Bulk Pharmaceutical API Sources for PROLIXIN

Bulk Pharmaceutical API Sources for PROLIXIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F4765_SIGMA
Vitas-M Laboratory		STK050763
Molport		MolPort-000-917-736
Molport		MolPort-001-727-938
Hangzhou APIChem Technology		AC-12201
AKos Consulting & Solutions		AKOS001659031

Bulk Active Pharmaceutical Ingredient (API) Sources for PROLIXIN

Last updated: July 27, 2025

Introduction

Prolixin, the brand name for fluphenazine, is a potent antipsychotic medication primarily prescribed for schizophrenia and related psychotic disorders. As with all pharmaceuticals, the procurement and sourcing of the active pharmaceutical ingredient (API) are crucial components ensuring product quality, supply stability, and regulatory compliance.

The API landscape for prochlorperazine and fluphenazine has evolved significantly, with a focus on quality assurance, cost-effectiveness, and geopolitical considerations. This report offers a comprehensive overview of current bulk API sources for PROLIXIN (fluphenazine), analyzing key manufacturers, geographic distribution, regulatory status, and market trends.

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Global API Manufacturing Landscape for Fluphenazine

Major API Producing Countries and Companies

The primary sources of fluphenazine API have traditionally been rooted in Asia, particularly India and China, owing to their large-scale pharmaceutical manufacturing capacities. Several established pharmaceutical companies and contract manufacturing organizations (CMOs) serve as key suppliers.

India

India remains the dominant API producer for fluphenazine, with companies such as:

• Macleods Pharmaceuticals: An established manufacturer with WHO-GMP certification. Macleods supplies APIs globally and maintains stringent quality controls.

• Divi's Laboratories: Known for high-quality APIs, including phenothiazine derivatives like fluphenazine, with multiple certifications supporting export.

• Aarti Drugs: Offers a broad portfolio of APIs, including antipsychotics, with manufacturing facilities complying with international standards.

These companies support a robust export pipeline, primarily catering to North America, Europe, and emerging markets.

China

Chinese firms are significant API suppliers in the phenothiazine class, with notable companies including:

• Zhejiang Xianju Pharmaceutical Co., Ltd.: Provides bulk APIs with competitive pricing, with a growing emphasis on quality standards aligning with international regulations.

• Shandong Luwei Pharmaceutical Co., Ltd.: Offers fluphenazine API for export, often fulfilling custom manufacturing needs.

Chinese API manufacturers tend to be valued for cost-efficiency but are increasingly adopting stricter quality controls to meet global regulatory expectations.

Other Notable Regions

While less prominent, manufacturers from Europe and North America supply high-purity APIs, mainly for markets with stringent regulatory requirements, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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Quality Standards and Regulatory Considerations

For bulk API procurement, compliance with regulatory standards is vital. The most sought-after sources maintain certifications such as:

• WHO-GMP (World Health Organization Good Manufacturing Practices)
• US FDA Approval (for manufacturing facilities)
• EU GMP Certification

These standards ensure the API's chemical purity, stability, and safety, aligning with quality attributes needed for pharmaceutical formulation.

Many manufacturers offer Certificates of Analysis (CoA) and batch-specific analytical data to authenticate API quality during procurement processes.

Market Dynamics and Trends

The API market for antipsychotics like fluphenazine faces several trends:

• Regulatory Stringency: Increasing quality standards, especially following the 2019 US Drug Supply Chain Security Act, necessitate rigorous supplier audits.

• Supply Chain Consolidation: Larger manufacturers acquire or Partner with smaller API producers to streamline supply chains, improve quality, and reduce costs.

• Geopolitical Considerations: Ongoing trade tensions influence sourcing, prompting pharmaceutical companies to diversify supply sources across regions.

• Cost Pressures: Indian and Chinese suppliers remain competitive, although quality premiums are observed among high-purity providers.

