Suppliers and packagers for generic pharmaceutical drug: SODIUM OXYBATE

SODIUM OXYBATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755	NDA	Avadel CNS Pharmaceuticals, LLC	13551-001-07	7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET	2023-05-01
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755	NDA	Avadel CNS Pharmaceuticals, LLC	13551-001-30	30 PACKET in 1 CARTON (13551-001-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET	2023-05-01
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755	NDA	Avadel CNS Pharmaceuticals, LLC	13551-002-07	7 PACKET in 1 CARTON (13551-002-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET	2023-05-01

Suppliers for the Pharmaceutical Drug: Sodium Oxybate

Last updated: July 31, 2025

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Introduction

Sodium oxybate, also known as gamma-hydroxybutyrate (GHB), is a central nervous system depressant used primarily in treating narcolepsy with cataplexy under the brand name Xyrem. Its unique pharmacological profile necessitates strict regulatory controls and sophisticated manufacturing protocols. Given its importance in narcolepsy management, understanding its supply chain is crucial for pharmaceutical companies, healthcare providers, and regulatory agencies. This article explores the key suppliers involved in the sourcing, production, and distribution of sodium oxybate, emphasizing regulatory compliance, manufacturing sources, and global availability.

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Regulatory Landscape and Supplier Regulation

Sodium oxybate’s status as a controlled substance under the U.S. Drug Enforcement Administration (DEA) Schedule III classification necessitates stringent oversight. Similar regulations exist globally, including in Europe under the European Medicines Agency (EMA) and various national agencies. Suppliers must adhere to Good Manufacturing Practices (GMP), ensuring product quality, purity, and safety.

The primary supplier landscape includes proprietary manufacturers with licensed manufacturing agreements, generic chemical suppliers, and specialized pharmaceutical ingredient producers. Regulatory approval processes require comprehensive documentation of manufacturing processes, potency consistency, and impurity profiles.

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Key Suppliers and Manufacturers of Sodium Oxybate

1. Jazz Pharmaceuticals

Market Dominance as a Proprietary Manufacturer:
Jazz Pharmaceuticals, under the brand Xyrem, is the sole commercial manufacturer of sodium oxybate for medical use in the United States and many other jurisdictions, following FDA approval. The company manufactures the pharmaceutical-grade compound under rigorous GMP standards at their facilities and holds exclusive rights to distribute the product in numerous markets.

Manufacturing and Supply Chain Control:
Jazz’s exclusive manufacturing creates a controlled supply chain, minimizing risks of contamination, adulteration, or illegal diversion. The complex manufacturing involves synthesis, purification, and formulation processes compliant with regulatory standards—making Jazz the primary source for pharmaceutical-grade sodium oxybate.

2. Generic and Chemical Ingredient Suppliers

2.1. Chemical Niche Suppliers and Contract Manufacturers
While Jazz Pharmaceuticals controls the global supply in finished form, several chemical suppliers produce raw gamma-butyrolactone (GBL) or gamma-hydroxybutyric acid (GHB) as intermediates. These companies supply bulk raw materials, primarily to licensed manufacturers or research establishments.

2.2. Major Chemical Suppliers
Leading chemical corporations like Cayman Chemicals, Toronto Research Chemicals, and other specialty chemical suppliers produce high-purity gamma-hydroxybutyric acid, which is subsequently converted into sodium oxybate under licensed manufacturing arrangements. Many of these suppliers operate under strict compliance regimes to meet GMP and other quality standards.

3. Contract Manufacturing Organizations (CMOs)

Given the complex synthesis required, pharmaceutical companies often outsource production to specialized CMOs globally. These organizations possess the requisite facilities, expertise, and regulatory approval to produce pharmaceutical-grade sodium oxybate for licensed pharmaceutical companies.

Examples include:

• Patheon (part of Thermo Fisher Scientific)
• Bosch HealthCare
• Other regional GMP-certified manufacturing firms in Europe and Asia

4. Distributors and Wholesalers

Once produced, sodium oxybate formulations are distributed through a network of licensed pharmaceutical wholesalers. These entities comply with strict regulatory standards to prevent diversion and counterfeiting.

