Bulk Pharmaceutical API Sources for DSUVIA

Bulk Pharmaceutical API Sources for DSUVIA

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		41693
ABI Chem		AC1L26AJ
ABI Chem		AC1Q5I7B
Chembase.cn		589

Bulk Active Pharmaceutical Ingredient (API) Sources for DSUVIA

Last updated: July 28, 2025

Introduction

DSUVIA (sufentanil sublingual tablet) represents a highly potent opioid analgesic approved by the U.S. Food and Drug Administration (FDA) for managing severe, acute pain in emergency and surgical settings. As a medication containing sufentanil—a synthetic opioid approximately 5 to 10 times more potent than fentanyl—the integrity of its manufacturing process hinges on sourcing high-quality bulk Active Pharmaceutical Ingredients (APIs). Ensuring a reliable supply chain for sufentanil API is critical not only for regulatory compliance but also for safety, efficacy, and consistent patient outcomes. This report critically examines the primary sources of sufentanil API globally, highlighting manufacturing profiles, regulatory considerations, and the strategic significance for pharmaceutical supply chains.

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Understanding Sufentanil API

Sufentanil is a synthetic opioid analgesic belonging to the fentanyl class. Its potent central nervous system activity necessitates stringent handling, quality control, and sourcing protocols at the bulk API level. Typically produced via complex organic synthesis, sufentanil API's manufacturing process requires specialized facilities with high containment and quality assurance capabilities.

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Global Landscape of API Suppliers for Sufentanil

1. Major Manufacturer Profile: Jiangsu Hengrui Medicine Co., Ltd. (China)

Jiangsu Hengrui Medicine is among the notable Chinese pharmaceutical companies producing fentanyl derivatives, including sufentanil API. Known for robust manufacturing infrastructure, Hengrui has established extensive regulatory and process validation protocols aligned with international standards.

• Manufacturing Capabilities: Large-scale synthesis, GMP certification, comprehensive quality management.
• Regulatory Status: Approved by Chinese authorities; seeking or maintaining WHO-GMP certification.
• Supply Reliability: Historically consistent, but geopolitical factors may influence supply stability.

2. Johnson Matthey (United Kingdom / Global Operations)

Johnson Matthey, a renowned leader in fine chemicals and pharmaceutical manufacturing, supplies high-purity APIs, including fentanyl derivatives like sufentanil, primarily for research and specialized medical applications.

• Manufacturing Capabilities: Advanced chemical synthesis, high-purity API production, tailored formulations.
• Regulatory Framework: Compliant with EMA and FDA standards; extensive auditing.
• Supply Chain Considerations: Known for supply stability, though capacity constraints could arise given high demand.

3. Bright Moon Pharmaceutical (China)

Bright Moon Pharmaceutical, based in China, is a significant manufacturer specializing in opioid APIs and formulations for global markets.

• Manufacturing Profile: GMP-compliant facilities, with a focus on opioids.
• Market Presence: Supplies to several international markets; regulatory recognition varies.
• Supply Status: Capable of large-scale production; recent initiatives aim to elevate quality standards.

4. Indirect Sources: Contract Manufacturing Organizations (CMOs)

Outside direct manufacturer facilities, several CMOs in India, China, and Europe provide custom synthesis of sufentanil API, emphasizing scalability and compliance. Examples include:

• Neuland Laboratories (India): Known for opioid APIs, adhering to strict quality procedures.

• Hanlim Pharmaceutical (South Korea): Offers advanced manufacturing services for potent APIs with high regulatory compliance.

These CMOs often operate under strict confidentiality agreements and supply dense regulatory markets, including North America and Europe.

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Manufacturing and Regulatory Challenges

Ensuring API quality involves meticulous process validation, raw material sourcing, and adherence to Good Manufacturing Practices (GMP). Because sufentanil is a Schedule II controlled substance in many jurisdictions, manufacturers face rigorous oversight, including DEA registration in the U.S. and corresponding agencies elsewhere.

• Compliance: All suppliers must implement robust security and documentation protocols.
• Traceability: Batch records, stability data, and analytical method validation are vital.
• Regulatory Approvals: Suppliers seeking to export to the U.S. market need DEA licensing and FDA registration, which involve periodic audits and compliance checks.

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Supply Chain Considerations

The global supply of sufentanil API remains concentrated among a handful of manufacturers due to the complex synthesis involved. Key considerations include:

• Regulatory Harmonization: Divergent regulatory standards can delay approvals. Suppliers with international certifications tend to be favored.
• Geopolitical Risks: Trade restrictions or sanctions, notably related to Chinese and Indian suppliers, can impact availability.
• Capacity and Scalability: Sudden increases in demand for DSUVIA or similar products could strain existing API supplies.

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Quality Assurance and Risk Management

Due to sufentanil’s potency, suppliers must:

• Maintain rigorous testing protocols, including High-Performance Liquid Chromatography (HPLC) and Gas Chromatography-Mass Spectrometry (GC-MS).
• Validate impurity profiles to prevent adverse events.
• Ensure data integrity and batch-to-batch consistency.

Pharmaceutical companies sourcing sufentanil API should engage with suppliers demonstrating:

• GMP compliance
• Recent audit reports
• Transparent supply chain mapping
• Validated analytical methods

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Emerging Trends and Strategic Outlook

The increasing demand for potent opioids like sufentanil in clinical settings underscores the necessity for diversified sourcing strategies. Some key trends include:

• Vertical Integration: Manufacturers are investing in internal API production lines to mitigate supply disruptions.
• Regulatory Developments: Stringent controls on opioid APIs are likely to tighten globally, favoring suppliers with robust compliance histories.
• Technological Advances: Process innovations aim to improve yield, reduce impurities, and enhance safety profiles in API manufacturing.

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Key Takeaways

• The primary sources of sufentanil API are concentrated among Chinese companies like Jiangsu Hengrui Medicine and Bright Moon Pharmaceutical, as well as European and Indian CMOs.
• Ensuring supplier GMP certification, regulatory compliance, and traceability is vital for maintaining supply chain integrity.
• Geopolitical factors and regulatory complexities influence API availability, necessitating strategic supplier diversification.
• High manufacturing standards and rigorous quality assurance are crucial due to the potency and safety concerns associated with sufentanil.
• Future supply stability depends on capacity expansion, regulatory transparency, and technological advancements in synthesis.

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FAQs

1. What are the major regions producing sufentanil API for DSUVIA?
Primarily China and Europe, with key manufacturers including Jiangsu Hengrui Medicine and Johnson Matthey. Indian CMOs also contribute to global supply chains.

2. How does regulatory oversight impact sufentanil API sourcing?
Strict compliance with GMP, DEA, and FDA regulations ensures safety and legal manufacturing. Regulatory approval facilitates wider international distribution.

3. What challenges are associated with sourcing sufentanil API?
Limited producers due to complex synthesis, geopolitical restrictions, and stringent regulations can cause supply disruptions.

4. How do quality standards differ among API suppliers?
Suppliers adhering to international GMP standards and possessing recent audit certifications are more reliable for consistent quality.

5. What strategies can pharmaceutical companies employ to ensure a stable sufentanil API supply?
Diversify supplier base, establish long-term supply agreements, and work with certified CMOs to mitigate risks.

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References

[1] U.S. FDA. "DSUVIA (sufentanil sublingual tablets) prescribing information." 2019.
[2] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice." 2020.
[3] International Narcotics Control Board. "Opioid Production Report." 2022.
[4] Johnson Matthey. "High-Purity APIs for Critical Care." Company brochure. 2022.
[5] Jiangsu Hengrui Medicine Co., Ltd. Annual Report. 2022.