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Crizotinib Structure

Product Type

Active Pharmaceutical Ingredient (API)

Grade

USP / BP / EP (as applicable)

Chemical Name

Crizotinib

Chemical Formula

C₂₁H₂₂Cl₂FN5O

Molecular Weight

~450.34 g/mol

CAS Number

877399-52-5

IUPAC Name

3-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethyl]-5-(1-piperidin-4-yl-1H-pyrazol-3-yl)pyridin-2-amine

Chemical Class

Kinase inhibitor

Therapeutic Class

Antineoplastic / Targeted cancer therapy

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance White to off-white crystalline powder
Solubility Practically insoluble in water at neutral pH but becomes freely soluble in acidic conditions
Melting Point 172°C to 184°C
pH 1-3

Product Description

Crizotinib is a targeted cancer drug, specifically a tyrosine kinase inhibitor (TKI), used mainly for ALK-positive non-small cell lung cancer.

How Crizotinib Works

Crizotinib’s mechanism involves blocking abnormal signals from ALK, ROS1, and MET proteins, which are often overactive in certain cancers, thereby halting tumor growth and promoting cancer cell death. It works by competitively inhibiting ATP binding in these kinases, stopping cell proliferation and survival signals.

Use(s)

Adverse Effects

Why choose Salius for Crizotinib?

  1. Regulatory-Grade Manufacturing Standards
    They maintain stringent WHO GMP standards, with some facilities FDA certified, and follows strict internal QC protocols. Every batch is tested in state-of-the-art labs before release, to ensure consistent quality, safety & efficacy.
  2. Enhancing Cost-Effectiveness Through Large Volume API Utilization
    As an exporter and distributor house, Salius aims to deliver high-quality APIs at competitive prices, a key advantage for cost-sensitive and emerging markets.
  3. Global Export Experience & Documentation Support
    Salius regularly exports APIs, provides regulatory documents (DMF, impurity profiles), and supports filings for international clients—even in stringent regulated markets.
  4. Documents We Provide
  5. Transparency & Trustworthiness
    They present as a government-recognized star export house with strong quality and delivery ratings.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

Crizotinib is synthesized through multi-step organic reactions as a small-molecule tyrosine kinase inhibitor, classified under kinase inhibitors targeting ALK, ROS1, and MET pathways.

The API has limited aqueous solubility, so solubility-enhancing techniques like salt formation, micronization, or solid dispersions are often used in oral dosage forms.

High-performance liquid chromatography (HPLC) and chiral analysis are used to quantify assay, related impurities, and confirm enantiomeric purity as per USP/EP/BP standards.

Export requires GMP-compliant manufacturing, detailed stability data, batch-wise CoA, MSDS, and DMF/CTD documentation to facilitate approvals in global markets including US, EU, LATAM, MENA, and Africa.

Place an Order or Request a Quote from Salius Pharma

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