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Summary Of Halofuginone-FDF

Chemical Name

Halofuginone

CAS No.

55837-20-2

Molecular Formula

C16H17BrClN3O3

Innovator

Developer

Indication

Duchenne Muscular Dystrophy

Therapeutic Area

Congenital & Hereditary Disease

Market Status

Vet Launched

Approval Year

Patent Expiry

Looking for Halofuginone detailed analysis?

Chemxpert provides a consolidated intelligence snapshot for Halofuginone, covering its technical profile, commercial footprint, global Halofuginone supplier, Halofuginone buyer and Halofuginone 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 Halofuginone

Halofuginone 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 Halofuginone

The data on this section reflects the sales performance of Halofuginone–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 Halofuginone in major drug markets.

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

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

Global Supplier Landscape for Halofuginone

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

Data covered in this section includes:

  • Halofuginone Suppliers: Companies involved in the manufacturing or commercial supply of Halofuginone as an active pharmaceutical ingredient.
  • Supplying Volume: An indicator of the quantity of Halofuginone supplied by manufacturers, used to assess production scale and supply capacity.
  • Supplier Country Presence: Geographic distribution of Halofuginone 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.
  • Halofuginone Verified Supplier Contact Information: Validated business contact details of Halofuginone 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 Halofuginone, enabling direct manufacturer and distributor intelligence. Our dashboard contains data on:

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

Buyer & Demand Intelligence for Halofuginone

On the demand side, Halofuginone 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 Halofuginone buyer contact records

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

For more insights on Halofuginone FDF commercial and market indicators click here.

Regulatory Filings & Market Authorization for Halofuginone

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

Halofuginone 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 Halofuginone as an API.
  • FDA National Drug Code (NDC): Unique identifier assigned to finished pharmaceutical products marketed in the United States containing Halofuginone.
  • Certificate of Suitability (CEP/COS): Certification issued by EDQM confirming Halofuginone 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 Halofuginone 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 Halofuginone 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 Halofuginone Counterparties

This section presents the geographic spread of Halofuginone 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 Halofuginone FDF Regulatory Filings, Market Authorization, Commercial Intelligence, and Geographic Distribution. Click Here

Clinical, Patent & Compliance Intelligence for Halofuginone

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

Clinical Trial Activity

Clinical trial data reflects ongoing and completed studies involving Halofuginone-based products across the US, Europe, Asia-Pacific, and India. This information helps users assess research intensity, therapeutic relevance, and lifecycle maturity of Halofuginone. Chemxpert tracks Halofuginone 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 Halofuginone.

  • Patent Expiry: Indicates when patent protection related to Halofuginone 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 Halofuginone.

  • 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 Halofuginone

Chemxpert continuously monitors regulatory risk signals related to Halofuginone, 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 Halofuginone FDF Clinical, Patent & Compliance Intelligence,Certifications & Accreditations, Warnings and alert Click here

Biosimilar & Agrochemical Regulatory Status for Halofuginone

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

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

Why Use Chemxpert for Halofuginone 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.