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Summary Of Insulin-FDF

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Chemical Name

Insulin

CAS No.

9004-10-8,

Molecular Formula

C256H381N65O77S6

Innovator

Developer

Indication

Blood Glucose; Diabetes Mellitus Type 1; Diabetes Mellitus Type 2; Glycemic Control

Therapeutic Area

Diagnostic, Therapeutic Techniques & Equipment; Endocrinology

Market Status

--

Approval Year

Patent Expiry

Technology Info
Commercial Info
Supplier Info
Buyer Info

Clinical Trial
Patent
Certification/ Accreditation
Warning/Alert
Biosimilar
Agrochemicals

Detailed Summary of Insulin FDF

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

Insulin 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 Insulin

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

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

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

Global Supplier Landscape for Insulin

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

Data covered in this section includes:

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

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

Buyer & Demand Intelligence for Insulin

On the demand side, Insulin 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 Insulin buyer contact records

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

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

Regulatory Filings & Market Authorization for Insulin

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

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

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

Clinical, Patent & Compliance Intelligence for Insulin

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

Clinical Trial Activity

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

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

  • 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 Insulin

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

Biosimilar & Agrochemical Regulatory Status for Insulin

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

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

Why Use Chemxpert for Insulin 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.