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Summary Of Crofelemer-FDF

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Chemical Name

Crofelemer

CAS No.

148465-45-6

Molecular Formula

C18H16N2O3

Innovator

Developer

Indication

Chemotherapy Related Diarrhea

Therapeutic Area

Chemically & Environmental Induced Disorders

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 Crofelemer detailed analysis?

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

Crofelemer 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 Crofelemer

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

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

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

Global Supplier Landscape for Crofelemer

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

Data covered in this section includes:

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

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

Buyer & Demand Intelligence for Crofelemer

On the demand side, Crofelemer 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 Crofelemer buyer contact records

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

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

Regulatory Filings & Market Authorization for Crofelemer

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

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

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

Clinical, Patent & Compliance Intelligence for Crofelemer

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

Clinical Trial Activity

Clinical trial data reflects ongoing and completed studies involving Crofelemer-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 Crofelemer FDF Clinical, Patent & Compliance Intelligence.

Biosimilar & Agrochemical Regulatory Status for Crofelemer

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

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

Why Use Chemxpert for Crofelemer 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.