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Summary Of Melphalan-FDF

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Chemical Name

Melphalan

CAS No.

148-82-3

Molecular Formula

C13H18Cl2N2O2

Innovator

Developer

Indication

Multiple Myeloma; Ovarian Cancer

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

Looking for Melphalan detailed analysis?

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

Melphalan 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 Melphalan

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

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

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

Global Supplier Landscape for Melphalan

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

Data covered in this section includes:

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

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

Buyer & Demand Intelligence for Melphalan

On the demand side, Melphalan 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 Melphalan buyer contact records

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

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

Regulatory Filings & Market Authorization for Melphalan

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

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

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

Clinical, Patent & Compliance Intelligence for Melphalan

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

Clinical Trial Activity

Clinical trial data reflects ongoing and completed studies involving Melphalan-based products across the US, Europe, Asia-Pacific, and India.

Patent & Exclusivity Landscape

  • Patent Expiry: Scheduled end of patent protection.
  • Market Exclusivity: Regulatory exclusivity independent of patents.
  • Supplementary Protection Certificates (SPCs)
  • Paragraph IV Filings: Patent challenges signaling generic entry.
  • Patent Disputes & Data Protection

Certifications & Accreditations

  • US FDA Certification
  • EU GMP Certification
  • PMDA (Japan)
  • ANVISA (Brazil)
  • CDSCO, WHO-GMP, PIC/S (India)

Regulatory Warnings & Compliance Signals

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

Get detailed insight into Melphalan FDF Clinical, Patent & Compliance Intelligence.

Biosimilar & Agrochemical Regulatory Status for Melphalan

Chemxpert tracks biosimilar and agrochemical regulatory activity related to Melphalan, where applicable, across global markets.

Get detailed insight into Melphalan FDF Biosimilar & Agrochemical Regulatory Intelligence.

Why Use Chemxpert for Melphalan 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.