calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690	NDA	Jazz Pharmaceuticals, Inc.	68727-150-01	180 mL in 1 BOTTLE, PLASTIC (68727-150-01)	2020-11-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

The pharmaceutical compounds calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate—a class of oxybates—are vital therapeutic agents primarily used for narcolepsy and other sleep disorders. Their production involves complex manufacturing processes, strict regulatory oversight, and sourcing of high-quality raw materials. Identifying reliable suppliers for these compounds is crucial for pharmaceutical manufacturers, distributors, and healthcare providers aiming to ensure drug efficacy, safety, and regulatory compliance.

This report offers a comprehensive overview of suppliers manufacturing and distributing these oxybates, focusing on their market presence, manufacturing capabilities, supply reliability, and regulatory standing.

Understanding the Drugs

Chemical Nature and Uses

Oxybates are central nervous system depressants, acting on gamma-aminobutyric acid (GABA) receptors to promote sleep and reduce cataplexy. The sodium salt, sodium oxybate, is the most widely marketed and FDA-approved, marketed under the brand Xyrem by Jazz Pharmaceuticals. Other oxybates, such as calcium oxybate, magnesium oxybate, and potassium oxybate, are primarily used in research or as alternative formulations, with limited commercial manufacturing and distribution.

Regulatory Status

Sodium oxybate (Xyrem) has an approved NDA in the United States and similar approvals worldwide. The other oxybates often exist in research settings or are produced under strict regulatory controls due to their potential for abuse and central nervous system effects.

Major Suppliers and Manufacturers

1. Jazz Pharmaceuticals (Xyrem - Sodium Oxybate)

Market Leader and Official Manufacturer
Jazz Pharmaceuticals holds the majority of the market for sodium oxybate through its proprietary manufacturing process and regulatory approval. The company manufactures Xyrem using its patented processes and ensures supply through a vertically integrated model encompassing raw material sourcing, manufacturing, and distribution.

Production Capabilities:

Fully compliant with FDA Good Manufacturing Practices (GMP).
Advanced production facilities dedicated to maintaining product purity and consistent quality.
Strict control over raw material procurement, with global sourcing of pharmaceutical-grade sodium salts.

Supply Chain:

Managed through a robust global logistics network, ensuring steady supply to North America, Europe, and other markets.
Acts as the sole legal supplier in certain markets, enforced through patent rights and regulatory exclusivity.

2. Chinese Manufacturers

Emerging Suppliers in Raw Material Market
China remains a significant hub for bulk chemical manufacturing, including oxybates' raw materials like sodium hydroxide and sodium salts, which are precursors for oxybate production.

Jiangsu Hualun Pharmaceutical Co., Ltd.: Specializes in raw pharmaceutical chemicals, including sodium compounds used in oxybate synthesis.
Shandong Xinhua Pharmaceutical: Produces pharmaceutical intermediate chemicals potentially used in oxybates' manufacturing.

Limitations:

These suppliers generally do not manufacture finished oxybate drugs but provide pharmaceutical-grade raw materials under strict quality agreements.
Supply reliability can vary due to regulatory scrutiny, quality standards, and export restrictions.

3. Indian Suppliers

Active Pharmaceutical Ingredient (API) Producers
India features several reputed API manufacturers capable of synthesizing oxybates or their precursors under GMP conditions.

Lupin Limited and Sun Pharmaceutical Industries: Known for producing a broad spectrum of pharmaceuticals; some possess the capacity for oxybates' derivatives.
Gujarat State Chemical Industries (GSC): Produces sodium salts for various pharmaceutical applications.

Status:

These companies are primarily focused on APIs for domestic and export markets.
Their capacity to produce oxybates is often constrained by regulatory approvals and patent licensing.

4. European Suppliers

Focus on Raw Materials and Intermediates
European chemical manufacturers supply high-quality intermediates used in oxybate synthesis.

Evonik Industries: Provides specialty chemicals suitable for pharmaceutical manufacturing, including sodium compounds.
BASF: Engages in custom chemical synthesis and provides pharmaceutical-grade raw materials for oxybates.

Regulatory Considerations:

Stringent compliance with EMA regulations allows for high-quality raw materials but limits direct manufacturing of oxybates by these companies.

5. Specialized Contract Manufacturers and Custom Synthesis Experts

Certain firms offer custom synthesis of oxybates or related compounds under strict confidentiality and GMP standards.

