Bulk Pharmaceutical API Sources for PITOLISANT HYDROCHLORIDE

Bulk Pharmaceutical API Sources for PITOLISANT HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemTik		CTK3G6976
Aurum Pharmatech LLC		W-5436
AbaChemScene		CS-1501
MedChemexpress MCE		HY-12199B
AKos Consulting & Solutions		AKOS024457784
MolPort		MolPort-023-276-920
Tocris Bioscience		3743

Bulk Active Pharmaceutical Ingredient (API) Sources for: Pitolisant Hydrochloride

Last updated: July 28, 2025

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Introduction

Pitolisant hydrochloride (also known by its research code ORP-3100) is a selective histamine H3 receptor antagonist/inverse agonist developed primarily for the treatment of narcolepsy and other sleep disorders. Its mechanism involves increasing histaminergic neurotransmission, promoting wakefulness and alertness. As the demand for pitolisant grows, securing reliable bulk API sources becomes critical for pharmaceutical companies, contract manufacturing organizations (CMOs), and research institutions. Understanding the global supply chain, key manufacturers, and quality considerations for pitolisant hydrochloride API is vital in sourcing high-quality, cost-effective materials.

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Overview of API Sourcing in the Pharmaceutical Industry

The sourcing of APIs like pitolisant hydrochloride involves navigating a complex network of generic and branded manufacturing facilities across various regions—primarily Asia, Europe, and North America. Suppliers must comply with rigorous Good Manufacturing Practice (GMP) standards to ensure product safety, efficacy, and regulatory compliance. Demand-driven factors such as patent landscapes, manufacturing capacity, and regulatory approvals influence API availability and sourcing strategies.

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Global Manufacturers and Suppliers of Pitolisant Hydrochloride API

1. Endo Pharmaceuticals and Partnered Contract Manufacturers

While Endo Pharmaceuticals pioneered the development of pitolisant through its acquisition of the rights for European markets (marketed as "Wakix"), external API manufacturing details remain confidential. However, licencing agreements often involve contract manufacturing organizations capable of producing high-purity APIs in compliance with GMP standards.

2. Specialty Chemical and API Contract Manufacturers

Global CMOs with the capacity to synthesize complex heterocyclic APIs like pitolisant include:

• Rotam Pharmaceuticals: An established CMO offering APIs in the neuropsychiatric and central nervous system (CNS) therapeutic areas. Rotam has a reputation for high-quality manufacturing, including regulatory compliance, making it a potential source for pitolisant hydrochloride, subject to supply agreements.
• BASF and Evonik Industries: Leading chemical companies with extensive custom synthesis capabilities. Although primarily focused on intermediates and specialty chemicals, they may serve as suppliers for custom API synthesis for proprietary entities.
• Alibaba, ChemShuttle, and other B2B Platforms: Online platforms facilitate connections between buyers and verified manufacturers, especially for research-grade APIs. However, due diligence on quality and regulatory compliance is essential when sourcing from these channels.

3. Asian API Manufacturers

China and India are prominent hubs for API manufacturing due to cost advantages and large chemical industries.

• Zhejiang Huahai Pharmaceutical: Known for CNS APIs, with capabilities for complex chemical synthesis, including H3 receptor agents under development.
• Jiangsu Hengrui Medicine Co., Ltd.: A major Chinese pharmaceutical company with diverse API manufacturing portfolio. While not officially disclosed as producing pitolisant, similar compounds are within their scope.
• Aurisco (Shanghai): Capable of custom synthesis, offering potential API supply options, provided quality and regulatory compliance are validated.

4. European API Suppliers

European manufacturers often focus on high-quality GMP APIs due to stringent regulatory environments.

• Noramco (Belgium): Specializes in CNS APIs and may serve as a potential source for pitolisant hydrochloride, contingent on licensing.
• Lonza: A contract development and manufacturing organization with extensive experience in complex APIs, although specific involvement with pitolisant is unconfirmed.

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Regulatory and Quality Considerations

• GMP Certification: Sourcing from suppliers with validated GMP certification is imperative to ensure batch-to-batch consistency, purity, and compliance with regulatory standards เช่น EMA, FDA.
• Analytical Data and Certificates of Analysis: Customers should require detailed documentation, including HPLC purity, residual solvent levels, and impurity profiles.
• Supplier Audits and Qualification: Negotiate audits and quality audits to verify manufacturing practices, facility standards, and compliance documentation.

Market Dynamics and Supply Chain Challenges

• Patent Status and Market Exclusivity: Patent protections influence manufacturing rights and API supply options. Once patents expire, more manufacturers typically enter the market.
• Production Capacity and Lead Times: Complex APIs like pitolisant may have limited production capacity, leading to supply shortages or longer lead times.
• Geopolitical Factors: Trade policies, export restrictions, and geopolitical tensions can impact sourcing reliability, especially from regions like China and India.

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Emerging Trends in API Sourcing for CNS Agents

• Vertical Integration: Larger pharmaceutical entities may prefer in-house manufacturing to control quality.
• Partnerships and Licensing: Strategic alliances with known API manufacturers can secure supply and ensure quality standards.
• Regulatory Harmonization: Increasing global regulatory harmonization facilitates smoother cross-border API sourcing.

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Conclusion

Sourcing pitolisant hydrochloride API requires navigating a complex landscape of regional manufacturers, regulatory standards, and supply chain logistics. While direct public disclosures about specific API suppliers remain scarce due to confidentiality agreements, established players in CNS API manufacturing, particularly in China, India, and Europe, are potential sources. Quality assurance, GMP compliance, and thorough supplier validation are non-negotiable elements in establishing reliable API procurement.

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Key Takeaways

• Identify reputable GMP-certified manufacturers with CNS API experience for high-quality pitolisant hydrochloride procurement.
• Leverage strategic partnerships with CMOs or API custom synthesis providers to ensure supply reliability.
• Perform due diligence through audits, verification of analytical data, and regulatory compliance documentation.
• Monitor patent and regulatory landscapes to anticipate market entry of new suppliers and competitive pricing.
• Consider regional geopolitical risks and logistical factors impacting supply chain stability.

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FAQs

1. Are there multiple global sources for pitolisant hydrochloride API?
   Yes, multiple regional manufacturers in China, India, and Europe can produce pitolisant hydrochloride, subject to regulatory approval and quality standards.

2. What quality standards should API suppliers meet?
   Suppliers must adhere to GMP standards, providing Certificates of Analysis, impurity profiles, and validation data consistent with FDA or EMA regulations.

3. How can companies verify API supplier credibility?
   Through supplier audits, third-party certifications, reviews of regulatory history, and verification of manufacturing facilities.

4. Is patent expiration influencing API availability?
   Potentially. Patent expirations open the market for generic API manufacturing, increasing available sources and reducing costs.

5. What are the main challenges in sourcing pitolisant API?
   Challenges include limited manufacturing capacity, regulatory compliance verification, geopolitical tensions, and ensuring consistent quality across batches.

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References

[1] European Medicines Agency. Wakix (pitolisant) Summary. EMA, 2022.
[2] U.S. FDA. DRUG APPROVAL PACKAGE: Wakix (pitolisant). FDA, 2019.
[3] PharmaCompass. Global API Market Reports and Supplier Directory. 2021.
[4] Contract Pharma. Trends in CNS API Manufacturing. 2020.
[5] Industry online sourcing platforms: Alibaba, ChemShuttle. Accessed 2023.

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Note: Due to confidentiality in API manufacturing contracts, specific manufacturer names for pitolisant hydrochloride may not be publicly disclosed. Caution should be exercised when sourcing through online platforms; verification of quality and compliance remains essential.