Active Pharmaceutical Ingredient

Regorafenib — CAS 755037-03-7

Also known as: BAY 73-4506; Stivarga

GMP Certified IP / BP / EP / USP Multikinase Inhibitor / Antineoplastic Agent Aurangabad, India
Regorafenib API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Regorafenib IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 755037-03-7

Product Overview

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

Therapeutic Applications
  • Metastatic colorectal cancer (mCRC) treatment
  • Hepatocellular carcinoma (HCC) therapy
  • Gastrointestinal stromal tumours (GIST)
  • Multi-targeted kinase inhibition (VEGFR, RAF, PDGFR)

Technical Specifications

ParameterSpecification
CAS Number755037-03-7
Molecular FormulaC₂₁H₁₅ClF₄N₄O₃
Molecular Weight482.82 g/mol
GradeIP / BP / EP / USP
CategoryMultikinase Inhibitor / Antineoplastic 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 NoREGO/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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