Bulk Pharmaceutical API Sources for FENTANYL CITRATE PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for FENTANYL CITRATE PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		13810
ABI Chem		AC1L22J8
ABI Chem		AC1Q5SOC
ChemMol		49415087
ChemMol		97900358
Chembase.cn		131217

Last updated: August 5, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: FENTANYL CITRATE PRESERVATIVE-FREE

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Introduction

Fentanyl citrate, a potent synthetic opioid analgesic, is widely used in clinical settings for the management of severe acute and chronic pain. Its high potency necessitates strict manufacturing standards, especially for preservative-free formulations intended for injectable or transdermal applications. The quality and reliability of bulk API sources critically influence drug safety, efficacy, and regulatory compliance. This article provides a comprehensive overview of global suppliers offering preservative-free fentanyl citrate bulk APIs, emphasizing supplier credibility, regulatory standing, and supply chain robustness.

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Overview of Fentanyl Citrate API Manufacturing

Manufacturing fentanyl citrate involves sophisticated chemical synthesis typically performed by specialized pharmaceutical manufacturers with stringent quality controls. The process begins with precursor chemicals, followed by multiple reaction and purification steps to ensure high purity and consistency. Producing preservative-free fentanyl citrate API adds complexity, requiring contamination-free environments to eliminate potential preservatives or stabilizers.

Global manufacturers are classified based on their regulatory certifications (e.g., FDA, EMA, PMDA) and adherence to Good Manufacturing Practices (GMP). Vendors supplying APIs for injectable formulations must maintain rigorous quality standards, given the drug's potency and potential misuse risks.

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Major Global API Suppliers for Fentanyl Citrate (Preservative-Free)

1. Johnson Matthey PLC

Johnson Matthey is a leading specialty chemicals and pharmaceutical excipients provider recognized for its high-quality APIs, including fentanyl citrate. With facilities compliant with global GMP standards and strict quality assurance protocols, Johnson Matthey supplies APIs to major pharmaceutical firms worldwide. Their expertise extends into custom synthesis, ensuring preservative-free formulations meet purity and safety criteria.

Notable Points:

• Certified under US FDA and EMA GMP.
• Robust supply chain for clinical trial and commercial demand.
• Emphasis on high purity and consistent manufacturing processes.

2. Shanghai Institute of Organic Chemistry (SIOC)

Part of the Chinese Academy of Sciences, SIOC specializes in the synthesis of complex organic compounds, including opioids and related APIs. SIOC’s production facilities have achieved GMP certification, and they supply fentanyl citrate API tailored for preservative-free formulations.

Notable Points:

• Focus on research-grade and GMP-grade APIs.
• Competitive pricing with growing export capacity.
• Emphasis on technological innovation in synthesis processes.

3. Albemarle Corporation

Albemarle, a prominent player in specialty chemicals, offers fentanyl citrate APIs sourced from rigorous manufacturing processes. Their APIs are utilized globally in pharmaceutical manufacturing, including preservative-free injectable formulations. The company’s adherence to international standards ensures high-quality, contaminant-free APIs.

Notable Points:

• GMP-certified facilities across North America and Europe.
• Proven supply stability and regulatory compliance.
• Extensive APIs portfolio with strict quality controls.

4. Zhejiang Hisun Pharmaceutical Co., Ltd.

A leading Chinese pharmaceutical manufacturer, Hisun Pharmaceutical produces APIs, including fentanyl citrate, with a focus on quality and safety. Their API manufacturing facilities are certified by the Chinese Food and Drug Administration (CFDA) and aligned with international GMP standards.

Notable Points:

• Focus on the opioid API market for global export.
• Competitive pricing for large-volume orders.
• Emphasis on preservative-free formulations to meet global demand.

5. Indchemie Healthchem Ltd.

An Indian API producer with facilities compliant with WHO-GMP standards, Indchemie manufactures fentanyl citrate for global markets. Their API quality is verified through rigorous testing and regulatory audits, ensuring suitability for preservative-free injectable drugs.

Notable Points:

• Approved by leading regulatory agencies in India and abroad.
• Focused on customer-centric manufacturing and supply.
• Offerings include custom synthesis for specialized formulations.

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Emerging Suppliers and Considerations

While the above-mentioned companies dominate the market, several emerging suppliers from regions like Southeast Asia and Eastern Europe are beginning to expand their offerings of fentanyl citrate APIs. However, due diligence regarding GMP compliance, regulatory acceptance, and supply reliability is essential when engaging with newer vendors.

Key considerations include:

• Verification of GMP and regulatory certifications (FDA, EMA, Health Canada, etc.).
• Validation of quality specifications, including purity, potency, and absence of preservatives.
• Supply chain transparency and ability to meet global demand fluctuations.

