Active Pharmaceutical Ingredient

Sorafenib API Manufacturer & Supplier in India

Also known as: Nexavar; BAY 43-9006

GMP Certified IP / BP / EP / USP Anticancer / Kinase Inhibitor Aurangabad, India
Sorafenib API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sorafenib IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 284461-73-0

Product Overview

Sorafenib is an oral multikinase inhibitor that targets multiple receptor tyrosine kinases (VEGFR, PDGFR) and Raf kinases. It is used in the treatment of hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid cancer. Mediocon Inc manufactures GMP-compliant Sorafenib API at its Aurangabad facility to international pharmacopoeial standards.

Therapeutic Applications
  • Hepatocellular carcinoma (HCC)
  • Renal cell carcinoma (RCC)
  • Differentiated thyroid carcinoma
  • Multi-kinase targeted cancer therapy

Technical Specifications

ParameterSpecification
CAS Number284461-73-0
Molecular FormulaC₂₁H₁₆ClF₃N₄O₃
Molecular Weight464.83 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 NoSF/25030252
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

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Sorafenib — CAS 284461-73-0 (CAS 284461-73-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sorafenib — CAS 284461-73-0 is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Sorafenib — CAS 284461-73-0 API

What is the minimum order quantity for Sorafenib — CAS 284461-73-0 API?
Mediocon Inc supplies Sorafenib — CAS 284461-73-0 with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Sorafenib — CAS 284461-73-0 does Mediocon supply?
We supply Sorafenib — CAS 284461-73-0 conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Sorafenib — CAS 284461-73-0 API?
Every shipment of Sorafenib — CAS 284461-73-0 comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Sorafenib — CAS 284461-73-0 bulk orders?
Standard lead time for Sorafenib — CAS 284461-73-0 is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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