Active Pharmaceutical Ingredient

Rupatadine Fumarate — CAS 158876-82-5

Also known as: Rupafin Fumarate; UR-12592 Fumarate

GMP Certified IP / BP / EP / USP Antihistamine / PAF Antagonist Aurangabad, India
Rupatadine Fumarate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Rupatadine Fumarate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 158876-82-5

Product Overview

Rupatadine Fumarate is a high-purity Active Pharmaceutical Ingredient (API) classified under Antihistamine / PAF Antagonist. Mediocon Inc manufactures GMP-compliant Rupatadine Fumarate at its state-of-the-art facility in Aurangabad, Maharashtra, India, supplying pharmaceutical companies worldwide with consistent quality and full regulatory documentation.

Therapeutic Applications
  • Seasonal and perennial allergic rhinitis
  • Chronic spontaneous urticaria
  • H1 antihistamine with platelet-activating factor (PAF) antagonism
  • Allergic inflammatory conditions

Technical Specifications

ParameterSpecification
CAS Number158876-82-5
Molecular FormulaC₂₆H₂₆ClN₃ · C₄H₄O₄
Molecular Weight532.01 g/mol
GradeIP / BP / EP / USP
CategoryAntihistamine / PAF Antagonist
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 NoRUF/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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