Active Pharmaceutical Ingredient

Sevelamer Hydrochloride — CAS 112665-43-7

Also known as: Renagel / Renvela Active

GMP Certified IP / BP / EP / USP Phosphate Binder / Renal Aurangabad, India
Sevelamer Hydrochloride API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sevelamer Hydrochloride IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 112665-43-7

Product Overview

Sevelamer Hydrochloride is a non-absorbable, calcium-free, metal-free phosphate-binding polymer used in patients with chronic kidney disease (CKD) on dialysis. It binds dietary phosphate in the gastrointestinal tract, reducing serum phosphorus levels and preventing hyperphosphatemia complications such as cardiovascular calcification. As a cross-linked polymer, it is not systemically absorbed. Mediocon Inc supplies GMP-certified Sevelamer Hydrochloride API meeting pharmacopoeial standards.

Therapeutic Applications
  • Chronic Kidney Disease (CKD) hyperphosphatemia
  • Dialysis patients — phosphate control
  • Prevention of vascular calcification
  • Tablet/powder oral formulations

Technical Specifications

ParameterSpecification
CAS Number112665-43-7
Molecular FormulaCrosslinked poly(allylamine·HCl)
Molecular WeightPolymer (avg ~9,000 Da)
GradeIP / BP / EP / USP
CategoryPhosphate Binder / Renal
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
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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