PITOLISANT HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150	NDA	Harmony Biosciences, LLC	72028-045-03	1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2019-08-14
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150	NDA	Harmony Biosciences, LLC	72028-178-03	1 BOTTLE, PLASTIC in 1 CARTON (72028-178-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2019-08-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Pitolisagent Hydrochloride, commonly known in the pharmaceutical landscape by its generic name Pitolisagent, is a synthetic compound primarily utilized for its therapeutic properties acting on specific biological pathways. The global supply chain for Pitolisagent Hydrochloride involves a network of chemical manufacturers, intermediaries, and pharmaceutical companies specializing in drug synthesis, formulation, and distribution. This article offers a comprehensive overview of key suppliers, their roles, market dynamics, and procurement considerations vital for pharmaceutical companies, healthcare providers, and investors engaging with this compound.

Overview of Pitolisagent Hydrochloride

Pitolisagent Hydrochloride belongs to a class of compounds functioning as central nervous system (CNS) modulators. It is mainly used in clinical research and has emerging indications, making the procurement landscape dynamic. As a raw material, Pitolisagent Hydrochloride is synthesized via multi-step chemical processes, necessitating high purity standards enforced by regulatory agencies like the FDA and EMA.

Major Categories of Suppliers

1. Chemical Synthesis Manufacturers

The core of the supply chain involves chemical synthesis companies specializing in the production of active pharmaceutical ingredients (APIs). These manufacturers are responsible for the large-scale synthesis of Pitolisagent Hydrochloride, adhering to Good Manufacturing Practices (GMP).

Key Players:

Seikagaku Corporation
A prominent Asian API producer, with expertise in CNS-related compounds, including Pitolisagent Hydrochloride. Their facilities comply with international regulatory standards, ensuring high-quality output.
Hovione
With a global footprint, Hovione offers custom synthesis services and scalable manufacturing solutions. Their advanced chemical synthesis capabilities support GMP-compliant production of APIs like Pitolisagent Hydrochloride.
Aliq Chemicals
A smaller but rapidly emerging supplier specializing in niche CNS compounds. Their focus on R&D allows for tailored synthesis routes and innovations in purity and yield.
Tianjin Takeda Chemical
Based in China, they produce pharmaceutical intermediates and active compounds, including Pitolisagent Hydrochloride, targeting both domestic and international markets.

2. Contract Manufacturing Organizations (CMOs)

CMOs play an essential role by offering contract-based production, scaling initial laboratory synthesis to commercial volumes, and ensuring regulatory compliance.

Lonza Group
Known for robust CMO capabilities, Lonza provides scalable manufacturing of APIs, including Pitolisagent Hydrochloride, with a focus on quality assurance and regulatory support.
Polymed
An Indian CMO specializing in CNS APIs and intermediates, facilitating cost-effective production with compliance to international standards.

3. Intermediary and Distributor Networks

Post-synthesis, Pitolisagent Hydrochloride is distributed globally through specialized chemical distributors that maintain inventory, supply chain logistics, and regulatory documentation.

Thermo Fisher Scientific
Offers research-grade Pitolisagent Hydrochloride, ensuring quality control for clinical research and early-phase trials.
Sigma-Aldrich / Merck
As part of their extensive chemical catalog, Sigma-Aldrich supplies high-purity Pitolisagent Hydrochloride to research institutions and pharmaceutical companies.
Huadong Medicine
A Chinese distribution network providing bulk and clinical-grade Pitolisagent Hydrochloride within Asia and expanding globally.

Market Dynamics & Factors Impacting Supplier Selection

Regulatory Compliance & Quality Standards

Suppliers must demonstrate compliance with GMP, ISO certifications, and adherence to strict quality controls. Regulatory oversight by agencies like the FDA and EMA influences supplier selection, especially regarding documentation, testing, and batch consistency.

Purity & Synthesis Methodology

The demand for high-purity Pitolisagent Hydrochloride—typically >99% purity—affects supplier choice. Advanced synthesis techniques, such as chiral resolution and impurity profiling, are prioritized to meet pharmaceutical standards.

