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Suppliers and packagers for OXAYDO
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OXAYDO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080 | NDA | Zyla Life Sciences US LLC | 69344-113-11 | 100 TABLET in 1 BOTTLE (69344-113-11) | 2015-09-01 |
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080 | NDA | Zyla Life Sciences US LLC | 69344-213-11 | 100 TABLET in 1 BOTTLE (69344-213-11) | 2015-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Oxaydo
Introduction
Oxaydo is a proprietary pharmaceutical product containing oxycodone, an opioid analgesic primarily prescribed for severe pain management. As a controlled substance, its distribution and supply chain are tightly regulated to prevent misuse and diversion. This article profiles the key suppliers involved in the production, distribution, and supply of Oxaydo, considering the complex regulatory environment and market dynamics shaping its availability.
Understanding Oxaydo and Its Market Context
Oxaydo, marketed by Purdue Pharma, features oxycodone in a formulation designed for immediate-release pain relief. Its patent and exclusivity rights impact market entry and supplier competition. As a Schedule II controlled substance under the United States Drug Enforcement Administration (DEA) classification, strict licensing, and monitoring are required for all entities handling the drug [1].
The market for oxycodone-based products like Oxaydo faces increased regulatory oversight amid ongoing efforts to combat opioid misuse, which influence supply chain practices. Major pharmaceutical manufacturers and authorized distributors are therefore the primary legitimate suppliers within legal frameworks.
Key Manufacturers and Original Suppliers
1. Purdue Pharma
Purdue Pharma developed and marketed Oxaydo as part of its portfolio of prescription pain medications. The company is the originator and primary source of Oxaydo, overseeing its manufacturing and distribution to licensed pharmacies and distributors. Purdue maintains manufacturing facilities compliant with Good Manufacturing Practices (GMP) and holds the necessary DEA registrations to produce controlled substances [2].
2. Contract Manufacturing Organizations (CMOs)
In addition to Purdue, some pharmaceutical companies may engage third-party contract manufacturers to produce oxycodone active pharmaceutical ingredients (APIs). These CMOs are often headquartered globally, with facilities in the U.S., Europe, and Asia, providing scalability and cost efficiencies.
Key CMOs involved include companies like Catalent and Patheon, which have large-scale facilities capable of producing controlled substances under strict regulatory oversight [3].
Distribution and Supply Chain Intermediaries
3. Authorized Distributors
The distribution of Oxaydo involves a limited network of DEA-registered distributors authorized to handle Schedule II controlled substances. Major players include:
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Cardinal Health: As one of the largest pharmaceutical distributors globally, Cardinal Health manages a significant portion of controlled substance supply, adhering to DEA regulations and implementing rigorous tracking systems.
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McKesson Corporation: Known for its extensive distribution network, McKesson supplies pharmacies, hospitals, and clinics with controlled substances, including oxycodone products like Oxaydo.
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AmerisourceBergen: Another key player, AmerisourceBergen, ensures compliance with DEA rules, providing secure distribution channels for opioid medications.
These distributors are subject to serialization, real-time tracking, and regular audits to mitigate diversion risks [4].
4. Specialty and Online Pharmacies
Licensed specialty pharmacies often serve as critical supply points for Oxaydo, especially in pain management centers. These pharmacies purchase directly from authorized distributors, maintaining compliance with federal and state regulations.
Online pharmacies operating within the legal framework also supply Oxaydo, but strict verification procedures are enforced to ensure legitimacy and compliance with drug laws [5].
Global Suppliers and API Producers
While Oxaydo is primarily marketed in the U.S., global suppliers play a role in the production of oxycodone raw materials. Notable API producers include:
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Mundipharma, a related entity operating under Purdue's network, supplies oxycodone APIs to various manufacturers.
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Chinese and Indian API manufacturers, such as Zhejiang NHU Company and Sun Pharmaceutical Industries, produce oxycodone APIs supplied internationally, subject to regulatory approvals for export.
The supply chain integrity relies on stringent regulatory oversight, with global authorities like the U.S. FDA, European Medicines Agency (EMA), and respective national agencies monitoring manufacturing practices.
Regulatory and Ethical Considerations
The supply chain's transparency and security are critical to mitigate opioid misuse. The DEA enforces strict controls through:
- Registration and licensing for manufacturers, distributors, and dispensers.
- Tracking systems, such as the Automation of Reports and Consolidated Orders System (ARCOS), which monitor the flow of controlled substances from production to dispensing [6].
- E-prescribing protocols, to reduce diversion risks.
As the opioid crisis persists, regulators continually tighten supply chain oversight, impacting the number and nature of suppliers authorized to handle Oxaydo.
Emerging Trends and Future Outlook
- Supply Chain Consolidation: Recent mergers among distribution giants may streamline or complicate supply channels.
- Alternative Formulations: Development of abuse-deterrent formulations of oxycodone may influence the market dynamics and, consequently, supply chain configurations.
- Regulatory Pressure: Increased scrutiny could limit the number of authorized suppliers or introduce new compliance requirements, impacting overall supply stability.
Conclusion
The supply landscape for Oxaydo hinges on Purdue Pharma as the primary manufacturer, supported by a global network of API producers, DEA-licensed distributors, and licensed pharmacies. Regulatory oversight remains central to ensuring secure and compliant distribution amid ongoing efforts to curb opioid misuse.
Key Takeaways
- Purdue Pharma remains the core supplier of Oxaydo, controlling production and distribution within regulatory bounds.
- Contract manufacturing by global CMOs supports oxycodone API supply, predominantly from Asian manufacturers.
- Major pharmaceutical distributors—Cardinal Health, McKesson, and AmerisourceBergen—manage the bulk of legal Oxaydo distribution.
- Strict DEA regulations, serialization, and real-time tracking confer supply chain integrity and mitigate diversion.
- Future supply chain stability depends on regulatory policies, market demand, and innovations in abuse-deterrent formulations.
FAQs
1. Who are the primary manufacturers of Oxaydo?
Purdue Pharma is the original manufacturer of Oxaydo, overseeing production and distribution. API production may involve third-party contract manufacturers globally.
2. How is the supply of Oxaydo regulated?
Its distribution is heavily regulated under DEA Schedule II controls, with licensing, serialization, real-time tracking, and strict oversight of all involved entities.
3. Can global API producers supply oxycodone for Oxaydo?
Yes, with appropriate regulatory approvals, API producers from China, India, and Europe supply oxycodone to licensed drug manufacturers.
4. What threats exist to the supply chain of Oxaydo?
Potential threats include regulatory tightening, diversion, theft, and manufacturing disruptions, which can impact drug availability.
5. Are online pharmacies legitimate sources for Oxaydo?
Only licensed, verified online pharmacies authorized by DEA or relevant authorities are legitimate sources, adhering to strict legal and safety standards.
References
[1] DEA. (2022). Controlled Substances Act (CSA). U.S. Drug Enforcement Administration.
[2] Purdue Pharma. (2023). Oxaydo Product Information. Purdue Pharma Official Website.
[3] MarketWatch. (2022). Contract manufacturing trends in controlled substances.
[4] FDA. (2021). Drug Supply Chain Security Act (DSCSA). U.S. Food and Drug Administration.
[5] National Association of Boards of Pharmacy. (2023). Online pharmacy verification procedures.
[6] DEA. (2022). ARCOS Report & Data. U.S. Drug Enforcement Administration.
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