Active Pharmaceutical Ingredient

Sunitinib — CAS 557795-19-4

Also known as: Sunitinib Base

GMP Certified IP / BP / EP / USP Antineoplastic / Tyrosine Kinase Inhibitor Aurangabad, India
Sunitinib API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sunitinib IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 557795-19-4

Product Overview

Sunitinib is a multi-targeted receptor tyrosine kinase (RTK) inhibitor used in the treatment of renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors. It exerts its effects by inhibiting PDGFR, VEGFR, KIT, FLT3, CSF-1R, and RET pathways, resulting in anti-tumor and anti-angiogenic activity. Mediocon Inc manufactures pharmaceutical-grade Sunitinib API meeting IP/BP/EP/USP specifications at its GMP-certified facility in Aurangabad, Maharashtra.

Therapeutic Applications
  • Renal Cell Carcinoma (RCC)
  • Gastrointestinal Stromal Tumors (GIST)
  • Pancreatic Neuroendocrine Tumors
  • Multi-targeted RTK inhibition

Technical Specifications

ParameterSpecification
CAS Number557795-19-4
Molecular FormulaC₂₂H₂₇FN₄O₂
Molecular Weight398.47 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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