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Supplier Selection Criteria

When sourcing API for PROLIXIN, stakeholders should prioritize:

• Quality Certifications: Prioritize suppliers with WHO-GMP, FDA, or EMA approvals.
• Regulatory Track Record: Verified compliance history and ability to support regulatory submissions.
• Supply Stability: Proven manufacturing capacity and contingency planning.
• Analytical Data Transparency: Availability of detailed CoA, impurity profiles, and stability data.
• Cost-effectiveness: Competitive pricing without compromising quality.

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Supply Chain Challenges and Risk Mitigation

Several challenges impact the sourcing of fluphenazine API:

• Healthcare Regulation Variations: Different countries’ regulations influence the choice of suppliers, especially regarding data requirements.
• Manufacturing Disruptions: Political instability, COVID-19 related disruptions, and natural events can threaten supply continuity.
• Intellectual Property and Patent Status: While fluphenazine is off-patent, manufacturers must ensure freedom-to-operate and compliance with patent laws in specific markets.

Mitigation strategies include multi-sourcing, maintaining quality audits, and engaging with reputable CMOs.

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Major API Suppliers for PROLIXIN: Summary Table

Supplier Name	Country	Certifications	Approximate Capacity	Market Focus
Macleods Pharmaceuticals	India	WHO-GMP, US-FDA, EMA	High	Global
Divi's Laboratories	India	WHO-GMP, US-FDA, EMA	High	Developed and emerging markets
Aarti Drugs	India	WHO-GMP	Moderate	Asia, Africa, Latin America
Zhejiang Xianju Pharmaceutical	China	ISO, CE, GMP	Moderate	Asia, global compliance
Shandong Luwei Pharmaceutical	China	GMP, ISO	Moderate	Cost-sensitive regions

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Conclusion

Sourcing high-quality API for PROLIXIN necessitates vigilant supplier evaluation, adherence to regulatory standards, and strategic supply chain management. Indian and Chinese API manufacturers dominate the landscape, offering a balance of quality and cost-efficiency. Ensuring compliance with international certification standards remains paramount, especially for manufacturers supplying developed markets with stringent regulatory requirements. Diversifying supplier portfolios and establishing quality assessment protocols will mitigate risks associated with geopolitical and supply chain disruptions.

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Key Takeaways

• India and China lead as primary suppliers of fluphenazine API, with a growing emphasis on quality certifications to meet global standards.
• Regulatory compliance, including WHO-GMP and FDA approval, is critical when selecting API sources for PROLIXIN.
• Supply chain resilience depends on multi-sourcing strategies and supplier audits, especially amid geopolitical and pandemic-related disruptions.
• Market trends suggest increasing quality controls and certification standards will influence future API sourcing decisions.
• Due diligence in analytical documentation and certification verification ensures consistent API quality and regulatory compliance.

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FAQs

1. Are there US or European manufacturers of fluphenazine API?
Yes. While Indian and Chinese firms dominate, some European and North American companies produce high-purity APIs for regulatory-compliant markets, often catering to specialty markets and formulations requiring advanced quality assurance.

2. What certifications should I verify before sourcing API for PROLIXIN?
Manufacturers should have WHO-GMP, US FDA approval, EU GMP, or equivalent certifications. Suppliers' Certificates of Analysis (CoA) and analytical validation data are also essential.

3. How does geopolitical stability impact API sourcing?
Trade tensions and geopolitical instability can disrupt supply chains, prompting companies to diversify sources across regions to mitigate risks.

4. Is cost the primary consideration when choosing an API supplier?
While cost is significant, quality, regulatory compliance, supplier reliability, and ability to meet timelines are equally, if not more, important to ensure product safety and regulatory approval.

5. Can I verify supplier quality independently?
Yes. Conducting audits, requesting detailed CoA, and collaborating with third-party analytical laboratories can verify API quality before procurement.

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References

[1] Pharmacopoeias and regulatory agency guidelines.
[2] Market data from Global Market Insights, 2022.
[3] Supplier certifications and public disclosures.
[4] Industry reports on API manufacturing and supply chain dynamics.