Bulk Pharmaceutical API Sources for CHLORPROMAZINE HYDROCHLORIDE INTENSOL

Bulk Pharmaceutical API Sources for CHLORPROMAZINE HYDROCHLORIDE INTENSOL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C0982_SIAL
Sigma-Aldrich		C8138_SIGMA
Molport		MolPort-003-928-768
Hangzhou APIChem Technology		AC-10573
AKos Consulting & Solutions		AKOS005111082
TCI (Tokyo Chemical Industry)		C2481

Bulk Active Pharmaceutical Ingredient (API) Sources for: CHLORPROMAZINE HYDROCHLORIDE INTENSOL

Last updated: August 2, 2025

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Introduction

Chlorpromazine Hydrochloride, marketed under various brand names including INTENSOL, is a first-generation antipsychotic primarily used for schizophrenia, psychosis, and severe behavioral disorders. As a crucial active pharmaceutical ingredient (API) in psychiatric medication, its supply chain integrity, quality assurance, and sourcing are paramount for pharmaceutical manufacturers and healthcare providers.

This comprehensive analysis delineates global bulk API sources for Chlorpromazine Hydrochloride, emphasizing manufacturing regions, supplier reputation, regulatory compliance, and supply chain risk management.

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Global API Manufacturing Landscape for Chlorpromazine Hydrochloride

Historical and Geographical Context

Chlorpromazine Hydrochloride's synthesis experience has demonstrated global manufacturing presence, mainly concentrated in regions with established pharmaceutical chemistry infrastructure such as India, China, Europe, and North America. The API’s complex synthesis process involves multiple chemical steps and high purity standards, necessitating robust manufacturing and quality control.

Key API Producers

• India: The Republic of India is a prominent API producer, boasting several GMP (Good Manufacturing Practice) compliant facilities accredited by international agencies. Companies such as Sun Pharma, Aurobindo Pharma, and Cipla have demonstrated capabilities in manufacturing chlorpromazine intermediates and APIs, often supplying both domestic and export markets.

• China: Chinese API manufacturers are significant players given the competitive manufacturing costs, large-scale chemical syntheses, and extensive export networks. Companies like Zhejiang Hisoar Pharmaceutical and Zhejiang Kangle Pharmaceutical produce Chlorpromazine Hydrochloride, adhering to Chinese GMP standards, with some obtaining EUGMP certification for export.

• Europe and North America: While less dominant in volume, certain specialized European and North American firms manufacture Chlorpromazine Hydrochloride API, typically catering to premium markets with stringent regulatory oversight, including certifications from the EMA or FDA.

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Approved and Certified API Suppliers

Regulatory and Quality Standards

Suppliers are often distinguished by adherence to international standards:

• GMP Certification: Ensures manufacturing processes meet quality benchmarks.
• ISO Certifications: Demonstrates quality management systems.
• US FDA, EMA, and PMDA Approvals: Critical for APIs intended for markets with rigorous regulatory requirements.
• Active Substances Master Files (ASMF) / Certificates of Suitability (CEP): Documentation supporting API compliance with drug approval authorities.

Top API Suppliers for Chlorpromazine Hydrochloride

1. Sun Pharma (India): Recognized for quality production and regulatory compliance, Sun Pharma supplies high-purity Chlorpromazine Hydrochloride, with numerous DMFs filed globally, facilitating approval in multiple jurisdictions.

2. Aurobindo Pharma (India): A leader in pharmaceutical APIs, Aurobindo offers Chlorpromazine Hydrochloride manufactured in GMP-compliant facilities with extensive regulatory documentation.

3. Zhejiang Hisoar Pharmaceutical (China): An established manufacturer with CE and ISO certifications, Hisoar supplies Chlorpromazine API suited for export markets requiring Chinese GMP standards.

4. Shanghai Haling Pharmaceutical (China): Provides API conforming to international standards, supplying both generic and branded pharmaceutical companies.

5. Additional Tier-2 Suppliers: Smaller manufacturers in India and China, with selective certification status, often serve niche markets or provide cost-effective sourcing options.

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Supply Chain Considerations

Quality Assurance & Regulatory Approval

Ensuring API quality is critical. Due diligence involves verifying:

• GMP compliance
• Certification validity
• Batch-to-batch consistency
• Stability and impurity profiles

International regulatory agencies often require rigorous documentation, including DMFs, CEPs, and Certificate of Analysis (COA).

Supply Chain Risks

• Regulatory Delays: Changes in manufacturing standards or regulatory warnings may impact supply.
• Geopolitical Tensions: Trade restrictions and tariffs can affect supplier continuity.
• Capacity Constraints: Sudden surge in demand, especially in pandemic contexts, can strain manufacturing capacity.
• Quality Variability: Variations among suppliers necessitate batch testing and validation.

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Emerging Trends and Future Outlook

• Manufacturing Localization: Increasing trend towards regional API manufacturing to mitigate supply chain disruptions.
• Supply Chain Transparency: Implementation of blockchain and digital tracking for enhanced oversight.
• Sustainability Initiatives: Focus on greener chemical processes aligning with environmental standards.
• Regulatory Convergence: Streamlined international approval pathways to facilitate cross-border sourcing.

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Conclusion

Sourcing Chlorpromazine Hydrochloride API requires meticulous evaluation of manufacturer credibility, regulatory compliance, and supply chain stability. Leading Indian and Chinese manufacturers dominate the bulk API landscape, supported by their established GMP certification and extensive documentation. Buyers must prioritize suppliers with proven quality assurance frameworks, demonstrate regulatory approvals, and sustain agility to adapt to geopolitical and market fluctuations.

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Key Takeaways

• India and China are primary global sources of Chlorpromazine Hydrochloride API, each with established manufacturing infrastructures.
• Ensuring GMP compliance and regulatory approvals (DMF, CEP, registration certificates) is critical for procurement.
• Diversification of supply sources minimizes risks associated with geopolitical, regulatory, or capacity constraints.
• Quality control, including impurity profiling and batch consistency, remains essential for API sourcing.
• Emerging trends focus on regional production, transparency, and sustainable manufacturing practices to secure supply chains.

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FAQs

1. How can I verify the quality and authenticity of Chlorpromazine Hydrochloride API suppliers?
Conduct thorough audits, request GMP certificates, review regulatory filings such as DMFs or CEPs, and perform laboratory quality testing on sample batches before procurement.

2. Are Chinese API manufacturers reliably compliant with international standards?
Many Chinese manufacturers hold ISO, CE, and GMP certifications aligned with international standards. Due diligence and verification of certifications are essential to confirm compliance.

3. What are the risks associated with sourcing from emerging markets?
Risks include variable quality standards, regulatory inconsistencies, supply disruptions, and geopolitical factors. Partnering with reputable, certified suppliers mitigates these risks.

4. How does supply chain disruption impact the availability of Chlorpromazine Hydrochloride?
Disruptions can lead to shortages, delaying production and affecting patient access. Maintaining diversified supplier portfolios and active supply chain monitoring are recommended.

5. What future developments might influence the sourcing landscape for this API?
Regional manufacturing initiatives, digital supply chain tracking, and sustainability efforts are likely to shape reliable sourcing paradigms in the coming years.

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Citations

[1] U.S. FDA Drug Master Files, 2022.
[2] European Medicines Agency (EMA) CEP database, 2023.
[3] Indian pharmaceutical industry reports, 2022.
[4] Chinese GMP certification records, 2023.
[5] Industry analysis reports on pharmaceutical APIs, 2023.