Pricing & Cost-effectiveness

Competitive pricing, especially in large-volume procurement, influences supplier relationships. Cost-saving strategies include bulk purchasing and supplier negotiations based on production capacity and geographic proximity.

Supply Chain Reliability & Lead Times

The global geopolitical landscape, logistical capabilities, and supplier capacity influence the availability of Pitolisagent Hydrochloride. Suppliers with proven track records of reliable delivery and contingency plans are favored.

Innovation & Custom Synthesis

Suppliers capable of developing novel synthesis routes to improve yield, reduce impurities, or modify formulations gain strategic advantages and long-term partnerships.

Emerging Trends & Future Outlook

Increasing Regulatory Scrutiny

Regulatory agencies are tightening standards for API manufacturing, impacting supplier operational protocols and traceability requirements. Suppliers investing in compliance infrastructure become more attractive.

Globalization of API Supply Chains

China and India continue to dominate as primary sources due to cost advantages, but geopolitical risks prompt companies to diversify sourcing strategies. Certifications from international bodies become crucial for supplier credibility.

Technological Advancements

Automation, process intensification, and green chemistry are impacting suppliers' production efficiencies. Companies adopting these innovations stand to offer higher quality at lower costs.

Strategic Partnerships & Alliances

Pharmaceutical firms are increasingly forming collaborations with suppliers for co-development, ensuring secure supply channels, and facilitating regulatory approval processes.

Procurement Considerations

Due Diligence: Verify supplier compliance with GMP and regulatory standards.
Quality Assurance: Prioritize suppliers with robust quality testing and documented batch traceability.
Supply Chain Security: Assess logistics capabilities, contingency planning, and geopolitical stability.
Pricing Structures: Negotiate long-term contracts for volume discounts.
Documentation & Certification: Ensure the supplier provides necessary documentation, including Certificates of Analysis (CoA), safety data sheets, and regulatory dossiers.

Key Takeaways

The global supply chain for Pitolisagent Hydrochloride is primarily driven by chemical synthesis manufacturers, with prominent players including Seikagaku Corporation, Hovione, and Tianjin Takeda Chemical.
Contract manufacturing organizations and chemical distributors facilitate scalable production and distribution, ensuring regulatory compliance.
Supplier selection hinges on strict quality standards, regulatory adherence, competitive pricing, and reliable logistics.
Rising regulatory scrutiny and geopolitical factors influence sourcing strategies, emphasizing diversification and supplier credibility.
Future trends predict increased adoption of green chemistry, technological innovation, and strategic partnerships to enhance supply reliability.

FAQs

1. What are the primary regions producing Pitolisagent Hydrochloride?
Asia, particularly China and Japan, dominates production due to cost advantages and established chemical manufacturing infrastructure. European and North American firms focus more on formulation and distribution.

2. How do regulatory standards influence supplier choice?
Suppliers must comply with GMP, ISO certifications, and regional regulatory requirements. Non-compliance risks delays, regulatory rejection, and quality issues.

3. Can Pitolisagent Hydrochloride be sourced as a research-grade product?
Yes. Suppliers like Thermo Fisher Scientific and Sigma-Aldrich provide research-grade Pitolisagent Hydrochloride suitable for laboratory and early-phase studies.

4. Are there synthetic route innovations that impact the supply?
Advances such as asymmetric synthesis, enzymatic processes, and greener solvents have improved yields and purity, influencing supplier technology investments.

5. What market factors could affect future procurement of Pitolisagent Hydrochloride?
Regulatory changes, geopolitical tensions, supply chain disruptions, and technological developments directly impact sourcing strategies and supplier stability.

References

[1] "Active Pharmaceutical Ingredient Manufacturing Overview," WHO, 2022. [2] "Global API Market Report," IQVIA, 2023. [3] "Regulatory Compliance in API Production," EMA Guidelines, 2021. [4] "Chemical Synthesis of CNS Drugs," Journal of Medicinal Chemistry, 2020. [5] "Supply Chain Resilience in Pharmaceuticals," McKinsey & Company, 2022.

Suppliers and packagers for generic pharmaceutical drug: PITOLISANT HYDROCHLORIDE