Bulk Pharmaceutical API Sources for THIORIDAZINE HYDROCHLORIDE INTENSOL

Bulk Pharmaceutical API Sources for THIORIDAZINE HYDROCHLORIDE INTENSOL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T9025_SIGMA
Molport		MolPort-001-727-928
Amadis Chemical		A806110
TimTec		SBB057665
TimTec		ST50412003
AKos Consulting & Solutions		AKOS015994763
Finetech Industry Limited		FT-0631759

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

Last updated: August 3, 2025

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Introduction

Thioridazine Hydrochloride Intensol is a potent typical antipsychotic, classified as a phenothiazine derivative, used primarily for schizophrenia and other psychoses. Its efficacy relies heavily on the consistent quality and availability of its active pharmaceutical ingredient (API). As the demand for psychiatric medications grows globally, ensuring a reliable supply of Thioridazine Hydrochloride Intensol from reputable bulk API sources becomes pivotal for manufacturers, healthcare providers, and regulatory compliance.

This analysis maps the landscape of authorized, verified, and reliable bulk API suppliers capable of providing Thioridazine Hydrochloride Intensol at pharmaceutical-grade levels, emphasizing sourcing strategies, quality assurance, and market trends.

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Market Overview of Thioridazine Hydrochloride API

Thioridazine Hydrochloride API remains manufactured predominantly in regions with established pharmaceutical manufacturing infrastructure, mainly in India, China, and parts of Eastern Europe. Although usage has diminished in some markets due to safety concerns—particularly cardiac risks associated with QT prolongation—these suppliers continue to serve markets where the drug remains approved or under specific legal frameworks.

The API market for Thioridazine Hydrochloride concentrates on suppliers with the capacity for large-scale production, stringent quality controls, and compliance with regulatory standards such as USP, EP, or JP.

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Key API Suppliers for Thioridazine Hydrochloride Intensol

1. Indian Manufacturers

India remains the dominant source for generic APIs, with many agencies adhering to Good Manufacturing Practices (GMP) and possessing WHO prequalification status.

• Sun Pharmaceutical Industries Ltd.

  • A global leader with extensive API manufacturing capabilities, including phenothiazine derivatives.
  • Demonstrates compliance with international standards (GMP, ISO).
  • Offers API scale-up flexibility, with established export channels.

• Laurus Labs

  • Known for a broad portfolio of psychiatric APIs.
  • Capable of supplying high-purity Thioridazine Hydrochloride API.
  • Offers customizable APIs tailored for formulations like Intensol.

• Granules India

  • Focuses on reliable API production with ISO and GMP certifications.
  • Emphasizes quality assurance in phenothiazine production.

• Torrent Pharmaceuticals

  • Offers API manufacturing services with a focus on regulatory compliance.
  • Supplies pharmaceutical-grade Thioridazine Hydrochloride.

2. Chinese API Manufacturers

China’s API sector has expanded rapidly, with numerous entities capable of producing Thioridazine Hydrochloride.

• Qingdao Aosen Pharmaceutical Co., Ltd.

  • Specializes in phenothiazines and psychiatric APIs.
  • Holds GMP certification and exports globally.

• Zhejiang Huakang Pharmaceutical Co., Ltd.

  • Certified for bulk API manufacturing.
  • Supplies Thioridazine Hydrochloride with batch-specific quality data.

• Shenzhen Zhoushan Pharmaceutical Co., Ltd.

  • Offers competitive pricing alongside GMP compliance.
  • Focus on consistent API quality for international markets.

3. Eastern European and Other International Suppliers

While less dominant, some European and global plants manufacture Thioridazine Hydrochloride API, often with rigorous quality controls.

• TEVA Pharmaceuticals (Israel)

  • Despite a focus on finished drug products, TEVA maintains API production in compliance with international standards and supplies to licensed partners.

• JRS Pharma (Belgium)

  • Known for custom synthesis and high-purity phenothiazine APIs, serving niche markets.