Ampacet Corporation and Bachem AG: Although primarily known for peptide synthesis, some also provide custom chemical synthesis services, including specialized intermediates or formulations.

Features:

These firms often operate under confidential agreements, providing tailored solutions for pharmaceutical development and manufacturing.

Key Factors Influencing Supplier Selection

Regulatory Compliance & Quality Assurance

Suppliers must adhere to global GMP standards, with certifications from agencies like the FDA, EMA, or PMDA, ensuring compliance with quality, safety, and purity specifications.

Supply Reliability & Capacity

Given the critical nature of oxybates, reliable supply chains with redundancy and contingency plans are essential, especially when considering raw material sourcing or manufacturing capacity constraints.

Pricing & Cost-Effectiveness

While high-quality standards are non-negotiable, competitive pricing plays an integral role, particularly for mid- to late-stage pharmaceutical companies seeking cost efficiencies.

Intellectual Property & Licensing Agreements

Suppliers operating under licensing agreements with patent holders like Jazz Pharmaceuticals may be limited in their ability to produce or supply certain oxybates globally.

Emerging Trends and Challenges

Regulatory Constraints on Raw Materials: Increasing legislation regarding controlled substances affect the sourcing and distribution of oxybates and their precursors.
Shift Towards Alternative Delivery Forms: Development of non-scheduled formulations may impact supplier dynamics.
Global Supply Chain Disruptions: COVID-19 pandemic underscored vulnerabilities in supply chains, necessitating diversified sourcing strategies.

Conclusion

The primary supplier for proprietary oxybates—sodium oxybate—is Jazz Pharmaceuticals, which maintains direct control over manufacturing and distribution, backed by robust regulatory compliance. For raw materials and intermediates, Chinese, Indian, and European chemical companies dominate, providing high-quality pharmaceutical-grade chemicals essential for oxybates' synthesis.

Manufacturers aiming to source these compounds must prioritize suppliers with proven GMP standards, reliable supply chains, and compliance with evolving legal frameworks, especially considering the controlled substance status of these drugs. As the market and regulatory environment evolve, diversification of supplier bases, investment in quality assurance, and collaboration with licensed manufacturers will be vital for uninterrupted supply and regulatory compliance.

Key Takeaways

Jazz Pharmaceuticals is the principal manufacturer and distributor of sodium oxybate (Xyrem), holding patents and regulatory exclusivity in key markets.
Raw materials for oxybates are supplied predominantly by Chinese, Indian, and European chemical companies, with strict quality controls.
Regulatory compliance and supply reliability are paramount, given the drugs' status as controlled substances and their medical importance.
Emerging risks, including regulatory limitations and supply chain disruptions, necessitate strategic sourcing and diversified supplier relationships.
Future landscape may see increased development of alternative formulations, shifting the supplier and manufacturing paradigms.

FAQs

1. Who are the major manufacturers of sodium oxybate (Xyrem)?

Jazz Pharmaceuticals is the sole legally authorized manufacturer of Xyrem in major markets, maintaining proprietary manufacturing processes and regulatory protections.

2. Can pharmaceutical companies source oxybates from Chinese or Indian suppliers?

Yes, primarily raw materials and intermediates are sourced from Chinese and Indian suppliers under strict quality and regulatory agreements, but final oxybates are generally produced by licensed entities like Jazz Pharmaceuticals.

3. What are the primary challenges in sourcing oxybates?

Challenges include regulatory strictures on controlled substances, supply chain disruptions, quality assurance requirements, and patent/license constraints.

4. Are there any alternative suppliers for calcium, magnesium, or potassium oxybate?

While raw materials can be sourced from chemical suppliers globally, finished oxybates are typically manufactured by licensed pharmaceutical companies; alternative formulations are limited due to regulatory and patent restrictions.

5. How do regulatory agencies influence oxybate supply chains?

Agencies like the FDA and EMA enforce stringent controls, requiring manufacturers to comply with GMP, limit distribution to licensed entities, and monitor supply chains to prevent diversion or misuse.

References

[1] Jazz Pharmaceuticals. (2022). Xyrem (sodium oxybate) prescribing information.
[2] European Medicines Agency. (2023). Regulatory framework for controlled substances.
[3] U.S. Food and Drug Administration. (2023). Schedule of controlled substances.
[4] Global Chemical Suppliers Directory. (2023). Pharmaceutical chemicals sourced from China, India, and Europe.

Suppliers and packagers for generic pharmaceutical drug: calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate