CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE: Pharmaceutical manufacturers, suppliers, and packagers

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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: May 31, 2026

Suppliers for Calcium Oxybate, Magnesium Oxybate, Potassium Oxybate, and Sodium Oxybate (API and Salt Raw Materials)

The oxybate-salt supply chain is dominated by chemical intermediates (oxybutyric acid/related precursors) and by firms that can consistently produce food-grade, pharmaceutical-grade salts under controlled specs. Downstream suppliers typically sell (i) active pharmaceutical ingredient (API) salts of oxybutyric acid (calcium, magnesium, potassium, sodium), (ii) oxybutyric acid intermediates used to manufacture the salts, and (iii) packaging and analytical release support for regulated batch release.

Who are the key suppliers of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate?

Featured-snippet answer: Suppliers tend to be split between (1) API manufacturers producing the oxybate salts under cGMP and (2) chemical manufacturers supplying oxybutyric acid or salt-making precursors that are converted into the final oxybate forms by contract manufacturers.

What supplier categories exist for oxybate salts?

API manufacturers selling finished oxybate salts (calcium/magnesium/potassium/sodium).
Contract manufacturing organizations (CMOs) that synthesize oxybutyric acid salts from intermediates for branded-label and generic customers.
Chemical ingredient producers supplying oxybutyric acid or upstream intermediates, then licensing conversion steps to salt-formulation partners.
Specialty logistics and quality partners supporting stability, impurity profiling, and regulatory documentation for salts.

What distinguishes supply for oxybate salts versus oxybate esters?

Oxybate salts are handled as inorganic-organic blends with tight control of:

Water content and residual solvents (often reduced but not eliminated).
Counterion stoichiometry (Ca/Mg/K/Na equivalence).
Impurity profiles, including residual starting acids, halogenated or dehydrating byproducts (depending on route), and elemental impurities for ingestibles.

Which companies supply oxybutyric acid intermediates used to make oxybate salts?

Oxybate salts for calcium, magnesium, potassium, and sodium forms are commonly manufactured from oxybutyric acid (or closely related oxybutyric acid derivatives) plus the appropriate base/counterion source, followed by crystallization and polishing.

Supplier landscape for oxybutyric acid inputs

Supply for oxybutyric acid inputs typically comes from:

Commodity chemical producers who can provide pharmaceutical-grade or reagent-grade material under documented specs.
Organic fine-chemical firms with defined impurity control, GC/HPLC batch release, and trace metals control.

Why counterion-specific supply matters

Even when the same upstream oxybutyric acid is used, salt conversion changes:

Solubility, crystallinity, and bulk density.
Hygroscopicity and shelf-life sensitivity to humidity.
Filtration and drying profiles, which affect impurity formation and water activity.

What cGMP API manufacturers can supply calcium oxybate and magnesium oxybate?

Calcium and magnesium oxybate supply is usually more constrained because:

Divalent salts often show higher sensitivity to hydration state.
Consistent crystallization performance drives batch-to-batch reproducibility.

Common manufacturing controls for Ca/Mg oxybates

Controlled crystallization temperature and seeding strategy.
Drying endpoint monitoring (Karl Fischer or equivalent).
Particle size distribution control for compressibility or filling performance.

Which suppliers handle potassium oxybate and sodium oxybate at scale?

Monovalent salts (potassium and sodium oxybates) often have broader supplier options because:

Salt formation routes can be more straightforward.
Crystallization and drying can be easier to control relative to divalent salts.

Typical QA release targets

Assay by validated HPLC titration or equivalent method.
Water content window.
Specific impurity thresholds aligned to pharmacopeia and internal specifications.
Residual inorganic ions (Ca/Mg/K/Na carryover) consistent with salt identity.

How do suppliers vary by dosage form and packaging requirements for oxybate salts?

Oxybate salts are commonly sold for:

Oral solution or oral powder reconstitution.
Solid dose formulations (depending on product strategy).

Packaging constraints

High-humidity protection for hygroscopic salts.
Nitrogen blanketing and desiccant integration for multi-dose packaging.
Stability programs at ICH conditions with humidity stress.

Analytical documentation differences

Salt identity and polymorph/crystal form documentation.
Moisture and conductivity specs that reflect counterion content and hydration.

What supply constraints and risks affect oxybate-salt sourcing?

Key risks in oxybate-salt procurement include:

Batch release failure tied to moisture content variability.
Supply interruptions from intermediate feedstock availability.
Regulatory document readiness delays (DMFs, CoC structures, GMP certificates).
Capacity constraints in crystallization and drying steps.

Operational bottlenecks

Crystallizer and centrifuge time for divalent salts.
Oven capacity for moisture-sensitive materials.
Quality lab throughput for impurity profiling.

How can buyers qualify oxybate-salt suppliers for regulatory and commercial use?

Qualification usually includes:

cGMP manufacturing evidence for API salt production.
Written impurity profile comparability and change control history.
Batch data review including CoA, CoC, and method validation summaries.
Stability data package acceptance and photostability/humidity testing.

What buyers require in supplier documentation

GMP certificate (or equivalent compliance statement).
Regulatory submission support: DMF availability or suitability for referenced submissions.
Viral and adventitious agent controls if required by the downstream process (more relevant if any biological steps exist; less common for chemical APIs).

Supplier due-diligence checklist specific to calcium/magnesium/potassium/sodium oxybate

Confirm salt identity method (e.g., counterion determination).
Confirm water content specification and test method.
Confirm impurity profile and thresholds for each salt identity.
Confirm crystallization control records and batch uniformity metrics.
Confirm stability program parameters: temperature, humidity, package type.
Confirm shipping protection and shelf-life labeling based on real-world humidity exposure.

How does procurement pricing typically behave for oxybate salts?

Pricing for oxybate salts often tracks:

Upstream oxybutyric acid feedstock cost.
Counterion reagent price and availability.
Yield losses in crystallization for divalent salts.
Lab and documentation cost for compliant API release.

What drives margin compression

Rejected lots due to moisture or assay drift.
Rework due to crystallization failure.
Increased analytical spend as impurity limits tighten for market entries.

Key Takeaways

Oxybate salts (calcium, magnesium, potassium, sodium) are supplied via a mix of cGMP API manufacturers and intermediate-based CMO conversions from oxybutyric acid.
Supplier qualification hinges on salt identity (counterion stoichiometry), water content control, impurity profiling, and stability under humidity.
Divalent salts (calcium, magnesium) face tighter process sensitivity around crystallization and hydration state, increasing supply risk versus monovalent salts (potassium, sodium).
Procurement risk concentrates in batch release variability and upstream intermediate availability, not only in final API packaging.

FAQs

How do I verify whether calcium oxybate vs sodium oxybate is correctly specified by suppliers?
What analytical methods are typically used to control water content in oxybate salts?
What manufacturing steps most affect impurity formation in divalent oxybate salts?
Which documentation items are most critical for regulatory submissions of oxybate APIs?
What humidity-related stability failure modes are common for potassium and sodium oxybate salts?

References

No sources provided in the prompt.

Suppliers and packagers for generic pharmaceutical drug: CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE