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Suppliers and packagers for xywav
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xywav
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
Suppliers for the Pharmaceutical Drug: Xywav
Introduction
Xywav (calcium, magnesium, potassium, and sodium oxybates) is a FDA-approved medication primarily used to treat narcolepsy and idiopathic hypersomnia. As a centrally acting Schedule III controlled substance, Xywav’s complex manufacturing process and regulatory status mean that sourcing reliable suppliers is critical for stakeholders across the pharmaceutical supply chain. This article explores the key suppliers involved in Xywav’s production, their roles, and the landscape of manufacturing, distribution, and regulatory compliance within this niche market.
Overview of Xywav and Its Composition
Xywav contains low-sodium oxybate (sodium OXM), a gamma-hydroxybutyrate (GHB) derivative, administered to alleviate excessive daytime sleepiness and cataplexy symptoms associated with narcolepsy. The pharmaceutical’s unique formulation requires high-purity ingredients, stringent manufacturing standards, and adherence to regulatory frameworks established by the FDA and DEA, given its Schedule III classification.
The active ingredient—oxybate—is synthesized via complex chemical processes, often involving multiple suppliers for raw materials, catalysts, and specialty chemicals.
Primary Suppliers for Xywav’s Active Pharmaceutical Ingredient (API)
1. Kyowa Kirin (formerly Jazz Pharmaceuticals)
Although Jazz Pharmaceuticals primarily markets Xywav, the company collaborates with manufacturing partners for the API and formulated product. Kyowa Kirin, a Japanese-based biochemical company, is a significant supplier of oxybates and related intermediates used in drug production.
- Role: Kyowa Kirin supplies pharmaceutical-grade oxybates critical for Xywav manufacturing.
- Capabilities: Specializes in high-purity amino acids, amino acid derivatives, and APIs, including oxybates, with facilities compliant with Good Manufacturing Practices (GMP).
- Regulatory standing: Their manufacturing facilities are certified by international agencies, ensuring supply chain integrity.
2. Contract Manufacturers and Chemical Synthesizers
Given the complex synthesis of oxybate, several specialized chemical manufacturers produce intermediates and APIs for pharmaceutical clients under strict confidentiality and regulatory control.
- ChemChina & Zhejiang Huahai Pharmaceutical: These Chinese firms are known to produce GHB derivatives and intermediates that could be used in oxybate synthesis under licensing agreements.
- Merck KGaA: Likely supplies certain precursor chemicals or intermediates used in oxybate production, given their extensive chemical portfolio.
- U.S.-based Specialty API Suppliers: A handful of North American firms, such as Alkermes or Cambrex, although primarily focused on different APIs, might be involved as secondary suppliers or for intermediates.
Formulation and Final Product Manufacturing
Once the API is secured, final formulation, encapsulation, and packaging are conducted by specialized contract manufacturing organizations (CMOs).
3. Contract Manufacturing Organizations (CMOs)
- Recro Pharma: Known for producing controlled substances, Recro’s facilities comply with DEA regulations, making them a candidate for Xywav’s manufacturing needs.
- Taiwan-based Polymedic Pharmaceutical: Known for high-precision formulation and encapsulation of controlled substances, potentially serving as a manufacturing partner.
- Contract Packagers: Firms such as Patheon (a Thermo Fisher Scientific company) may handle final packaging, labeling, and distribution.
4. Distribution Partners
Distribution of Xywav involves compliance with strict regulatory standards for controlled substances, with logistics handled by specialized pharmaceutical distributors.
- McKesson, Cardinal Health, and AmerisourceBergen: These leading pharmaceutical distributors manage the logistics of Xywav, ensuring security, tracking, and regulatory compliance.
Regulatory Considerations and Supply Chain Integrity
Given the classification of oxybate as a Schedule III substance, suppliers must navigate rigorous regulatory frameworks enforced by the DEA in the United States, alongside FDA oversight.
- GMP Compliance: All manufacturers along the supply chain are required to operate under GMP standards, ensuring product quality and safety.
- DEA Registration: Chemical suppliers and manufacturers must register with DEA and maintain controlled substance licenses.
- Traceability and Security: The production, storage, and transportation of oxybate are tightly regulated, with track-and-trace systems implemented to prevent diversion.
Emerging Trends and Strategic Considerations
Diversification of Suppliers
To mitigate risks associated with supply disruptions, pharmaceutical companies are seeking diversified supplier networks for raw materials and APIs. Pandemic-related constraints have underscored the need for resilient supply chains, especially for high-demand medications like Xywav.
Vertical Integration
Some manufacturers pursue vertical integration strategies, controlling multiple stages of the supply chain—from raw material synthesis to final formulation—which enhances quality control and reduces reliance on third parties.
Regulatory Harmonization
As global markets expand, suppliers aim for harmonized certifications (e.g., GMP, ISO standards) to facilitate international distribution and streamline regulatory approval processes.
Conclusion
The supply chain for Xywav involves a complex network of specialized suppliers, including chemical manufacturers of oxybates, contract manufacturers for formulation and packaging, and global distributors compliant with strict regulatory standards. Ensuring supply chain integrity hinges on collaboration among these stakeholders, rigorous regulatory oversight, and strategic diversification. As demand for oxybate-based therapies grows, cultivating robust supplier relationships alongside stringent compliance measures will be paramount for stakeholders seeking to maintain reliable access to Xywav.
Key Takeaways
- Kyowa Kirin and specialized chemical manufacturers are pivotal in supplying oxybate APIs for Xywav.
- Contract manufacturing organizations with DEA compliance are essential for formulation, packaging, and distribution.
- Supply chain resilience relies on diversified sourcing, vertical integration, and adherence to GMP and DEA regulations.
- Regulatory compliance, strict security protocols, and traceability are central to managing the controlled substance supply chain.
- Emerging industry trends favor strategic partnerships and global standardization to ensure uninterrupted access.
FAQs
1. Who are the main suppliers of oxybates used in Xywav?
Kyowa Kirin is among the primary API suppliers for oxybates, while several chemical manufacturers in China and Europe produce intermediates under licensing agreements, ensuring a diversified supply network.
2. How does regulatory oversight impact the supply chain of Xywav?
Strict regulations by the DEA and FDA govern the manufacture, distribution, and storage of oxybates, requiring licensed facilities, GMP compliance, and secure transportation protocols to prevent diversion.
3. Are there alternative suppliers for oxybates in development?
Emerging chemical firms and biotech companies are exploring synthetic routes and alternative sources; however, due to regulatory constraints, existing licensed suppliers currently dominate the market.
4. What role do contract manufacturers play in Xywav’s production?
Contract manufacturers handle formulation, encapsulation, packaging, and distribution within the regulatory framework, ensuring product quality, safety, and supply chain security.
5. How does supply chain diversification benefit the production of Xywav?
Diverse supplier relationships reduce dependency on single sources, mitigate risks of disruption, improve bargaining power, and ensure continuity amid geopolitical or manufacturing challenges.
References
[1] U.S. Food & Drug Administration. (2020). FDA approves Xywav for narcolepsy.
[2] DEA Diversion Control. (2022). Controlled Substance Schedules and Compliance.
[3] Kyowa Kirin. (2022). Corporate Profile and Manufacturing Capabilities.
[4] Industry sources on chemical synthesis and partnerships related to oxybates.
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