How to Source Sodium oxybate for Pharmaceutical Formulation
Sodium oxybate (Oral Solution, 500 mg/ml) is classified under Neurology. It is therapeutically aligned with reference brands such as Xyrem (USA/EU), Lumryz (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Sodium oxybate for formulation, R&D, or bulk manufacturing.
Product Overview:
Sodium oxybate is used to treat symptoms of Narcolepsy — particularly excessive daytime sleepiness and episodes of sudden muscle weakness (cataplexy). It acts as a central nervous system depressant, promoting deep sleep at night, which helps reduce daytime sleepiness and improve overall sleep‑wake regulation.
1. Regulatory Compliance & Documentation
Ensure suppliers provide:
- ✔ Valid DMF (Drug Master File)
- ✔ COA (Certificate of Analysis) for each batch
- ✔ GMP, ISO, or ICH Q7 compliance certificates
2. Purity, Grade & Specification Matching
Sodium oxybate must meet exact grade and purity for your dosage form:
- ✔ USP / EP / JP grade verification
- ✔ Particle size distribution check
- ✔ Residual solvent and heavy metal limits
3. Supplier Reliability & Audit History
- ✔ Positive past audit reports
- ✔ Pharma client references
- ✔ Years of proven API manufacturing experience
4. Commercial Terms: Pricing, MOQ & Flexibility
- ✔ Transparent pricing
- ✔ Pilot batch MOQ flexibility
- ✔ Volume-based discounts
5. Lead Time, Inventory & Logistics
Typical lead time for Sodium oxybate is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Conclusion
Sourcing Sodium oxybate is more than procurement—it’s a strategic partnership. With its oral solution form and 500 mg/ml specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.
Next Step: Get expert assistance in sourcing Sodium oxybate.
Frequently Asked Questions For Sourcing of Sodium oxybate
What is the typical lead time for Sodium oxybate?
Lead times range from 4–6 weeks depending on supplier and region.
Is Sodium oxybate available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Sodium oxybate require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Sodium oxybate?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Sodium oxybate?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Sodium oxybate?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Sodium oxybate suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Sodium oxybate be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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