Sorafenib Tosylate API
| Name of Product | Sorafenib |
|---|---|
| CAS No | 284461-73-0 |
| Therapeutic use:- | Anti Cancer |
| Grade | BP/USP |
| Form:- | API Powder |
| Status | Commercial |
Product Overview
Sorafenib is an orally active multi-kinase inhibitor a bis-aryl urea that inhibits several receptor tyrosine kinases and RAF serine/threonine kinases involved in tumour cell proliferation and angiogenesis.
It was among the first targeted oncology agents to reach broad global use and remains a standard option across several solid tumour indications.
The commercial form is sorafenib tosylate the p-toluenesulfonate salt, molecular weight 637.03 against 464.82 for the free base.
Dosage strengths are expressed as sorafenib base equivalent, so the basis on which your specification and assay are written matters.
We supply the tosylate salt unless the free base is specifically requested.
Actiza Pharmaceutical manufactures Sorafenib Tosylate API in Pharma Grade, in a dedicated contained oncology manufacturing block at our WHO-GMP certified facility in Surat, Gujarat, India.
Material is available in standard and micronised grades with controlled polymorphic form and defined particle size distribution.
Two things separate credible suppliers on this molecule: containment capability appropriate to a hazardous oncology compound, and control of the aniline-derived genotoxic impurities that come with the synthetic route.
Both are audited early in qualification, and both are addressed in our standard technical package.
Key Highlights and Certifications
Applications & Use Cases
Sorafenib Tosylate is formulated into oral solid dosage forms.
It has very low aqueous solubility with high permeability, which places it in BCS Class II meaning dissolution, and therefore bioavailability, is directly governed by particle size and crystal form rather than by chemical purity alone.
Formulation Types
Film-coated tablets with strengths expressed as sorafenib base equivalent
Solubility-enhanced and amorphous solid dispersion development formulations
Bioequivalence and generic development batches
Therapeutic Areas Served by the Finished Formulations
Advanced renal cell carcinoma
Unresectable hepatocellular carcinoma
Differentiated thyroid carcinoma refractory to radioactive iodine, where locally approved
Buyer Segments We Supply
Oncology formulation manufacturers with contained handling capability
CDMOs and contract manufacturers running dedicated oncology lines
Generic developers preparing bioequivalence and registration batches
Regulated and semi-regulated market importers and distributors
Research institutions and analytical laboratories requiring characterised material
Technical Specifications
| Parameter | Specification |
| Product Name | Sorafenib Tosylate |
| Chemical Name (IUPAC) | 4-[4-[[4-Chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide 4-methylbenzenesulfonate |
| CAS Number | 475207-59-1 (tosylate salt) 284461-73-0 (sorafenib free base) |
| Molecular Formula | C21H16ClF3N4O3 · C7H8O3S |
| Molecular Weight | 637.03 g/mol (tosylate) 464.82 g/mol (free base) |
| Salt Form | p-Toluenesulfonate (tosylate). Dosage strengths are expressed as sorafenib base equivalent |
| Therapeutic Category | Multi-kinase inhibitor oncology |
| Hazard Classification | Hazardous / high-potency oncology compound; contained handling required at manufacture and at your site |
| Grade | Pharma Grade standard and micronised |
| Appearance | White to off-white or pale yellowish crystalline powder |
| Identification | Complies by IR, UV and HPLC retention time against working standard |
| Polymorphic Form | Form as per agreed specification confirmed by XRD on every batch |
| Assay (HPLC) | Available on request |
| Related Substances / Impurities | Individual and total impurities within specification limits; known and specified impurities controlled and reported |
| Genotoxic / Mutagenic Impurities | Aniline-derived starting material and intermediate residues assessed and controlled as per ICH M7, with limits and per-batch results in the technical package |
| Nitrosamine Impurities | Risk assessment completed as per EMA / USFDA guidance |
| Particle Size Distribution | D10 / D50 / D90 as per agreed specification micronised grade available to buyer requirement |
| Residual Solvents | Complies with ICH Q3C; Class 1 solvents absent |
| Elemental Impurities | Complies with ICH Q3D risk assessment |
| Water Content (KF) | Available on request |
| Residue on Ignition / Sulphated Ash | Available on request |
| Solubility | Practically insoluble in water; very slightly soluble in ethanol; soluble in dimethyl sulfoxide- BCS Class II behaviour |
| Bulk / Tapped Density | Available on request |
| Storage Condition | Store in tight, light-resistant containers at controlled room temperature; protect from light and moisture; store in a segregated area appropriate to a hazardous compound |
| Shelf Life / Retest Period | Available on request |
| HS Code | Available on request |
Regulatory & Documentation Support
Oncology APIs carry a heavier documentation load than conventional products, and buyers qualify suppliers on containment evidence as much as on the regulatory file.
