Active Pharmaceutical Ingredient

Pentosan Polysulfate Sodium — CAS 116001-96-8

Also known as: PPS Sodium; SP-54; Elmiron (brand); Fibrase (brand)

GMP Certified IP / BP / EP / USP Urological Agent / Anticoagulant Aurangabad, India
Pentosan Polysulfate Sodium API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pentosan Polysulfate Sodium IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 116001-96-8

Product Overview

Pentosan Polysulfate Sodium is a semi-synthetic heparin-like polysaccharide derived from beechwood hemicellulose (xylan). Mediocon Inc manufactures this high-purity API at its GMP-certified facility in Aurangabad, Maharashtra, India. It is the only FDA-approved oral drug for interstitial cystitis (IC) and has anticoagulant and fibrinolytic properties. The compound adheres to the bladder wall, forming a protective layer that reduces inflammation.

Therapeutic Applications
  • Treatment of interstitial cystitis / bladder pain syndrome
  • Anticoagulant and antithrombotic therapy
  • Fibrinolytic adjunct applications
  • Research use in osteoarthritis disease modification

Technical Specifications

ParameterSpecification
CAS Number116001-96-8
Molecular FormulaPolysaccharide Polysulfate Sodium Salt
Molecular Weight~6,000 Da (average)
GradeIP / BP / EP / USP
CategoryUrological Agent / Anticoagulant
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 NoPENT/24032026
Mfg DateMAR 2026
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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