Bulk Pharmaceutical API Sources for chlorpromazine

Bulk Pharmaceutical API Sources for chlorpromazine

Vendor	Vendor Homepage	Vendor Sku	API Url
ASINEX		BAS 00010434
NovoSeek		2726
Vitas-M Laboratory		STK182870
MolPort		MolPort-001-727-953
ISpharm		I14-6226
ABI Chem		AC1L1EBT

Bulk Active Pharmaceutical Ingredient (API) Sources for: CHLORPROMAZINE

Last updated: July 27, 2025

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Introduction

Chlorpromazine, a phenothiazine derivative, remains a pivotal antipsychotic medication primarily used to treat schizophrenia, manic-depressive illness, and intractable hiccups. Despite the emergence of newer agents, chlorpromazine’s API continues to be in demand particularly in regions where cost-effective psychiatric treatment is prioritized. Securing reliable bulk API sources is essential for pharmaceutical manufacturers aiming to meet global demands, ensure quality, and comply with regulatory standards.

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Global API Manufacturing Landscape for Chlorpromazine

The API manufacturing landscape for chlorpromazine is characterized by a concentration of suppliers predominantly deriving from Asia, especially China and India. These regions host several manufacturers capable of large-scale API production, leveraging established chemical synthesis routes and advanced manufacturing facilities. Additionally, a number of European and North American companies offer sourcing options, albeit often at higher cost and with more stringent regulatory oversight.

Key API Production Regions

• China: The dominant supplier globally, with numerous API producers offering chlorpromazine. Chinese manufacturers benefit from established capacities, cost advantages, and compliance with international standards such as GMP (Good Manufacturing Practice).

• India: Emerging as a significant API hub, Indian producers offer competitive pricing and have invested in high-quality manufacturing facilities compatible with international standards.

• Europe and North America: Limited number of suppliers specializing in complex API manufacturing, often catering to niche markets or custom synthesis demands. These suppliers typically command premium prices owing to stringent regulatory compliance and rigorous quality controls.

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Major API Suppliers for Chlorpromazine

Supplier Region	Notable Manufacturers	Certification & Standards	Additional Notes
China	Zhejiang Hisoar Pharmaceutical Co., Ltd., Chongqing Chemoes Pharmaceutical Co., Ltd., Zhejiang Hisun Chemical Co., Ltd.	GMP, ISO 9001/ISO 14001	Capabilities for bulk supply, flexible MOQ, competitive pricing
India	Imperial Chem Pharms, Neuland Laboratories, Aarti Drugs Ltd.	GMP, WHO-GMP, OHSAS	Strong regulatory compliance, reliable delivery
Europe/North America	Sigma-Aldrich (Merck), Teva Pharmaceuticals	cGMP, EUGMP	Niche suppliers with higher cost structure

Note: This list is indicative and does not encompass all suppliers.

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Quality and Regulatory Considerations

Ensuring API quality is critical. Suppliers must demonstrate compliance through GMP certifications, and API batches require extensive analytical testing—such as HPLC purity, residual solvents, heavy metals, and microbiological assessments—to meet pharmacopeial standards (USP, EP, JP). Regulatory agencies scrutinize API quality, especially for APIs originating from regions with variable manufacturing oversight.

Pharmaceutical companies should prioritize suppliers with validated manufacturing processes, comprehensive analytical data, and transparent quality assurance protocols. For export to regulated markets, suppliers often provide COA (Certificates of Analysis), DMFs (Drug Master Files), and batch-specific documentation.

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Supply Chain Dynamics and Risks

Reliance on a limited number of API suppliers introduces supply chain vulnerabilities, including geopolitical risks, manufacturing disruptions, and quality issues. The ongoing COVID-19 pandemic underscored vulnerabilities in supply chains, pushing manufacturers toward diversification strategies.

Mixed sourcing—blending suppliers from different regions—can mitigate risk. Additionally, establishing strategic partnerships and conducting periodic due diligence helps secure consistent and regulatory-compliant supply lines.

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Emerging Trends and Innovations

• API Synthesis Enhancements: Advances in synthetic routes focus on increasing yield, reducing environmental impact, and minimizing residual impurities.
• Regulatory Harmonization: Increased global harmonization of GMP standards eases compliance, broadening supplier markets.
• Vertical Integration: Some pharmaceutical firms have invested in backward integration for API manufacturing, reducing reliance on third parties and increasing supply security.
• Sustainability: Sustainability initiatives, including greener solvents and waste reduction, influence supplier selection and procurement strategies.

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Conclusion

Sourcing bulk chlorpromazine API requires careful evaluation of supplier credentials, quality standards, and supply stability. Asia, especially China and India, dominate the manufacturing landscape, offering cost-effective and high-volume options that meet international regulatory standards. Companies pursuing chlorpromazine API sourcing must prioritize quality assurance, mitigate supply chain risks, and keep abreast of regulatory changes to ensure uninterrupted, compliant supply chains.

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Key Takeaways

• Regional Concentration: Chinese and Indian manufacturers dominate chlorpromazine API supply due to scale and cost advantages.
• Quality Assurance: Suppliers should possess GMP certification, transparent documentation, and demonstrate consistent analytical quality.
• Supply Chain Management: Diversify supplier base to mitigate risks associated with geopolitical, logistical, or quality issues.
• Regulatory Compliance: Ensure sourcing from facilities compliant with international standards (USP, EP, JP, ICH-GMP).
• Innovation & Sustainability: Leverage suppliers adopting greener syntheses and advanced manufacturing techniques.

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FAQs

1. What are the primary regions supplying chlorpromazine API globally?
Chinese and Indian manufacturers supply the majority of chlorpromazine API, with European and North American suppliers offering limited, often high-cost options.

2. How can I ensure API quality when sourcing from Asian manufacturers?
Verify GMP certification, review analytical testing reports (COA), conduct audits if feasible, and request documentation such as DMFs to confirm quality standards.

3. Are there reputable international suppliers for chlorpromazine API?
Yes. Companies like Sigma-Aldrich (Merck) and Teva Pharmaceuticals provide high-quality APIs, often with established regulatory compliance and supply reliability.

4. What are the common regulatory requirements for importing chlorpromazine API?
Compliance with GMP standards, proper documentation (COA, DMF), and adherence to local regulatory agencies’ guidelines (FDA, EMA, etc.) are essential.

5. What supply risks should manufacturers consider when sourcing chlorpromazine API?
Dependence on a limited number of suppliers, geopolitical factors, transportation disruptions, and inconsistency in quality can pose risks; diversification and quality audits mitigate these issues.

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References

1. U.S. Pharmacopeia (USP). Pharmacopoeial standards for chlorpromazine.
2. European Pharmacopoeia (EP). Monograph on chlorpromazine.
3. Chinese National Standards for API manufacturing practices.
4. Indian Pharmacopoeia Commission. Standards for chlorpromazine API.
5. Industry reports on API manufacturing and supply chain analytics.