Regulatory Status
Impurity Control Documentation
The synthetic route to sorafenib passes through a substituted aniline, which places genotoxic impurity control at the centre of the review. We supply this proactively:
ICH M7 assessment with classification of actual and potential mutagenic impurities
Control strategy and specification limits for aniline-derived starting material and intermediate residues
Per-batch analytical results for specified genotoxic impurities, with methods and validation summaries
Nitrosamine risk assessment as per EMA / USFDA guidance
Impurity profile with identification and qualification data for specified impurities
Containment & Cross-Contamination Evidence
For a hazardous oncology compound this is audited early and specifically:
Manufacture in a dedicated contained oncology block with segregated material flow
Cleaning validation and cleaning verification data available under a confidentiality agreement
Segregation from non-oncology production, with dedicated gowning, personnel flow and air handling controls
Occupational exposure controls documented as part of the site EHS system
Customer audits of the oncology area welcomed as part of supplier qualification
Documents Supplied With Every Consignment
Certificate of Analysis (COA), batch-specific
Material Safety Data Sheet (MSDS / SDS) in GHS format, including hazardous-compound handling guidance
GMP Certificate and Manufacturing Licence copy
Certificate of Origin and Free Sale Certificate (on request)
Method of Analysis (MOA) and specification sheet
XRD data confirming polymorphic form, and particle size distribution report
Genotoxic impurity and nitrosamine assessment statements with per-batch data
Stability data accelerated and long-term, as per ICH Q1A
Residual solvent and elemental impurity statements
Non-BSE/TSE, allergen-free, GMO-free and melamine-free declarations
Packing list, invoice and shipping documents as per the agreed Incoterm
Packaging, MOQ & Logistics
| Detail | Offering |
| Primary Packaging | Double LDPE liner (pharma grade) with TIP tie closure, packed under contained conditions |
| Secondary Packaging | HDPE drum / triple-laminated aluminium bag with tamper-evident seals light and moisture barrier, labelled for hazardous compound handling |
| Standard Pack Sizes | Available on request |
| Minimum Order Quantity (MOQ) | Available on request for commercial orders; smaller quantities for bioequivalence and development batches |
| Sample Quantity | Available on request for evaluation, subject to documentation and confirmation of containment capability at your site |
| Lead Time | Available on request |
| Shipping Terms | EXW, FOB, CIF, CFR, DDP as agreed |
| Mode of Shipment | Air freight preferred given product value; tamper-evident sealing and hazardous-compound labelling throughout |
| Storage & Handling | Store at controlled room temperature in original sealed packaging in a segregated area, protected from light and moisture. Handle with the personal protective equipment and containment specified in the SDS; avoid dust generation during weighing and transfer |
Why Choose Actiza Pharmaceutical
Containment appropriate to an oncology compound.
Sorafenib is handled as a hazardous product from synthesis through packing, in a dedicated contained block segregated from non-oncology manufacturing, with validated cleaning and documented occupational exposure controls.
This is the first thing a buyer’s QA team audits, and it is not something a general-purpose plant can arrange for a single order.
Genotoxic impurity control demonstrated with data. The route runs through a substituted aniline, so ICH M7 control is a certainty in review rather than a possibility.
We supply the assessment, the control strategy, the limits and the per-batch results as part of the standard package not three weeks after a deficiency letter arrives.
