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Gefitinib API

Name of Product Gefitinib
CAS No 184475-35-2
Therapeutic use:- Anti Cancer
Grade BP/USP
Form:- API Powder
Status Commercial
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We are a 100% export-oriented company and do not engage in domestic sales within India.

Product Overview

Gefitinib API is a highly pure active pharmaceutical ingredient.

The API is made with strict quality controls and meets applicable the necessary regulations.

This API is for formulation development, research, and scaling up. 

Therapeutic Applications

Gefitinib API is used to create targeted small-molecule formulations.

It is a key raw material for the manufacture of regulated solid dosage forms.

The API helps create formulations, improve processes, and expand tasks.

It offers high purity and meets clear standards. In advanced pharmaceutical manufacturing, it ensures steady performance.

Specification Parameters

This section explains the quality and control criteria for Gefitinib API in making medicines.

  • Chemical Name (IUPAC): N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinamine

  • CAS Number: 184475-35-2

  • Molecular Formula: Câ‚‚â‚‚Hâ‚‚â‚„ClFNâ‚„O₃

  • Molecular Weight: 446.90 g/mol

  • Appearance: A white or off-white powder or crystalline solid.

  • Identification Tests: Compare IR and/or HPLC with the reference standard.

  • Assay Method: HPLC is used to determine content and purity.

  • Assay (Purity): Typically not less than 99.0% by HPLC.

  • Related Substances: Managed by HPLC impurity profile limits.

  • Residual Solvents: Comply with ICH Q3C guidelines.

  • Elemental Impurities: Meet ICH Q3D requirements.

  • Loss on Drying / Water Content: Maintained at a low level as per specifications.

  • Polymorphic Form: It is controlled and defined to ensure manufacturing consistency.

  • Microbial Limits: Not needed for non-sterile API; monitored as required.

    Packaging & Storage

    Gefitinib API in bulk is packed in sealed, moisture-resistant containers.

    These can be HDPE or fiber and plastic drums.

    Store in a cool, dry, well-ventilated area to maintain quality.

    It is kept away from direct light, heat, and excess moisture.

    Why Choose Us

    Actiza Pharmaceutial Pvt. Ltd. offers high-quality Gefitinib API.

    We strictly monitor our manufacturing process to maintain a steady supply.

    Quality Focus

    The Gefitinib API is made in controlled systems with strict quality checks.

    We check every batch carefully to ensure it meets the required standards for purity, consistency, and stability.

    Integrated Setup

    We make APIs in-house with our integrated facilities.

    This helps us better control processes, timelines, and documents.

    This helps reduce risks, improve traceability, and maintain consistent quality.

    Modern Facilities

    Actiza Pharma runs modern manufacturing plants.

    These plants are equipped with automated machines and strict cleaning protocols.

    We care about safety, cleanliness, and following global standards.

    Global Support

    Our ordering process is user-friendly, and our customer support team is available 24/7.

    They carefully manage each order to ensure timely shipping and delivery as scheduled.