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Summary Of Docetaxel-FDF

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Chemical Name

Docetaxel

CAS No.

114977-28-5, 125354-16-7

Molecular Formula

C43H53NO14

Innovator

Developer

Indication

Early Stage Breast Carcinoma; Esophageal Cancer; Esophageal Squamous Cell Carcinoma; Gastroesophageal Junction Adenocarcinoma; Metastatic Castration Resistant Prostate Cancer; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma

Therapeutic Area

Oncology

Market Status

Launched

Approval Year

Patent Expiry

Technology Info
Commercial Info
Supplier Info
Buyer Info

Clinical Trial
Patent
Certification/ Accreditation
Warning/Alert
Biosimilar
Agrochemicals

Detailed Summary of Docetaxel FDF

Chemxpert provides a consolidated intelligence snapshot for Docetaxel FDF, covering its technical profile, commercial footprint, global Docetaxel supplier, Docetaxel buyer and Docetaxel manufacturer dynamics, and regulatory presence across key pharmaceutical markets.

Innovator and developer details, where available, are reflected based on verified disclosures within Chemxpert’s pharmaceutical database.

Technical & Application Intelligence for Docetaxel

Docetaxel technical and applicaiton information includes information on the industry and end-use applications, helping users understand its role across different formulation and therapeutic contexts. The data also covers routes of synthesis and manufacturing technologies, offering visibility into production methods, process variability, and technical complexity.

In addition, the mechanism of action, which describes how it produces its therapeutic effect at the molecular or biological level in the body. This data is documented to support scientific

Commercial & Market Indicators for Docetaxel

The data on this section reflects the sales performance of Docetaxel–based products across key pharmaceutical markets, including regulated regions such as the United States and the United Kingdom, where information is available. It helps users understand regional demand trends, market maturity, and commercial presence of Docetaxel in major drug markets.

Chemxpert aggregates commercial indicators to help assess the global market positioning of Docetaxel.

  • Global market size is tracked in both volume (metric tonne) and value USD.
  • Pricing intelligence includes average Docetaxel FDF price benchmarks (USD/kg) derived from multiple verified sources.
  • Regional Docetaxel sales performance, including markets such US and UK is monitored where data is available.

Global Supplier Landscape for Docetaxel

This section provides intelligence on the Docetaxel global supply ecosystem, helping users identify manufacturers, assess supply scale, and evaluate regulatory readiness.

Data covered in this section includes:

  • Docetaxel Suppliers: Companies involved in the manufacturing or commercial supply of Docetaxel as an active pharmaceutical ingredient.
  • Supplying Volume: An indicator of the quantity of Docetaxel supplied by manufacturers, used to assess production scale and supply capacity.
  • Supplier Country Presence: Geographic distribution of Docetaxel suppliers across countries, helping evaluate regional concentration and supply diversification.
  • Supplier Regulatory Certifications: Information on regulatory approvals and certifications held by supplier manufacturing facilities, such as GMP or FDA compliance, relevant for regulated market sourcing.
  • Docetaxel Verified Supplier Contact Information: Validated business contact details of Docetaxel suppliers, enabling direct communication for sourcing and qualification purposes.

Together, this supplier intelligence supports supplier discovery, qualification, diversification planning, and supply risk assessment.

Chemxpert maps an extensive global supplier ecosystem for Docetaxel, enabling direct manufacturer and distributor intelligence. Our dashboard contains data on:

  • Docetaxel active suppliers around the world
  • Docetaxel total supplying volume
  • Supplier presence across the countries
  • Docetaxel suppliers with regulatory certifications such as GMP, FDA
  • Verified Docetaxel supplier contact records

Buyer & Demand Intelligence for Docetaxel

On the demand side, Docetaxel buyer supplier data intelligence helps you tracks global procurement activities. We provide data such as:

  • Total identified buyers across the globe
  • Total buying volume in metric tonne
  • Buyer presence across the countries
  • Total number of certified buyers
  • Verified Docetaxel buyer contact records

This intelligence enables demand mapping, partner discovery, and market entry evaluation.

For more insights on Docetaxel FDF commercial and market indicators Click here

Regulatory Filings & Market Authorization for Docetaxel

This section provides a comprehensive view of the regulatory status and approval footprint of Docetaxel across major global pharmaceutical markets. It helps users understand where Docetaxel is filed, registered, approved, or authorized for commercial use.

Docetaxel Filings & Registrations

The data provided under the regulatory filings and market authorization section includes:

  • US Drug Master File (US-DMF): Confidential submission to the US FDA covering manufacturing, quality, and control of Docetaxel as an API.
  • FDA National Drug Code (NDC): Unique identifier assigned to finished pharmaceutical products marketed in the United States containing Docetaxel.
  • Certificate of Suitability (CEP/COS): Certification issued by EDQM confirming Docetaxel compliance with the European Pharmacopoeia.
  • EU Molecule Registration: Registration with European regulatory authorities confirming EU manufacturing and supply compliance.
  • UK-MHRA Registration: Authorization by the UK Medicines and Healthcare products Regulatory Agency.
  • REACH Registration: Chemical safety registration under EU REACH regulations.
  • Written Confirmation: GMP compliance confirmation issued by non-EU authorities.

