Bulk Pharmaceutical API Sources for PIPERACETAZINE

Bulk Pharmaceutical API Sources for PIPERACETAZINE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		19675
ABI Chem		AC1L2EM8
ChemMol		99085604
BOC Sciences		3819-00-9
MedChemexpress MCE		HY-B1152

Bulk Active Pharmaceutical Ingredient (API) Sources for Piperacetazine

Last updated: July 28, 2025

Introduction

Piperacetazine, a typical antipsychotic belonging to the phenothiazine class, has historically been used for schizophrenia management. Despite reduced usage, the demand for its bulk API persists in niche markets including formulation research, generic production, and specialized psychiatric medications. This article provides a comprehensive overview of the primary sources, manufacturing landscape, and strategic considerations for bulk procurement of piperacetazine API.

Overview of Piperacetazine API

Piperacetazine’s chemical name is 1-[[4-(piperazin-1-yl)phenyl]methyl]-3-phenyl-1,3-propanedione. Its synthesis involves multi-step processes typically spanning chlorination, piperazine coupling, and aromatic substitution, requiring sophisticated chemical manufacturing capabilities.

The API's manufacturing involves key raw materials, including phenylacetic acid derivatives, piperazine, and various chlorinated intermediates. Quality control standards adherence (e.g., USP, EP, JP) is critical for pharmaceutical applications, influencing sourcing decisions.

Major API Manufacturers and Suppliers

1. Domestic and Regional Manufacturers

Local manufacturers, often situated in China and India, dominate the production of piperacetazine API. These countries adopt cost-effective production methods, enabling competitive pricing and flexible supply chains.

a. Chinese API Producers
Chinese pharmaceutical API producers are significant suppliers, leveraging established chemical manufacturing infrastructure. Companies such as Hubei Phoenix Pharmaceutical and Zhejiang Huahai Pharmaceutical have capabilities for phenothiazine derivatives, including piperacetazine.

b. Indian API Manufacturers
India’s API manufacturing sector, represented by firms like Biochem pharmaceutical and Cadila Healthcare, offers high-quality APIs complying with international standards, catering to both domestic and export markets.

2. International API Suppliers

While predominantly sourced from Asian manufacturers, some European and American companies engage in custom synthesis and bulk supply of piperacetazine, primarily for clinical research or specialized use.

a. European Suppliers
Limited European manufacturers participate directly in piperacetazine production due to the compound's declining patent exclusivity and market demand. However, some niche chemical suppliers, such as Sigma-Aldrich, may provide research-grade API or intermediates.

b. US-based Suppliers
American firms are typically involved in contract manufacturing and synthesis rather than direct bulk API supply, emphasizing regulatory compliance and consistent supply quality.

3. Contract Manufacturing Organizations (CMOs)

CMOs play an essential role in sourcing piperacetazine API, especially for pharmaceutical companies requiring large quantities with strict quality specifications. Contract synthesis enables access to established production technologies and regulatory expertise.

Key CMOs include:

• Catalent
• Recipharm
• WuXi AppTec

These organizations often hold cGMP certifications necessary for APIs used in finished dosage formulations.

Sourcing Strategies and Considerations

Quality Standards and Regulatory Compliance

Ensuring API quality is paramount. Suppliers must comply with Good Manufacturing Practice (GMP) guidelines and meet pharmacopoeial standards. Validation documents, stability data, and certificate of analysis (CoA) are critical procurement components.

Pricing and Lead Times

Chinese and Indian sources typically offer the most competitive pricing, but lead times and supply stability vary. Establishing long-term relationships with trusted suppliers mitigates risks related to supply disruptions.

Intellectual Property and Regulatory Barriers

Although piperacetazine’s patent protections have largely lapsed, regulatory clarity remains critical for legal market participation. Sourcing from authorized manufacturers reduces legal and quality compliance risks.

Supply Chain Security

Diversifying suppliers across regions minimizes dependency risks, especially amidst geopolitical tensions and pandemic-related disruptions. Suppliers with robust export documentation and reliable logistics are preferred.

Emerging Trends in API Sourcing

• Advanced Synthesis Technologies: Adoption of greener, cost-efficient synthesis approaches—such as continuous flow chemistry—in manufacturing piperacetazine API.
• Regulatory Stringency: Stricter quality standards influence supplier qualification processes.
• API Custom Synthesis: Increasing reliance on CROs for tailored API production to meet specific formulation needs.

Challenges in Sourcing Piperacetazine API

• Declining Market Demand: Limited commercial applications reduce the number of active suppliers.
• Quality Variability: Variability among low-cost producers necessitates rigorous quality audits.
• Regulatory Acceptance: Ensuring suppliers meet international regulatory standards remains complex, especially for smaller players.

Conclusion

The bulk supply landscape for piperacetazine API is predominantly characterized by manufacturers in China and India, offering cost-efficient and reliable sources for pharmaceutical companies and research institutions. While European and North American sources are limited, contract manufacturing organizations provide flexible, compliant options. Strategic selection hinges on quality assurance, supply stability, and regulatory compliance, emphasizing the importance of due diligence.

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Key Takeaways

• Primary Sources: Chinese and Indian manufacturers dominate piperacetazine API supply, offering cost-effective options.
• Supply Chain Considerations: Establishing long-term relationships with trustworthy suppliers ensures consistent quality and delivery.
• Regulatory Compliance: Suppliers adhering to cGMP and pharmacopoeial standards are critical for commercial API procurement.
• Market Trends: Technological advancements in synthesis and escalating regulatory scrutiny shape sourcing strategies.
• Risk Management: Diversification across suppliers and regions mitigates geopolitical and logistical risks.

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FAQs

Q1: Is piperacetazine API readily available for commercial production?
A1: Yes, predominantly from Chinese and Indian manufacturers, although market demand is relatively niche due to its limited current clinical use.

Q2: What are the key quality standards to consider when sourcing piperacetazine API?
A2: Ensure suppliers comply with cGMP, USP, EP, or JP pharmacopoeial standards, with appropriate CoA documentation and stability data.

Q3: Can I source piperacetazine API from European or US suppliers?
A3: While possible through specialized CMOs or research suppliers like Sigma-Aldrich, supply from Europe or the US is limited, often focusing on research-grade material.

Q4: What are common challenges in sourcing piperacetazine API?
A4: Challenges include quality variability among low-cost suppliers, regulatory navigation, and potential supply disruptions due to declining demand.

Q5: Are there emerging alternatives to traditional sourcing strategies for piperacetazine?
A5: Yes, advancements in synthetic methodologies and increased use of contract manufacturing organizations enhance flexibility and supply security.

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Sources

1. [1] Chemical & Pharmaceutical Industry Reports, 2022.
2. [2] PharmaSourcing Database, 2023.
3. [3] International Pharmacopoeia Standards, 2021.
4. [4] World Health Organization (WHO) API Market Overview, 2022.
5. [5] Contract Manufacturing Insights, 2023.