Bulk Pharmaceutical API Sources for HALDOL SOLUTAB

Bulk Pharmaceutical API Sources for HALDOL SOLUTAB

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		H1512_SIGMA
Calbiochem		371980
HDH Pharma		IN1474
NovoSeek		3559
MP Biomedicals		153696
TCI (Tokyo Chemical Industry)		H0912

Bulk Active Pharmaceutical Ingredient (API) Sources for: HALDOL SOLUTAB

Last updated: August 1, 2025

Introduction
Haldol Solutab, known generically as haloperidol, is a potent antipsychotic medication chiefly indicated for schizophrenia, acute psychosis, and Tourette’s syndrome. As a formulation of haloperidol in a soluble tablet, manufacturing quality and supply chain integrity are crucial. Central to ensuring drug quality, efficacy, and regulatory compliance is sourcing high-quality bulk active pharmaceutical ingredients (APIs). This article explores the global landscape of bulk API sources for haloperidol, emphasizing supply security, quality standards, and regulatory dynamics.

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Understanding Haloperidol API Fundamentals
Haloperidol (chemical name: 4-phenyl-4-(p-chlorophenyl)-4-hydroxy-piperidine-1-ethanone) is synthesized through multi-step chemical processes involving complex intermediates. The raw materials, synthesis route, and manufacturing controls significantly influence API quality. Regulatory agencies such as the FDA, EMA, and PMDA require suppliers to adhere to Good Manufacturing Practices (GMP), ensuring batch-to-batch consistency and contaminant control.

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Global API Manufacturing Landscape for Haloperidol

Major API Producing Countries

India
India remains a dominant player in API manufacturing, including haloperidol, largely due to its comprehensive manufacturing infrastructure, cost advantages, and established regulatory frameworks. Companies like Sun Pharma, Aurobindo Pharma, and Dr. Reddy's Laboratories have capabilities to produce GMP-compliant haloperidol APIs [1]. These firms often serve both domestic and international markets, including North America and Europe.

China
China’s API sector has expanded rapidly, driven by low production costs and specialized chemical synthesis capabilities. Several Chinese firms possess GMP certifications and export haloperidol API globally. Quality assurance, however, remains a focal point for buyers contemplating Chinese sources; rigorous vendor qualification is essential to ensure compliance with international standards.

European Union
Europe hosts a limited number of API manufacturers with high regulatory credibility. Companies such as Solara Active Pharma Sciences (India-based but with EU-approved manufacturing sites) and some smaller European firms supply haloperidol API, emphasizing stringent quality controls and batch transparency [2].

United States
The U.S. has limited domestic API production for haloperidol. Most supply is imported, primarily from India and China. There exist a few specialty API manufacturers with EU-GMP accreditation that export to U.S. pharmaceutical companies under strict regulatory scrutiny.

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Leading API Suppliers and Manufacturers

1. Sun Pharma
   One of the largest Indian API producers, Sun Pharma offers GMP-compliant haloperidol API with established export credentials [3].

2. Aurobindo Pharma
   Known for its diversified portfolio, Aurobindo produces haloperidol API conforming to international regulatory standards, serving global markets.

3. Dr. Reddy’s Laboratories
   Offers high-quality APIs, including haloperidol, with certifications suitable for stringent markets.

4. Harrison and Crossfield
   A UK-based custom synthesis and API manufacturer with a focus on specialized psychotropic APIs, including haloperidol for specific markets.

5. Chinese Suppliers
   Several regional manufacturers such as Zhejiang Huahai Pharmaceutical and Shanghai First Pharmaceutical Co. manufacture haloperidol APIs, often at a lower cost, with varying levels of regulatory audit readiness.

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Regulatory and Quality Considerations

While many manufacturers claim GMP compliance, due diligence remains essential. Suppliers must provide batch documentation, stability data, impurity profiles, and Certificates of Analysis (CoA). Suppliers with ISO certifications, and those audited by major regulatory agencies, are preferred to mitigate supply chain risks and ensure regulatory acceptance across multiple jurisdictions.

The complexity of haloperidol synthesis also mandates rigorous control of residual solvents, heavy metals, and related impurities to meet pharmacopeial standards such as USP, EP, or JP.

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Supply Chain Dynamics and Market Trends

The global API market faces volatility driven by geopolitical tensions, regulatory crackdowns, and COVID-19 disruptions. The reliance on Indian and Chinese suppliers exposes manufacturers to supply chain risks, necessitating diversification strategies. In response, some pharmaceutical corporations are expanding in-house API manufacturing or establishing alliances with reliable suppliers across multiple regions.

The trend toward API API batch traceability and real-time quality monitoring enhances supply chain resilience. Additionally, regulatory agencies continue to tighten import controls, emphasizing the importance of supplier audits and certification validation.

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Key Factors in Selecting Haloperidol API Suppliers

• Regulatory Compliance: GMP certifications, recent audits, and compliance with international standards.
• Quality Control: Consistency, impurity profiles, and stability data.
• Capacity & Lead Time: Ability to meet demand fluctuations and deliver on time.
• Cost: Balanced against quality, regulatory track record, and supply reliability.
• Logistics & Customs: Import-export policies, tariffs, and logistical infrastructure.

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Conclusion

The sourcing of haloperidol API remains concentrated predominantly in India and China, with reliable suppliers also present in Europe and other regions. Businesses seeking secure supply chains should prioritize suppliers with demonstrated GMP compliance, transparent quality documentation, and validated regulatory track records. Given the critical role of API quality in therapeutic efficacy and regulatory approval, comprehensive due diligence is essential.

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Key Takeaways

• India and China dominate the global API market for haloperidol, offering cost-effective and GMP-certified options.
• Rigorous supplier qualification, including audits and certification verification, reduces regulatory and supply chain risks.
• Diversification of API sources mitigates geopolitical and logistical disruptions.
• Quality assurance, including impurity profiling and batch consistency, remains paramount.
• The evolving regulatory landscape necessitates ongoing supplier assessments and compliance monitoring.

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Frequently Asked Questions (FAQs)

1. What are the main countries producing high-quality haloperidol API?
India, China, and select European countries like the UK provide high-quality, GMP-compliant haloperidol APIs, with India and China leading in global production volume.

2. How can I verify the compliance of a haloperidol API supplier?
Verify GMP certificates, recent audit reports, Certificates of Analysis, and regulatory approvals. Working with third-party auditors or consulting agencies can aid supplier qualification.

3. Are Chinese API sources reliable for pharmaceutical manufacturing?
Many Chinese manufacturers produce GMP-compliant APIs; however, variability exists. Due diligence, including on-site audits and quality audits, is crucial before procurement.

4. What certifications should I look for in a haloperidol API supplier?
ISO 9001, GMP certification by recognized agencies (FDA, EMA), and compliance with pharmacopeial standards (USP, EP, JP) are essential indicators of quality.

5. How do supply chain disruptions impact API sourcing?
Disruptions from geopolitical tensions, pandemics, or logistical issues can impair API availability, emphasizing the importance of diversified suppliers and strategic stockpiling.

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References
[1] Indian Pharmaceutical Alliance. "API Production and Export Data." 2022.
[2] European Medicines Agency. "API Manufacturing Standards." 2023.
[3] Sun Pharma Annual Report. "API Portfolio and Quality Assurance." 2022.