Bulk Pharmaceutical API Sources for COMPAZINE

Bulk Pharmaceutical API Sources for COMPAZINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-001-611-821
AKos Consulting & Solutions		AKOS003600762
Amadis Chemical		A831861

Bulk Active Pharmaceutical Ingredient (API) Sources for COMPAZINE

Last updated: July 30, 2025

Introduction

Compazine, the brand name for chlorpromazine, is a first-generation antipsychotic agent primarily used for schizophrenia, nausea, and severe agitation. As a critical therapeutic agent, the sourcing and manufacturing quality of its Active Pharmaceutical Ingredient (API) directly influence drug efficacy, safety, regulatory compliance, and supply chain stability. This report examines the global landscape of chlorpromazine API sources, exploring key manufacturers, supply trends, regulatory considerations, and future outlooks to inform industry stakeholders and healthcare providers.

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Overview of Chlorpromazine API Manufacturing

Chlorpromazine’s API synthesis involves complex chemical processes that demand rigorous quality control and compliance with Good Manufacturing Practices (GMP). The API’s global manufacturing footprint is concentrated in regions with established pharmaceutical industries, mainly in India, China, and to a lesser extent, Europe and North America.

Manufacturers sourcing for COMPAZINE must evaluate factors such as manufacturing lifecycle stages, regulatory approvals, capacity, and quality certifications. These elements shape supply chain resilience and influence market pricing dynamics.

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Major Producers of Chlorpromazine API

Indian Pharmaceutical Manufacturers

India remains the predominant supplier of chlorpromazine API, driven by its robust API manufacturing infrastructure, cost competitiveness, and comprehensive regulatory frameworks.

• Torrent Pharmaceuticals: A leading global API producer, Torrent has extensive experience in producing antipsychotic APIs, including chlorpromazine. Their facilities adhere to US FDA, EMA, and WHO GMP standards, ensuring high-quality product supply.

• Wockhardt Ltd.: Wockhardt's global API manufacturing units supply chlorpromazine, with certifications from major regulatory agencies. Their strategic focus on sterile and non-sterile APIs positions them as a reliable supplier.

• Aurobindo Pharma: A significant player in the API market, Aurobindo offers chlorpromazine API with consistent quality, supported by established supply chain networks.

• Jubilant Life Sciences: Known for a broad API portfolio, Jubilant's facilities produce chlorpromazine API meeting international regulatory standards.

Chinese API Manufacturers

China serves as a vital source of chlorpromazine API, driven by lower production costs and large-scale manufacturing capacity.

• North China Pharmaceutical Group Corporation (NCPC): A state-owned enterprise, NCPC supplies chlorpromazine API compliant with GMP standards and supplies both domestic and international markets.

• Shandong Xinhua Pharmaceutical: Provides chlorpromazine API conforming to quality standards, catering predominantly to Asian markets but increasingly to global clients.

European and North American Suppliers

While less prominent, some European and North American pharmaceutical API manufacturers produce chlorpromazine under strict regulatory compliance to serve specialized markets.

• BASF: Historically involved in chemical synthesis, BASF supplies pharmaceutical-grade intermediates and APIs, including chlorpromazine, primarily for research and regulated markets.

• Hoffmann-La Roche: Although their focus has shifted, certain legacy APIs are still sourced from Roche’s approved manufacturing sites, compliant with strict cGMP standards.

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Supply Chain Considerations

Given the critical nature of API purity and supply reliability, companies sourcing chlorpromazine should evaluate:

• Regulatory Compliance: Ensuring suppliers possess necessary certifications such as WHO-GMP, US FDA, EMA, or Pharmaceutical Inspection Co-operation Scheme (PIC/S).

• Manufacturing Capacity: To mitigate shortages, sourcing from multiple suppliers or regions can enhance supply resilience.

• Supply Chain Transparency: Reliable documentation, batch traceability, and quality assurance processes are essential for expedited regulatory approval and patient safety.

• Pricing and Contract Terms: Cost competitiveness must be balanced with supplier reliability and quality assurances.

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Regulatory and Quality Landscape

API sourcing is heavily governed by regulatory agencies to ensure safety and efficacy. Manufacturers must maintain GMP compliance and undergo regular audits:

• Regulatory Approvals: Suppliers with approvals from major agencies aid in facilitating faster registration, especially for generic applications or parallel markets.

• Quality Certifications: ISO certifications, pharmacopoeial compliance (e.g., USP, EP, JP), and stability data bolster supplier credibility.

The evolving landscape of API regulations emphasizes the importance of supply chain robustness amidst geopolitical tensions, trade policies, and quality standards tightening, especially in the post-pandemic era.

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Market Trends and Future Outlook

• Increasing Demand: The longstanding use of chlorpromazine in psychiatric and antiemetic indications sustains stable demand, particularly in emerging economies.

• Supply Chain Diversification: To reduce dependency risks, diversified sourcing strategies are gaining momentum, with companies engaging suppliers across multiple regions.

• Technological Advancements: Innovations in chemical synthesis and process optimization could improve yields, reduce costs, and enhance API purity.

• Regulatory Stringency: Enhanced quality standards pose challenges but also opportunities for suppliers to differentiate through superior compliance and product integrity.

• Potential Disruption Factors: Geopolitical tensions, export restrictions, and raw material availability could impact supply stability.

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Conclusion

The procurement landscape for chlorpromazine API involves a diverse array of global suppliers, with Indian and Chinese manufacturers dominating due to cost and capacity advantages. Ensuring supply chain resilience necessitates rigorous vetting of manufacturing quality, regulatory compliance, and operational stability. As therapeutic demands persist, strategic sourcing and continuous monitoring of regulatory developments are essential for pharmaceutical companies manufacturing or marketing COMPAZINE.

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Key Takeaways

• India and China are the primary sources of chlorpromazine API, accounting for most global supply.

• Regulatory compliance such as WHO-GMP and US FDA approvals are critical in selecting reliable API suppliers.

• Supply chain diversification mitigates risks posed by geopolitical and regulatory uncertainties.

• Technology and process innovations will shape future manufacturing efficiency and quality standards.

• Market stability hinges on balancing cost, quality, regulatory adherence, and logistical robustness.

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FAQs

1. What are the primary regions supplying chlorpromazine API for global markets?
India and China dominate the supply chain, leveraging their extensive manufacturing infrastructure and cost advantages. Europe and North America play minor roles, primarily in specialized or high-regulatory-standard markets.

2. How can pharmaceutical companies verify the quality of chlorpromazine API suppliers?
By reviewing GMP certifications, regulatory approvals (FDA, EMA, PIC/S), batch traceability, quality audit reports, and third-party certifications such as ISO standards.

3. What are the main challenges in sourcing chlorpromazine API?
Regulatory compliance, supply chain disruptions, raw material shortages, geopolitical factors, and maintaining consistent product quality.

4. How is the rising regulatory stringency affecting API supply sources?
It incentivizes manufacturers to upgrade quality management systems, leading to increased costs but ensuring higher product safety and facilitating international market access.

5. What future developments could influence chlorpromazine API sourcing?
Adoption of process innovations, diversification of suppliers, increased regulatory oversight, and geopolitical shifts could all impact sourcing strategies and market stability.

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References

1. Pharmaceutical Technology. "Global API Manufacturing Landscape." 2022.
2. WHO. "Good Manufacturing Practices for Active Pharmaceutical Ingredients." 2019.
3. Indian Pharma News. "Indian API Industry Overview." 2022.
4. Chinese API Manufacturers Directory. "Major APIs in China." 2021.
5. Regulatory Affairs Professionals Society (RAPS). "API Regulatory Considerations." 2022.