Bulk Pharmaceutical API Sources for ALFENTA

Bulk Pharmaceutical API Sources for ALFENTA

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS015966535
Sigma-Aldrich		A-071_CERILLIAN
Ambinter		Amb19130349
Ambinter		Amb22734364
Synblock Inc		SB17329
Synblock Inc		SB17330

Bulk Active Pharmaceutical Ingredient (API) Sources for ALFENTA (Alfentanil)

Last updated: July 30, 2025

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Introduction

Alfentanil, marketed under the brand name ALFENTA, is a potent synthetic opioid analgesic primarily used in anesthesia for its rapid onset and short duration of action. As a crucial component in anesthetic protocols, the quality and reliability of its active pharmaceutical ingredient (API) supply are vital for consistent clinical outcomes and regulatory compliance. This article examines the primary sources of bulk alfentanil API, key manufacturers, sourcing considerations, and strategic implications for pharmaceutical companies and healthcare providers.

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Overview of Alfentanil API Manufacturing

The synthesis of alfentanil involves complex chemical processes requiring high precision to ensure potency, purity, and stability. Due to its potent opioid nature, manufacturing procedures must adhere to strict Good Manufacturing Practice (GMP) standards. Several specialized pharmaceutical API producers globally manufacture alfentanil, catering both to generic and branded markets.

Leading API Manufacturers of Alfentanil

1. Multiple-Sourcing Strategies

Given the sensitive nature of opioid APIs, pharmaceutical companies typically engage multiple suppliers to mitigate risks related to supply disruptions, regulatory changes, or quality issues.

2. Major Global API Suppliers for Alfentanil

a. Hikma Pharmaceuticals

Hikma, based in Jordan, is a prominent generic pharmaceutical manufacturer with extensive expertise in anesthesia APIs, including alfentanil. They possess robust GMP-certified facilities capable of producing high-quality bulk alfentanil API for both local and international markets^[1].

b. Fresenius Kabi

A global healthcare company from Germany, Fresenius Kabi specializes in anesthetic and analgesic APIs. They source alfentanil API from verified suppliers with proven compliance to international quality standards, often manufacturing or distributing their own API batches^[2].

c. Switch Pharma

Based in South Africa, Switch Pharma has established a reputation for producing high-quality opioid APIs, including alfentanil, with stringent adherence to regulatory standards. They serve markets in Africa and emerging regions, providing reliable supply channels^[3].

d. Indication of Indian Manufacturers

India hosts several API manufacturers known for producing APIs under stringent GMP conditions:

• Sun Pharma: Has capabilities to produce specialty APIs, including opioids, for domestic and export markets, often sourcing alfentanil API from internationally certified suppliers^[4].
• Cipla and Wockhardt: Despite primarily focusing on finished formulations, some Indian API firms provide alfentanil intermediate or finished API with GMP compliance, often imported from certified global suppliers.

e. Chinese Manufacturers

The Chinese pharmaceutical industry plays a significant role in APIs' global supply chain:

• Hengjian Pharmaceutical and Qilu Pharmaceutical have reportedly manufactured alfentanil API, complying with international standards, primarily for export markets. Due diligence is necessary given the varying levels of GMP compliance^[5].

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Regulatory and Quality Considerations

• GMP Certification: Confirm that suppliers hold valid GMP certificates recognized by regulatory authorities such as the FDA (USA), EMA (Europe), or WHO prequalification programs.
• Certificate of Analysis (CoA): Essential documentation verifying purity (>99%), absence of contaminants, and compliance with pharmacopoeial standards.
• Supply Chain Integrity: Traceability and adherence to strict supply chain protocols are critical to prevent counterfeit or substandard API entry into the pharmaceutical supply chain.

Sourcing Strategies

• Direct Procurement from Manufacturers: Engaging directly with established API manufacturers offers better quality control, pricing, and supply security.
• Through Distributors and Brokers: Sometimes necessary in regional markets but requires rigorous due diligence regarding authenticity and quality certification.
• Contract Manufacturing Organizations (CMOs): Collaborating with CMOs allows pharmaceutical companies to outsource API synthesis, ensuring supply flexibility while maintaining quality standards.

Global Supply Chain Trends and Risks

• Supply Disruptions: Political instability, COVID-19 pandemic effects, or regulatory shifts can impact API availability.
• Regulatory Scrutiny: Increasing regulations surrounding opioid APIs, especially in Europe and North America, necessitate strong compliance documentation.
• Price Volatility: The concentrated supply base and regulatory restrictions can influence API pricing, affecting overall production costs.

Emerging Alternatives and Innovations

Given the opioid crisis and regulatory rigor, some market players explore:

• Synthetic Alternatives: Developing or sourcing alternative molecules that mimic alfentanil properties with potentially less regulatory scrutiny.
• Enhanced API Quality: Advances in synthesis techniques improve purity and reduce impurities, meeting tighter pharmacopoeial standards.

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Conclusion

The bulk sourcing of alfentanil API involves navigating a complex landscape of global manufacturers, regulatory standards, and supply chain risks. Leading API producers include Hikma Pharmaceuticals, Fresenius Kabi, Switch Pharma, and select Indian and Chinese manufacturers. Ensuring GMP compliance, traceability, and robust quality assurance processes is vital for healthcare providers and pharmaceutical companies relying on alfentanil. Strategic diversification of sources and adherence to regulatory standards underpin a resilient supply chain, especially amid global challenges.

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Key Takeaways

• Multiple reputable manufacturing sources support the global supply of alfentanil API, with key players in Jordan, Germany, South Africa, India, and China.
• Ensuring GMP certification, comprehensive documentation, and supply chain integrity is critical for procurement.
• Diversifying suppliers mitigates risks associated with geopolitical, regulatory, or pandemic-driven disruptions.
• Regulatory compliance and quality assurance influence market access and pricing.
• Continuous monitoring of emerging manufacturing technologies and supply chain trends can optimize procurement strategies.

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Frequently Asked Questions (FAQs)

1. What are the primary qualities to verify when sourcing alfentanil API?
Qualities such as >99% purity, certified GMP compliance, a valid Certificate of Analysis, and traceability are essential for safe and effective use.

2. Which regions dominate the production of alfentanil API?
Major production regions include Europe (e.g., Germany), Asia (India and China), and South Africa, with emerging sources in the Middle East and Latin America.

3. How does regulatory compliance influence sourcing choices?
Regulatory standards directly impact supplier credibility; sourcing from GMP-certified manufacturers ensures compliance with local and international laws, facilitating market access.

4. What are the risks associated with sourcing from Chinese or Indian API manufacturers?
Potential risks include variable GMP compliance, regulatory differences, and quality control challenges, underscoring the importance of rigorous supplier qualification.

5. How can pharmaceutical companies ensure a reliable supply of alfentanil API?
Engage multiple verified suppliers, establish long-term agreements, maintain safety stock levels, and regularly conduct quality audits to ensure continuous supply.

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References

[1] Hikma Pharmaceuticals. Product Portfolio and Manufacturing Capabilities, 2023.
[2] Fresenius Kabi. Annual Report, 2022.
[3] Switch Pharma. Corporate Overview and API Supply, 2023.
[4] Sun Pharma. API Production and Quality Standards, 2022.
[5] Chinese Pharmaceutical Industry Reports, 2022.

Note: Data above synthesized from publicly available industry reports and company disclosures, emphasizing the importance of due diligence.