Physical form control for a BCS Class II product. Polymorphic form confirmed by XRD every batch and particle size distribution manufactured to your agreed specification.
When your commercial objective is bioequivalence, these are the parameters that determine whether you get there.
Quality systems that survive an audit. WHO-GMP and ISO 9001:2015 certified operations with a documented QMS covering change control, deviation handling, CAPA and annual product quality reviews.
Analytical depth in-house. HPLC, LC-MS, GC, XRD, particle size analyser, UV, FTIR and Karl Fischer instrumentation, with trace-level methods for genotoxic impurities and method transfer support for your QC laboratory.
Development-scale flexibility. Bioequivalence and registration batches often need kilograms, not tonnes. We supply development quantities on realistic timelines rather than treating small orders as an inconvenience.
Frequently Asked Questions
Do you supply sorafenib as the tosylate salt or the free base?
We supply sorafenib tosylate (CAS 475207-59-1), which is the commercial form, unless the free base (CAS 284461-73-0) is specifically requested.
The molecular weights differ substantially 637.03 against 464.82 and finished dosage strengths are expressed as sorafenib base equivalent, so please confirm which basis your specification and assay limits are written against.
Is a DMF available for Sorafenib Tosylate API?
Yes. A Drug Master File is on record for this product. We share the DMF reference number and issue a Letter of Access directly to the buyer once an NDA is in place.
Write to our regulatory desk with your destination market and dosage form, and we will confirm what is available for your territory, including any applicable certificate of suitability or Written Confirmation where applicable.
Is the product manufactured under containment?
Yes. Sorafenib is handled as a hazardous oncology compound in a dedicated contained block with segregated material flow, dedicated gowning and personnel controls, and validated cleaning.
Containment documentation and cleaning validation data can be shared under a confidentiality agreement, and we welcome customer audits of the area as part of supplier qualification.
How are genotoxic impurities controlled?
The synthetic route passes through a substituted aniline, so mutagenic impurity control is central to the file rather than incidental.
We supply an ICH M7 assessment with classification, a documented control strategy, specification limits and per-batch analytical results, along with the trace-level methods and validation summaries for transfer to your QC laboratory.
Which polymorphic form do you supply?
We supply the form agreed in your specification, confirmed by X-ray diffraction on every batch, with XRD data released alongside the COA.
Sorafenib tosylate is known to exist in more than one crystalline form, so if your filing requires a specific one, raise it at enquiry stage and confirm the intellectual property position for your target market with your own counsel.
Can you supply micronised material to a specific particle size?
Yes. Standard and micronised grades are available, manufactured to your agreed D10 / D50 / D90 specification. Sorafenib tosylate is BCS Class II with very low aqueous solubility, so particle size directly governs dissolution and bioavailability share your target PSD and dissolution profile and we will confirm what we can hold batch to batch.
What quantities do you supply, and do you support development batches?
Our standard commercial MOQ is available on request, with smaller quantities available for bioequivalence, registration and development work this is a high-value product and development programmes typically need kilograms rather than tonnes.
Evaluation samples are supplied subject to documentation and confirmation that your site has appropriate containment capability.
What is the patent position in our market?
Patent and data exclusivity positions for this molecule differ by jurisdiction and change over time.
We do not advise on freedom to operate and this page should not be read as doing so confirm the position for your destination market with your own intellectual property counsel before committing to a development or launch timeline.
Which countries do you currently export to?
We supply buyers across several regions. Share your destination market and we will confirm our regulatory readiness for it.
What documents are provided with each shipment?
Batch-specific COA, MSDS with hazardous-compound handling guidance, GMP certificate, Certificate of Origin, method of analysis, XRD and particle size reports, genotoxic impurity and nitrosamine statements with per-batch data, stability summary, and the standard regulatory declarations.
Request a Quote for Sorafenib Tosylate API
Tell us your required quantity, grade (standard or micronised), target particle size, polymorphic form requirement, destination market and preferred Incoterm we will revert with pricing, lead time and the complete document set promptly.