schedule M manufacture in India
    • In-house sterile fill-finish
    • Complete CTD/eCTD dossier (Modules 1-5, ICH M4) with ICH Q1A stability data for partner registrations
    • Country-specific Module 1 adaptation
    • Dossier access and samples for qualified partners under CDA
  • Model
    Low molecular weight heparin - anticoagulant injection
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Sales Markets
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Regenix drugs Ltd

  • Country/Region:
    India
  • Founded:
    2006
  • On CPHI since:
    2024
  • Certificates:
    2
  • Employees:
    50 - 99
Company types
Biopharmaceutical company
Generics/Biosimilars Manufacturer
Primary activities
Biopharmaceutical
Pharmaceutical Company (generic finished products)
View company profile

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