Active Pharmaceutical Ingredient

Sorafenib Tosylate — CAS 475207-59-1

Also known as: Nexavar Tosylate; BAY 43-9006 Tosylate

GMP Certified IP / BP / EP / USP Anticancer / Kinase Inhibitor Aurangabad, India
Sorafenib Tosylate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sorafenib Tosylate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 475207-59-1

Product Overview

Sorafenib Tosylate is the tosylate salt form of Sorafenib, a multikinase inhibitor with enhanced bioavailability used for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, and differentiated thyroid cancer. Mediocon Inc manufactures GMP-compliant Sorafenib Tosylate API at its Aurangabad facility.

Therapeutic Applications
  • Hepatocellular carcinoma (HCC)
  • Renal cell carcinoma (RCC)
  • Thyroid cancer treatment
  • Angiogenesis inhibition

Technical Specifications

ParameterSpecification
CAS Number475207-59-1
Molecular FormulaC₂₈H₂₄ClF₃N₄O₆S
Molecular Weight637.02 g/mol
GradeIP / BP / EP / USP
CategoryAnticancer / 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
Batch NoST/25030253
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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