Bulk Pharmaceutical API Sources for TRIFLUOPERAZINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for TRIFLUOPERAZINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T6062_SIAL
Sigma-Aldrich		T8516_SIGMA
Molport		MolPort-000-917-737
Amadis Chemical		A826478

Bulk Active Pharmaceutical Ingredient (API) Sources for: Trifluoperazine Hydrochloride

Last updated: July 29, 2025

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Overview of Trifluoperazine Hydrochloride

Trifluoperazine Hydrochloride is a typical antipsychotic agent belonging to the phenothiazine class. It is primarily used to manage schizophrenia, anxiety, and agitation. Recognized for its efficacy, the API's sourcing is critical for pharmaceutical manufacturers due to stringent quality standards and regulatory compliance. While widely available, sourcing reputable and compliant suppliers ensures drug safety, efficacy, and regulatory adherence.

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Global API Manufacturing Landscape

The API manufacturing industry is globally distributed, with key production hubs in India, China, and Europe. India and China dominate the production of generic APIs, including Trifluoperazine Hydrochloride, due to cost efficiencies and manufacturing expertise. European companies mainly focus on high-value specialty APIs with strict Good Manufacturing Practice (GMP) standards. Understanding this landscape aids in identifying trustworthy sources aligning with regulatory requirements such as the US FDA, EMA, or WHO GMP standards.

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Key Criteria for API Suppliers

1. Regulatory Compliance: Suppliers must adhere to current good manufacturing practices (cGMP) certified by relevant authorities (e.g., FDA, EMA, WHO).
2. Quality Assurance: High purity levels, consistent batch-to-batch quality, validated analytical methods, and rigorous quality control testing.
3. Certifications and Documentation: Certificates of Analysis (CoA), Certificate of Suitability (CEP), Drug Master Files (DMF), and compliance with pharmacopoeia standards (USP, EP, JP).
4. Capacity and Reliability: Ability to supply commercial quantities consistently without compromising quality.
5. Traceability and Transparency: Clear traceability regarding raw materials, manufacturing sites, and quality audits.

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Major Suppliers and Sources

1. Indian API Manufacturers

a. Sun Pharma Advanced Research Company (SPARC)

• Profile: A prominent Indian pharmaceutical company specializing in complex API synthesis and custom manufacturing.
• Capabilities: Offers high-quality APIs compliant with international standards; has a robust GMP-certified facility.
• Reputation: Known for stringent quality control processes and extensive regulatory submissions.
• Supply Focus: Focuses on generic APIs, including phenothiazines like Trifluoperazine Hydrochloride.

b. Dr. Reddy's Laboratories

• Profile: One of India's leading API and generic drug manufacturers.
• API Portfolio: Includes a broad range of neuroleptic and phenothiazine APIs.
• Certifications: GMP-certified facilities with worldwide regulatory approvals.

c. Glenmark Pharmaceuticals

• Profile: Known for cost-competitive manufacturing and high-quality APIs.
• Quality Assurance: Demonstrates compliance with international pharmacopoeia and quality standards.

2. Chinese API Manufacturers

a. Shaanxi Furen Pharmaceutical Co., Ltd.

• Credentials: Certified GMP facilities with export licenses.
• Quality Systems: Emphasizes compliance with US FDA and European standards.
• Product Range: Supplies phenothiazine-related APIs including Trifluoperazine Hydrochloride.

b. Zhejiang Hisoar Pharmaceutical Co., Ltd.

• Capabilities: Focuses on complex synthetic APIs, including neuroleptics.
• Regulatory Standing: Holds multiple certifications and maintains high purity standards.

3. European API Suppliers

a. Recipharm (Sweden) & Wockhardt (UK)

• Focus: Often serve as contract manufacturers and suppliers for high-value APIs.
• Standards: Certified under EMA and adhere to rigorous quality protocols.

b. International API Traders and Distributors

• Large global traders such as Therapeutic Solutions International, Rottapharm, and LGM Pharma source from multiple manufacturers to ensure quality and reliability. They often hold extensive DMFs and regulatory documentation.

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Alternative & Emerging Sources

Given geopolitical dependencies and regulatory considerations, some companies explore regional alternatives or undertake in-house synthesis for critical APIs. Suppliers offering custom synthesis or clinical batch production can be suitable for niche or research purposes, while established commercial suppliers remain preferable for large-scale manufacturing.

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Regulatory & Quality Verification

Prior to procurement, detailed due diligence must be performed:

• Verify GMP certifications.
• Review COA and Pharmacopoeia compliance.
• Evaluate audit reports and regulatory inspections.
• Confirm raw material sourcing and manufacturing processes.

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Emerging Trends in API Sourcing

• Supply Chain Resilience: Ongoing geopolitical tensions and supply chain disruptions prompt diversification of sources.
• Regulatory Harmonization: Suppliers increasingly align with international standards to ease global distribution.
• Sustainability Focus: Growing emphasis on environmentally sustainable manufacturing practices influences supplier selection.

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Conclusion

The procurement of Trifluoperazine Hydrochloride API requires strategic selection from reputable manufacturers committed to quality and compliance. Indian and Chinese API producers dominate the market, with European suppliers providing high-quality options for specialty or regulated markets. Due diligence, regulatory validation, and supply chain robustness remain paramount to ensure consistent, safe, and compliant pharmaceutical production.

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Key Takeaways

• Indian and Chinese manufacturers are primary sources for Trifluoperazine Hydrochloride APIs, offering cost-effective production aligned with international standards.
• Rigorous supplier vetting—including GMP certification, technical documentation, and quality assurance—is essential for regulatory compliance.
• Diversifying supply sources reduces risk and enhances supply chain resilience.
• Emerging trends favor sustainability and global regulatory harmonization among API suppliers.
• Strategic partnerships with established API traders can facilitate access to verified APIs aligned with quality standards.

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FAQs

1. What are the primary considerations when sourcing Trifluoperazine Hydrochloride API?
Ensuring GMP compliance, verifying quality certifications, assessing supplier reliability, and confirming regulatory approval are crucial for trustworthy sourcing.

2. Are Indian and Chinese API manufacturers reliable for pharmaceutical-grade Trifluoperazine Hydrochloride?
Yes, many Indian and Chinese manufacturers have achieved stringent regulatory certifications, including GMP compliance, making them reliable sources when properly vetted.

3. How can companies verify the quality of API suppliers?
Through reviewing Certificates of Analysis, auditing manufacturing facilities, validating supplier certifications (GMP, CEP, DMF), and conducting independent analytical testing.

4. What impact do regulatory agencies have on API sourcing?
Regulatory agencies like the FDA and EMA set standards that suppliers must meet; sourcing from compliant manufacturers helps ensure product acceptance across markets.

5. Are there alternatives to traditional API sourcing methods?
Yes, companies increasingly turn to contract manufacturing organizations (CMOs), custom synthesis providers, and regional suppliers to diversify and secure their supply chain.

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References

[1] U.S. Food and Drug Administration. GMP Regulations. FDA.
[2] European Medicines Agency. Certification standards for APIs. EMA.
[3] Global Sources. API market overview and supplier directory.
[4] Indian Pharmaceutical Alliance. Industry standards for API manufacturing.
[5] China Food and Drug Administration. Regulatory framework for APIs.