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Summary Of Pitolisant Hydrochloride-API-Small Molecules

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Chemical Name

Pitolisant Hydrochloride

CAS No.

903576-44-3

Molecular Formula

C17H27Cl2NO

Innovator

Developer

Indication

Narcolepsy

Therapeutic Area

Nervous System Disease

Market Status

Launched

Approval Year

Patent Expiry

Looking for Detailed Summary of Pitolisant Hydrochloride?

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

Pitolisant Hydrochloride 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 Pitolisant Hydrochloride.

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

Commercial & Market Indicators for Pitolisant Hydrochloride

Commercial & Market Indicators reflects the sales performance of Pitolisant Hydrochloride–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 Pitolisant Hydrochloride in major drug markets.

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

Global Supplier Landscape for Pitolisant Hydrochloride

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

  • Pitolisant Hydrochloride API Suppliers – Companies involved in the manufacturing or commercial supply of Pitolisant Hydrochloride
  • 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
  • Pitolisant Hydrochloride 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 Pitolisant Hydrochloride

On the demand side, Pitolisant Hydrochloride 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 Pitolisant Hydrochloride API buyer contact records

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

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

Regulatory Filings & Market Authorization for Pitolisant Hydrochloride

Pitolisant Hydrochloride 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 Pitolisant Hydrochloride 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 Pitolisant Hydrochloride Regulatory, Commercial and Geographic Distribution – Click here

Clinical, Patent & Compliance Intelligence for Pitolisant Hydrochloride

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 Pitolisant Hydrochloride Clinical, Patent & Compliance – Click here

Biosimilar & Agrochemical Regulatory Status for Pitolisant Hydrochloride

Chemxpert tracks biosimilar and agrochemical regulatory activity related to Pitolisant Hydrochloride 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 Pitolisant Hydrochloride 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.