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Summary Of Propafenone-FDF

Chemical Name

Propafenone

CAS No.

54063-53-5

Molecular Formula

C21H27NO3

Innovator

Developer

Indication

Arrhythmia; Atrial Fibrillation

Therapeutic Area

Cardiovascular Disease

Market Status

Launched

Approval Year

Patent Expiry

Looking for Propafenone detailed analysis?

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

Propafenone 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 Propafenone

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

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

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

Global Supplier Landscape for Propafenone

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

Data covered in this section includes:

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

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

Buyer & Demand Intelligence for Propafenone

On the demand side, Propafenone 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 Propafenone buyer contact records

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

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

Regulatory Filings & Market Authorization for Propafenone

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

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

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

Clinical, Patent & Compliance Intelligence for Propafenone

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

Clinical Trial Activity

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

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

  • 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 Propafenone

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

Biosimilar & Agrochemical Regulatory Status for Propafenone

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

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

Why Use Chemxpert for Propafenone 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.