Active Pharmaceutical Ingredient

Leflunomide

Also known as: Arava; SU101

CAS: 75706-12-6 DMARD / Immunomodulator IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Leflunomide API — Mediocon Inc
Leflunomide — Pharmaceutical Grade API

Product Overview

CAS No: 75706-12-6  |  MF: C₁₂H₉F₃N₂O₂  |  MW: 270.21 g/mol

Leflunomide is a pharmaceutical-grade active ingredient classified as DMARD / Immunomodulator. Mediocon Inc supplies high-purity Leflunomide API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Pyrimidine synthesis inhibitor DMARD
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Active autoimmune disease management

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameLeflunomide
Also Known AsArava; SU101
CAS Number75706-12-6
Chemical Name5-Methylisoxazol-4-yl-4-trifluoromethylaniline carboxamide
Molecular FormulaC₁₂H₉F₃N₂O₂
Molecular Weight270.21 g/mol
CategoryDMARD / Immunomodulator
AppearanceWhite to off-white powder
SolubilitySlightly soluble in water, soluble in ethanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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