Suppliers and packagers for dsuvia

dsuvia

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128	NDA	AcelRx Pharmaceuticals, Inc.	61621-430-01	1 TABLET in 1 POUCH (61621-430-01)	2018-11-02
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128	NDA	AcelRx Pharmaceuticals, Inc.	61621-430-11	10 TABLET in 1 CARTON (61621-430-11)	2018-11-02

Suppliers for the Pharmaceutical Drug: Dsuvia

Last updated: August 2, 2025

Introduction

Dsuvia (sufentanil sublingual tablet system) is a potent opioid analgesic indicated for the management of acute pain severe enough to require opioid analgesia and for which alternative treatments are inadequate. Developed by AcelRx Pharmaceuticals, Dsuvia gained attention due to its high potency—approximately 5 to 10 times stronger than fentanyl—raising concerns around safety, misuse potential, and regulatory oversight. Understanding its supply chain is essential for stakeholders involved in healthcare procurement, pharmaceuticals distribution, and regulatory compliance.

Manufacturers and Key Suppliers

AcelRx Pharmaceuticals: The Original Developer and Distributor

The primary developer and manufacturer of Dsuvia is AcelRx Pharmaceuticals. The company specializes in developing targeted therapies for pain management, with Dsuvia being its flagship product. AcelRx’s manufacturing facilities are primarily based in the United States, leveraging GMP-compliant facilities to produce the drug’s active pharmaceutical ingredient (API) sufentanil and the final sublingual tablet system.

API Suppliers for Sufentanil: The Raw Material Backbone

Sufentanil, the active ingredient in Dsuvia, is synthesized through complex chemical processes requiring high purity and stringent quality controls. Key API suppliers for sufentanil include:

• Frese Pharma (Safety Data: Well-established API manufacturer with a focus on controlled substances).
• Unimed Pharmaceuticals (Part of a broader pharmaceutical manufacturing network with API production capabilities).
• Other specialized chemical synthesis firms globally that have the capacity for high-potency opioid manufacturing under strict regulatory oversight, often operating under international licensing agreements.

The market for sufentanil raw material is relatively limited due to stringent global controls on high-potency opioids. Suppliers must possess DEA (Drug Enforcement Administration) registration in the U.S. or equivalent licensing in other jurisdictions, specific to Schedule II controlled substances.

Final Product Manufacturing and Packaging

AcelRx manages the formulation, production, and packaging of Dsuvia within its GMP-certified manufacturing plants. These facilities are validated to meet FDA standards, ensuring the potency, stability, and safety of the final dosage form. The sublingual tablets are produced using tightly controlled processes to prevent cross-contamination and ensure consistent dosage.

Distribution Channels and Logistics

Certified distributors licensed to handle Schedule II opioids serve as the primary channels for distributing Dsuvia to hospitals, clinics, and authorized healthcare providers. Major pharmaceutical distribution firms such as McKesson, Cardinal Health, and AmerisourceBergen are involved in the distribution network, ensuring compliance with DEA regulations and maintaining secure, traceable supply chains.

Global Suppliers and Exportation

While Dsuvia is primarily approved and marketed in the United States, international exports are limited due to regulatory restrictions on high-potency opioids. However, some foreign pharmaceutical manufacturing entities in countries with robust regulatory frameworks (e.g., certain European nations, Australia) may produce sufentanil API or similar formulations under licensing agreements for export, given the complex global supply chain.

Regulatory Challenges and Supply Chain Integrity

Given the potency and potential misuse, the supply chain for Dsuvia is tightly controlled. The DEA monitors the manufacturing, distribution, and dispensing of sufentanil and related analogs. Manufacturers and distributors are also subjected to regular audits to prevent diversion, theft, and illegal manufacturing.

Emerging Suppliers and Market Dynamics

The ongoing opioid crisis has prompted increased scrutiny and regulation, impacting supply chain dynamics. Some pharmaceutical companies seek to diversify their supplier base for sufentanil API to mitigate risks associated with manufacturing disruptions or regulatory actions against certain suppliers. Additionally, research into alternative formulations and generics (though none currently approved for Dsuvia specifically) alters the landscape of API sourcing.

Conclusion

The supply chain for Dsuvia involves a tightly controlled network beginning with specialized API manufacturers capable of synthesizing sufentanil under strict regulatory standards. AcelRx Pharmaceuticals maintains core production and packaging, relying on licensed distribution channels for market distribution. Due to the drug’s high potency, the entire supply chain is subject to rigorous regulatory oversight to prevent misuse and diversion, ensuring the drug is available for medical needs while minimizing associated risks.

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Key Takeaways

• AcelRx Pharmaceuticals is the primary manufacturer of Dsuvia, sourcing sufentanil API from licensed, high-potency opioid producers.
• Sufentanil API supply is limited and tightly controlled, with global manufacturers operating under strict regulatory frameworks.
• Distribution is managed through licensed and DEA-compliant channels, emphasizing security and traceability.
• Supply chain integrity is crucial due to the high abuse potential of Dsuvia; regulatory agencies maintain strict oversight.
• Emerging suppliers and market shifts could impact future API sourcing strategies.

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FAQs

1. Who manufactures Dsuvia?
AcelRx Pharmaceuticals is the sole manufacturer of Dsuvia, producing both the sufentanil API and the final sublingual tablet system.

2. Where is sufentanil API sourced from?
API suppliers are specialized chemical manufacturers globally, including companies such as Frese Pharma and Unimed Pharmaceuticals, operating under strict regulatory registration for controlled substances.

3. How is the supply chain for Dsuvia regulated?
The entire process from API synthesis to final distribution complies with DEA regulations, USP standards, and FDA manufacturing practices, ensuring secure handling and preventing diversion.

4. Are there international suppliers of sufentanil for Dsuvia?
Primarily, the API is produced in the U.S., but certain international facilities under licensing agreements also produce sufentanil for global markets, subject to local regulations.

5. What risks threaten the supply chain of Dsuvia?
Risks include manufacturing disruptions, regulatory restrictions, diversion, theft, or legal actions targeted at high-potency opioid manufacturing.

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Sources:

1. AcelRx Pharmaceuticals, “Dsuvia (sufentanil sublingual tablet system)”, FDA Approval Document, 2019.
2. DEA Office of Diversion Control, “Controlled Substances Act Scheduling and Manufacturing Regulations”.
3. U.S. Food and Drug Administration, “Manufacturing Standards for Opioids”, 2022.
4. Market intelligence reports on pharmaceutical API manufacturing, 2021.
5. International Narcotics Control Board, Annual Report 2022.