Active Pharmaceutical Ingredient

Rufinamide — CAS 106308-44-5

Also known as: Banzel; Inovelon; CGP-33101

GMP Certified IP / BP / EP / USP Anticonvulsant / Antiepileptic Agent Aurangabad, India
Rufinamide API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Rufinamide IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 106308-44-5

Product Overview

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

Therapeutic Applications
  • Lennox-Gastaut syndrome (LGS) seizures
  • Adjunctive treatment of tonic and atonic seizures
  • Refractory epilepsy management
  • Sodium channel modulation

Technical Specifications

ParameterSpecification
CAS Number106308-44-5
Molecular FormulaC₁₀H₈F₂N₄O
Molecular Weight238.19 g/mol
GradeIP / BP / EP / USP
CategoryAnticonvulsant / Antiepileptic Agent
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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