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Global Supply and Availability

Sodium oxybate’s supply chain is geographically concentrated, primarily due to the compound’s controlled status. The United States relies on Jazz Pharmaceuticals’s manufacturing; in Europe, licensing agreements and regional manufacturers provide supply, with ongoing efforts for generic manufacturing under strict regulatory oversight.

In emerging markets, supply depends heavily on licensed imports from established producers. The complexity and regulation of sodium oxybate manufacturing often limit the number of producers, leading to potential supply shortages or price volatility.

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Regulatory Challenges and Supply Chain Risks

Regulatory hurdles, such as licensing, import/export restrictions, and GMP compliance, limit the number of capable suppliers. Additionally:

• Diversion Risk: Strict controls aim to prevent misuse and illegal distribution, complicating supply chain transparency.
• Manufacturing Complexity: Synthesis involves hazardous chemicals and precise control measures, limiting the number of compliant producers.
• Geopolitical Factors: Trade restrictions and licensing delays can impact the availability in certain regions.

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Innovations and Future Supply Considerations

Ongoing research into alternative synthesis methods, more efficient manufacturing processes, and potential generic formulations could diversify and stabilize supply chains in the future. Regulatory agencies’ evolving stance on GHB derivatives may influence market dynamics and supplier entry barriers.

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Key Takeaways

• Market Monopoly by Jazz Pharmaceuticals: Currently, Jazz Pharmaceuticals is the exclusive supplier of pharmaceutical-grade sodium oxybate in many markets, controlling production, quality, and distribution.
• Limited Number of Raw Material Suppliers: High-purity gamma-hydroxybutyric acid is produced by select specialty chemical manufacturers under strict compliance regimes.
• Global Supply Chain Concentration: Supply stability is influenced by geographic and regulatory factors, with Europe and North America being primary markets.
• Regulatory and Security Risks: Strict control is essential to prevent diversion and ensure product safety, which complicates sourcing and increases costs.
• Future Trends: Advances in synthesis and regulatory developments may expand supplier base and improve supply stability.

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FAQs

Q1. Who are the main manufacturers of pharmaceutical-grade sodium oxybate?
Jazz Pharmaceuticals is the primary manufacturer and distributor of pharmaceutical-grade sodium oxybate (Xyrem). No other companies currently hold comparable licensing for finished product manufacturing in major markets.

Q2. Are there generic suppliers of sodium oxybate?
While raw materials like gamma-hydroxybutyric acid are produced by specialty chemical firms, generic pharmaceutical formulations of sodium oxybate are limited due to regulatory and manufacturing complexities. Some regional generic manufacturers are pursuing approval, but market presence remains minimal.

Q3. What are the major regulatory challenges in sourcing sodium oxybate?
Strict DEA scheduling, GMP compliance, licensing for import/export, and security controls create significant hurdles. These regulations limit the number of approved suppliers and enforce rigorous oversight of the supply chain.

Q4. How does the supply chain ensure product safety and prevent diversion?
Through tightly controlled manufacturing practices, licensing requirements, serial tracking, and regulated distribution channels, authorities and manufacturers minimize diversion risks.

Q5. What are future prospects for sodium oxybate supply?
Research into alternative synthesis methods, as well as efforts to establish generic manufacturing, could diversify the supply chain. Regulatory adaptations might facilitate increased manufacturing capacity and lower costs.

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References

1. U.S. Food and Drug Administration (FDA). Xyrem (sodium oxybate) Prescribing Information. 2022.
2. Drug Enforcement Administration (DEA). Drug Scheduling and Regulations. 2023.
3. European Medicines Agency (EMA). Medicines and Regulatory Requirements for Sodium Oxybate. 2023.
4. Jazz Pharmaceuticals. Corporate Information & Manufacturing Processes. 2023.
5. Chemical Suppliers’ Data Sheets. Cayman Chemicals, Toronto Research Chemicals.