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Regulatory and Quality Assurance Aspects

API sourcing for sensitive drugs like fentanyl citrate mandates adherence to stringent regulatory standards. Suppliers must demonstrate compliance through documentation such as GMP certificates, batch records, and analytical testing reports (HPLC purity, residual solvents, endotoxin levels). For preservative-free APIs, additional validation ensures the absence of stabilizers, preservatives, or contaminants.

Pharmaceutical companies must perform vendor audits, incorporating site inspections and analytical validation, to mitigate risks associated with counterfeit or substandard APIs. Regulatory agencies increasingly scrutinize supply chains, emphasizing traceability, especially for opioids.

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Supply Chain and Logistics Considerations

The global distribution of fentanyl citrate APIs presents logistical challenges due to the drug’s high potency and regulatory controls. Vendors with integrated logistics frameworks, including customs clearance expertise and secure transportation, provide a strategic advantage.

Supply chain robustness is vital to prevent shortages, particularly during surges in global demand, such as during the COVID-19 pandemic, which stressed pharmaceutical supply chains worldwide. Vendors with contingency plans, diversified manufacturing sites, and ISO-certified quality management systems ensure continuity.

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Key Challenges in Sourcing Preservative-Free Fentanyl Citrate API

• Regulatory Restrictions: Many countries impose strict controls on opioid raw materials, complicating procurement.
• Quality Assurance: Ensuring preservative-free status requires comprehensive analytical validation and supplier compliance.
• Price Fluctuations: Market volatility and regulatory shifts influence API pricing and supply stability.
• Intellectual Property (IP): Proprietary synthesis processes may limit access to certain APIs or impose licensing restrictions.

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Conclusion

The global landscape of fentanyl citrate API supply for preservative-free formulations is characterized by a handful of reputable manufacturers with established GMP certification and regulatory compliance. Leading companies like Johnson Matthey, Albemarle, and Chinese pharmaceutical manufacturers such as Zhejiang Hisun provide diverse options for pharmaceutical developers seeking reliable, high-quality APIs.

Ensuring product quality, regulatory adherence, and supply chain stability is paramount. Due diligence combined with strategic supplier selection enables pharmaceutical companies to mitigate risks and meet the growing demand for safe, preservative-free fentanyl citrate products.

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Key Takeaways

• Trusted Suppliers: Focus on GMP-certified, regulatory-compliant manufacturers like Johnson Matthey, Albemarle, and leading Chinese API producers.
• Quality Assurance: Validate APIs via analytical testing to confirm preservative-free status and high purity levels.
• Regulatory Compliance: Ensure vendors have appropriate certifications and documentation to meet international standards.
• Supply Chain Resilience: Prioritize suppliers with diversified manufacturing and logistics capabilities to prevent disruptions.
• Market Dynamics: Monitor geopolitical and regulatory changes affecting opioid raw material sourcing to maintain compliance and supply stability.

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Frequently Asked Questions (FAQs)

1. Can I source preservative-free fentanyl citrate API from emerging markets?
Yes, several emerging markets like India and China produce fentanyl citrate APIs, including preservative-free formulations. However, rigorous due diligence regarding GMP compliance, quality standards, and regulatory approvals is essential to ensure safety and efficacy.

2. What quality certifications should I verify before purchasing fentanyl citrate API?
Verify GMP certification, analytical validation reports, and regulatory approvals such as FDA, EMA, or equivalent. These ensure the API meets purity, potency, and safety standards.

3. Are there specific challenges related to the large-scale procurement of fentanyl citrate APIs?
Yes, due to regulatory restrictions, high potency, and potential for diversion, procurement often involves complex licensing, strict documentation, and adherence to controlled substance regulations, ensuring secure logistics and compliance.

4. How do I validate that the API is preservative-free?
Request comprehensive analytical reports, including HPLC purity testing and residual solvent analysis. Confirm from the supplier that no preservatives or stabilizers are used during synthesis or packaging.

5. What role does supply chain security play in sourcing fentanyl citrate API?
Supply chain integrity is critical given the controlled status of opioids. Reliable vendors with validated logistics, diversified manufacturing sites, and contingency plans safeguard against shortages and regulatory scrutiny.

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References

[1] US Food and Drug Administration (FDA). "Guidance for Industry: Good Manufacturing Practices for Drugs".

[2] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice".

[3] International Pharmaceutical Excipients Council. "Handling of High- potency APIs".

[4] Johnson Matthey. Product Information Sheets on Fentanyl APIs.

[5] Zhejiang Hisun Pharmaceutical Co., Ltd. Official Website.

[6] Chinese Food and Drug Administration (CFDA). Certification and Compliance Data.