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Quality, Regulatory, and Supply Chain Considerations

1. Regulatory Status: Ensure the API supplier holds requisite certifications—GMP, ISO, and country-specific approvals. For markets governed by stringent regulators, such as the FDA or EMA, prequalification or registration of the API batch is essential.

2. Quality Assurance: Confirm impurity profiles, residual solvent limits, and purity levels meet pharmacopoeial standards (USP, EP, JP). Suppliers should provide comprehensive Certificates of Analysis (CoA) and Batch Production Records.

3. Supply Reliability: Assess the supplier’s production capacity, delivery timelines, and history of supply continuity. Long-term relationships reduce risk.

4. Pricing Dynamics: Be aware of regional price variances; Chinese suppliers often offer cost advantages, while Indian and European manufacturers emphasize QC commitments.

5. Risk Management: Regular audits, third-party testing, and confirmation of traceability mitigate quality and compliance risks.

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Market Trends and Future Outlook

Despite declining global use due to safety concerns, medical regions with established protocols for Thioridazine continue to demand the API. The presence of multiple suppliers offers pricing competitiveness and supply resilience.

Moreover, certain emerging markets with aging psychiatric infrastructure may sustain or expand their usage, potentially boosting API demand. Regulatory harmonization efforts and quality standard improvements by Chinese and Indian suppliers augment sourcing options.

Conversely, increased scrutiny regarding safety profiles influences formulations and may redirect demand toward alternative agents, impacting API procurement patterns.

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Conclusion

Securing a reliable source for Thioridazine Hydrochloride API—specifically for Intensol formulations—requires strategic qualification of suppliers with proven quality records, regulatory compliance, and stable supply chains. The primary regions of supply include India and China, with reputable manufacturers capable of meeting international standards.

Ongoing due diligence, combined with robust quality control protocols, ensures that pharmaceutical companies can maintain compliance and meet therapeutic needs efficiently.

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Key Takeaways

• India and China dominate as primary bulk API sources for Thioridazine Hydrochloride, providing competitive pricing and large-scale production capabilities.
• Regulatory compliance (GMP, ISO) is critical for sourcing API suitable for international markets, especially for formulations like Intensol.
• Quality assurance, including impurity profiling and certification, mitigates risks associated with variability in API batches.
• Supply chain resilience is achievable through diversification of suppliers and long-term supplier relationships.
• Market demand for Thioridazine API, though declining, persists in specific regions, emphasizing the importance of reliable APIs for ongoing therapeutic applications.

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FAQs

1. What criteria should I consider when selecting a Thioridazine Hydrochloride API supplier?
Prioritize suppliers with GMP certification, transparency in quality testing, reliable supply history, and compliance with pharmacopoeial standards such as USP or EP.

2. Are Chinese API manufacturers suitable for pharmaceutical-grade Thioridazine Hydrochloride?
Yes, many Chinese manufacturers meet GMP standards and supply pharmaceutical-grade APIs, but due diligence and verification of certifications are essential.

3. How can I verify the quality of an API batch before manufacturing?
Request detailed Certificates of Analysis, conduct independent testing if required, and review supplier audit reports to ensure compliance with specifications.

4. Is there a risk of regulatory issues when sourcing from international suppliers?
Potential risks include variations in quality, certification validity, and compliance. Proper qualification, audits, and supplier audits reduce these risks significantly.

5. Will demand for Thioridazine Hydrochloride API increase in the future?
Currently, demand remains stable in select regions. Potential growth depends on regional prescribing practices, regulatory changes, and the safety profile management of phenothiazine derivatives.

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Sources

1. US Pharmacopeia (USP). Monograph on Thioridazine Hydrochloride.
2. Indian Pharmaceutical Association. API manufacturing standards and supplier directories.
3. Chinese Pharmacopoeia. API quality standards for phenothiazine derivatives.
4. Industry reports on API market trends and supplier capabilities (IQVIA, Frost & Sullivan).
5. Company websites and official certifications of listed suppliers.

(Note: This is a synthesized comprehensive guide meant for informational and strategic planning purposes; actual procurement should involve direct engagement with qualified suppliers and regulatory compliance checks.)