Asia-Pacific & Other Regional Filings

  • Japan Drug Master File (J-DMF): Regulatory filing submitted to Japan’s PMDA.
  • Korea Drug Master File (K-DMF): Dossier submitted to Korea’s MFDS.
  • India Import Licence: Authorization permitting import of Docetaxel into India.
  • China Registration: Regulatory approval for manufacturing, import, or commercial supply in China.
  • Other Regional Registrations: Market-specific approvals across the Middle East, Africa, and Latin America.

Finished Dosage Form (FDF) Filings & Market Authorization

Chemxpert tracks FDF filings, registrations, and market authorizations for products containing Docetaxel across:

  • North America
  • Europe
  • Oceania
  • Africa
  • Asia
  • South America

This data helps users assess downstream product presence, commercialization status, and regional market access.

Geographic Distribution of Docetaxel Counterparties

This section presents the geographic spread of Docetaxel suppliers and buyers across global pharmaceutical markets. Country-level distribution is dynamically updated based on Chemxpert’s live database.

  • North America
  • Europe (Northern / Western, Southern, Eastern)
  • Asia
  • Africa
  • Middle East
  • South America
  • Oceania

Country-level counts are dynamically populated to reflect real-time database coverage.

Get detailed insights on Docetaxel FDF Regulatory Filings, Market Authorization, Commercial Intelligence, and Geographic Distribution.Click here

Clinical, Patent & Compliance Intelligence for Docetaxel

This section provides insight into research activity, intellectual property status, and regulatory compliance landscape associated with Docetaxel.

Clinical Trial Activity

Clinical trial data reflects ongoing and completed studies involving Docetaxel-based products across the US, Europe, Asia-Pacific, and India. This information helps users assess research intensity, therapeutic relevance, and lifecycle maturity of Docetaxel. Chemxpert tracks Docetaxel clinical trial activity across major regions, including the US, Europe, Asia-Pacific, and India, providing insight into research intensity and lifecycle maturity.

Patent & Exclusivity Landscape

Patent intelligence provides visibility into the intellectual property protections and competitive barriers associated with Docetaxel.

  • Patent Expiry: Indicates when patent protection related to Docetaxel or its formulations is scheduled to end.
  • Market Exclusivity: Regulatory exclusivity periods granted independently of patents, restricting generic competition for a defined time.
  • Supplementary Protection Certificates (SPCs) Extensions of patent protection in certain regions to compensate for regulatory approval timelines.
  • Paragraph IV Filings: Legal filings challenging existing patents, often signaling potential generic entry.
  • Patent Disputes & Data Protection Information on ongoing litigation, disputes, or regulatory data protection that may impact market access.

This intelligence supports freedom-to-operate assessments and generic launch planning.

Certifications & Accreditations

This dataset captures regulatory certifications held by manufacturing facilities involved with Docetaxel.

  • US FDA Certification - Indicates compliance with US regulatory standards
  • EU GMP Certification - Confirms adherence to European Good Manufacturing Practices
  • PMDA (Japan) - Approval by Japanese regulatory authorities
  • ANVISA (Brazil) - Compliance with Brazilian regulatory requirements
  • CDSCO, WHO-GMP, PIC/S (India) - Certifications demonstrating compliance with Indian and international quality standards

These certifications help users evaluate supplier compliance, audit readiness, and suitability for regulated markets.

Regulatory Warnings & Compliance Signals Docetaxel

Chemxpert continuously monitors regulatory risk signals related to Docetaxel, including:

  • FDA warnings and recalls
  • Form 483 observations
  • Site inspection records
  • Country-specific bans, price controls, and essential medicine listings

These signals help stakeholders proactively manage compliance and sourcing risks.

Get the detail insight about Docetaxel FDF Clinical, Patent & Compliance Intelligence,Certifications & Accreditations, Warnings and alertClick here

Biosimilar & Agrochemical Regulatory Status for Docetaxel

Chemxpert also tracks biosimilar and agrochemical regulatory activity related to Docetaxel, where applicable, across global markets. Current filing and approval status is dynamically reflected based on regulatory disclosures.

Get detailed insight into Docetaxel FDF Biosimilar & Agrochemical Regulatory Intelligence.Click here

Why Use Chemxpert for Docetaxel Intelligence?

Chemxpert combines supplier data, regulatory depth, commercial indicators, and compliance intelligence into a single, continuously updated platform—helping pharmaceutical companies, buyers, and regulators make faster and better-informed decisions.