Active Pharmaceutical Ingredient

Sunitinib Malate — CAS 341031-54-7

Also known as: Sutent Active Ingredient

GMP Certified IP / BP / EP / USP Antineoplastic / Tyrosine Kinase Inhibitor Aurangabad, India
Sunitinib Malate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sunitinib Malate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 341031-54-7

Product Overview

Sunitinib Malate is the malate salt form of the multi-targeted tyrosine kinase inhibitor Sunitinib, commercially known as Sutent. It demonstrates inhibitory activity against multiple receptor tyrosine kinases including PDGFR-α/β, VEGFR 1/2/3, KIT, FLT3, CSF-1R, and RET. Mediocon Inc supplies GMP-certified Sunitinib Malate API compliant with IP/BP/EP/USP pharmacopoeial standards for global pharmaceutical manufacturers.

Therapeutic Applications
  • Renal Cell Carcinoma treatment
  • Imatinib-resistant GIST
  • Pancreatic neuroendocrine tumors
  • Anti-angiogenic therapy

Technical Specifications

ParameterSpecification
CAS Number341031-54-7
Molecular FormulaC₂₆H₃₁FN₄O₆
Molecular Weight532.55 g/mol
GradeIP / BP / EP / USP
CategoryAntineoplastic / Tyrosine Kinase Inhibitor
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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