Active Pharmaceutical Ingredient

Sofigatran — CAS 187602-11-5

Also known as: Sofigatran; TGN255

GMP Certified IP / BP / EP / USP Anticoagulant / Direct Thrombin Inhibitor Aurangabad, India
Sofigatran API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sofigatran IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 187602-11-5

Product Overview

Sofigatran is a direct thrombin inhibitor developed for anticoagulation therapy. It acts by selectively inhibiting thrombin activity to prevent blood clotting in thromboembolic disorders. Mediocon Inc manufactures GMP-compliant Sofigatran API at its Aurangabad facility to international pharmacopoeial standards.

Therapeutic Applications
  • Anticoagulation therapy
  • Thromboembolic disorder prevention
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism management

Technical Specifications

ParameterSpecification
CAS Number187602-11-5
Molecular FormulaC₂₅H₂₄N₄O₅
Molecular Weight476.49 g/mol
GradeIP / BP / EP / USP
CategoryAnticoagulant / Direct Thrombin Inhibitor
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoSG/25030249
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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