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Summary Of Bivalirudin-API-Small Molecules

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Chemical Name

Bivalirudin

CAS No.

128270-60-0

Molecular Formula

C98H138N24O33

Innovator

Developer

Indication

Thrombocytopenia; Thrombosis

Therapeutic Area

Hematology; Cardiovascular Disease

Market Status

Launched

Approval Year

Patent Expiry

Detailed Summary of Bivalirudin?

Chemxpert provides a consolidated intelligence snapshot for Bivalirudin, covering its technical profile, commercial footprint, global Bivalirudin supplier, Bivalirudin buyer and Bivalirudin manufacturer dynamics, and regulatory presence across key pharmaceutical markets.

Innovator and developer details, where available, are reflected based on verified disclosures within Chemxpert database.

Technical & Application Intelligence for Bivalirudin

Bivalirudin technical & application intelligence 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 describes how an API ingredient produces its therapeutic effect at the molecular or biological level in the body. This data supports scientific understanding, formulation development, and regulatory evaluation of Bivalirudin.

Chemxpert tracks the technical landscape of Bivalirudin across its manufacturing and application ecosystem.

Commercial & Market Indicators for Bivalirudin

Commercial & Market Indicators reflects the sales performance of Bivalirudin–based products across key pharmaceutical markets, including regulated regions such as the United States and the United Kingdom where available. It helps users understand regional demand trends, market maturity, and commercial presence of Bivalirudin in major drug markets.

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

Global Supplier Landscape for Bivalirudin

Bivalirudin global supplier landscape provides intelligence on the API global supply ecosystem, helping users identify manufacturers, assess supply scale, and evaluate regulatory readiness.

  • Bivalirudin API Suppliers – Companies involved in the manufacturing or commercial supply of Bivalirudin
  • Supplying Volume – Indicator of quantity supplied used to assess production scale and capacity
  • Supplier Country Presence – Geographic distribution across countries
  • Supplier Regulatory Certifications – GMP, FDA and other approvals held by facilities
  • Bivalirudin API Verified Supplier Contact Information – Validated business contact details

Together, this supplier intelligence supports supplier discovery, qualification, diversification planning, and supply risk assessment. This dataset supports supplier qualification, diversification planning, and sourcing risk mitigation.

Buyer & Demand Intelligence for Bivalirudin

On the demand side, Bivalirudin API buyer supplier data intelligence tracks global procurement activities.

  • Total identified buyers across the globe
  • Total buying volume in metric tonne
  • Buyer presence across countries
  • Total number of certified buyers
  • Verified Bivalirudin API buyer contact records

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

Get the detailed insight about Bivalirudin technical, commercial, supplier and buyer – Click here

Regulatory Filings & Market Authorization for Bivalirudin

Bivalirudin regulatory filings & market authorization provide a comprehensive view of approval status across global pharmaceutical markets.

  • US Drug Master File (US-DMF)
  • FDA National Drug Code (NDC)
  • Certificate of Suitability (CEP / COS)
  • EU API Registration
  • UK-MHRA Registration
  • REACH Registration
  • Written Confirmation

Asia-Pacific & Other Regional Filings

  • Japan Drug Master File (J-DMF)
  • Korea Drug Master File (K-DMF)
  • India Import Licence
  • China API Registration
  • Other regional registrations (Middle East, Africa, Latin America)

Finished Dosage Form (FDF) Market Authorization

  • North America
  • Europe
  • Oceania
  • Africa
  • Asia
  • South America

Geographic Distribution of Bivalirudin Counterparties

  • 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 the detailed insight about Bivalirudin Regulatory, Commercial and Geographic Distribution – Click here

Clinical, Patent & Compliance Intelligence for Bivalirudin

Clinical Trial Activity

Tracks ongoing and completed trials across the US, Europe, Asia-Pacific and India.

Patent & Exclusivity Landscape

  • Patent expiry
  • Market exclusivity
  • SPC extensions
  • Paragraph IV filings
  • Patent disputes & data protection

Certifications & Accreditations

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

Regulatory Warnings & Compliance Signals

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

Get detailed insight on Bivalirudin Clinical, Patent & Compliance – Click here

Biosimilar & Agrochemical Regulatory Status for Bivalirudin

Chemxpert tracks biosimilar and agrochemical regulatory activity related to Bivalirudin across global markets. A regulatory dashboard reflects filing and approval status in the US, Europe, Japan, India, China and other countries.

Get detailed Biosimilar & Agrochemical Regulatory Insight – Click here

Why Use Chemxpert for Bivalirudin API Intelligence?

Chemxpert combines supplier data, regulatory depth, commercial indicators, US DMF and compliance intelligence into a single continuously updated platform — helping pharmaceutical companies, buyers and regulators make faster and better-informed decisions.