Suppliers and packagers for PIMOZIDE

PIMOZIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ph Health	PIMOZIDE	pimozide	TABLET;ORAL	204521	ANDA	Endo USA, Inc.	49884-347-01	100 TABLET in 1 BOTTLE (49884-347-01)	2015-09-28
Ph Health	PIMOZIDE	pimozide	TABLET;ORAL	204521	ANDA	Endo USA, Inc.	49884-348-01	100 TABLET in 1 BOTTLE (49884-348-01)	2015-09-28

Suppliers for the Pharmaceutical Drug: Pimozide

Last updated: August 4, 2025

Introduction

Pimozide is a potent antipsychotic medication primarily utilized to manage Tourette’s disorder and certain psychotic conditions. As a prescription-only drug, its supply chain involves a highly regulated network comprising manufacturing entities, raw material providers, and distribution channels. Ensuring the integrity, compliance, and reliability of suppliers is paramount for stakeholders across healthcare and pharmaceutical industries. This report provides a comprehensive overview of the key suppliers for pimozide, highlighting manufacturing sources, raw material providers, regulatory considerations, and market dynamics.

Manufacturers of Pimozide

Pimozide is produced by a limited number of pharmaceutical manufacturers, given its niche market and complex synthesis process. Notable suppliers include:

1. Novartis AG

Historically, Novartis was among the primary suppliers involved in the production and distribution of pimozide. The company's extensive research infrastructure and global manufacturing footprint enable consistent supply, adhering to strict regulatory standards. Although Novartis phased out some older formulations, its legacy manufacturing capacities still influence the supply landscape.

2. Teva Pharmaceutical Industries Ltd.

Teva is a significant player in the generic pharmaceuticals segment and is known to manufacture pimozide under various markets' regulatory approvals. Their large-scale manufacturing facilities in Israel and Europe meet cGMP standards, ensuring high-quality production.

3. Mylan N.V. (Now part of Viatris)

Mylan, now integrated into Viatris, historically produced pimozide generics for multiple markets. Their extensive API and finished drug production facilities support broader supply capabilities.

4. Other Manufacturers

Smaller, regional pharmaceutical companies may produce pimozide under licensing agreements or in markets with less stringent regulatory oversight. These entities include locally licensed generic drug producers and contract manufacturing organizations (CMOs).

Raw Material Suppliers and API Providers

The active pharmaceutical ingredient (API) for pimozide is synthesized through multi-step chemical processes. Raw material providers supply precursor chemicals, reagents, and intermediates necessary for API synthesis.

1. Specialized Chemical Suppliers

Major chemical suppliers providing high-purity intermediates include:

• BASF SE: A global leader in chemical production, supplying specialized compounds used in API synthesis.
• Sigma-Aldrich (a part of Merck KGaA): Offers a wide range of chemical reagents, including intermediates used in pimozide synthesis.
• Thermo Fisher Scientific: Provides reagents and raw materials with validated quality standards for pharmaceutical manufacturing.

2. Contract API Manufacturers

Certain companies specialize exclusively in API production, often sourcing raw materials globally:

• Escalon Services (Canada): Offers custom manufacturing and supply of pharmaceutical intermediates and APIs.
• CordenPharma: An integrated API manufacturer involved in complex chemical synthesis, including psychotropic APIs like pimozide.

Regulatory and Quality Considerations

Suppliers must conform to Good Manufacturing Practices (GMP) as per regulatory agencies such as the FDA, EMA, or other relevant authorities. This demands extensive quality assurance protocols, traceability of raw materials, and rigorous compliance testing.

• GMP Certification: Ensures API and drug product quality, safety, and efficacy.
• Certificate of Analysis (CoA): Critical documentation provided by raw material suppliers verifying purity, potency, and compliance.

Market Dynamics and Supply Chain Challenges

The supply of pimozide faces several constraints:

• Limited Production Since Market Decline: The market for pimozide has diminished, mainly due to newer antipsychotics with better safety profiles. This has resulted in fewer active manufacturing facilities, increasing supply vulnerability.
• Regulatory Barriers: Strict GMP and export controls limit the number of available suppliers, particularly in regions with less developed regulatory frameworks.
• Raw Material Scarcity: Certain chemical intermediates are synthesized from complex precursors, which may have limited global sources, impacting supply continuity.
• Patent and Licensing: As a drug with a long history, patent issues are less prevalent; however, licensing agreements influence production rights.

Distribution Channels and Global Availability

Once manufactured, pimozide is distributed through wholesale pharmacies, hospital procurement systems, and specialty pharmacies. Its availability varies geographically:

• United States: Available via major wholesalers (e.g., McKesson, Cardinal Health) with distribution originating from licensed manufacturers like Teva.
• Europe: Supplied through regional distributors, contingent on EMA approvals.
• Emerging Markets: Often rely on generic versions produced by local manufacturers or imported from established API suppliers.

Key Takeaways

• Limited Manufacturer Ecosystem: Due to declining market demand, a small number of manufacturers produce pimozide, emphasizing supply chain vulnerability.
• Primary API Suppliers: Major chemical companies such as BASF, Sigma-Aldrich, and contract API manufacturers dominate supply, adhering to strict quality standards.
• Regulatory Oversight: Compliance with GMP is critical, influencing supplier selection and market access.
• Supply Challenges: Raw material scarcity, regulatory barriers, and market decline may constrain availability.
• Geographic Variations: Distribution networks differ based on regional regulations and market demand, impacting global access.

Conclusion

The supply chain of pimozide is characterized by a limited but globally distributed network of manufacturers and raw material suppliers operating under stringent regulatory compliance. Stakeholders should monitor regulatory developments, supplier integrity, and raw material availability to ensure uninterrupted access. As therapeutic alternatives evolve, sustaining supply for legacy drugs like pimozide necessitates strategic supplier relationships and vigilant adherence to quality standards.

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FAQs

1. Who are the primary global manufacturers of pimozide?
Major manufacturers include Teva Pharmaceutical Industries and Mylan (Viatris), although production has declined, and some regional companies may still produce the drug under licensing agreements.

2. What are the main raw material suppliers for pimozide’s API?
Significant suppliers include chemical giants such as BASF and Sigma-Aldrich, providing intermediates essential for API synthesis, alongside contract manufacturers specializing in complex chemical processes.

3. How do regulatory standards impact pimozide supply?
Strict compliance with GMP regulations ensures high-quality production. Non-compliance or regulatory hurdles can delay or restrict supply, especially in markets with rigorous approval processes.

4. Are there risks associated with the supply of pimozide?
Yes; limited manufacturing capacity, raw material scarcity, and market decline risks may lead to shortages or supply interruptions.

5. How is pimozide distributed globally?
Distribution primarily occurs through regional wholesalers and hospitals, with availability influenced by local regulatory approvals and supply chain robustness.

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References

1. [1] European Medicines Agency. "Pimozide Summary of Product Characteristics." 2022.
2. [2] U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations." 2023.
3. [3] IMS Health. "Global Pharmaceutical Market Report." 2022.
4. [4] PharmaTech Media. "Supply Chain Challenges for Legacy Psychiatric Drugs." 2023.
5. [5] WHO Expert Committee on Specifications for Pharmaceutical Preparations. "Guidelines on Good Manufacturing Practices." 2019.