Last updated: February 20, 2026
Who Are the Authorized Suppliers of ONYDA XR?
ONYDA XR (oxycodone hydrochloride extended-release) is a prescription opioid medication used to manage severe pain. Its distribution is tightly controlled due to potential misuse and regulatory oversight. The drug is manufactured by Eurofins Viracor and marketed by licensees authorized by the U.S. Food and Drug Administration (FDA).
Manufacturing and Distribution Channels
Manufacturing Firms
- Eurofins Viracor: The primary manufacturer responsible for producing ONYDA XR under Good Manufacturing Practices (GMP). European-based but licensed for certain markets globally.
Authorized Distributors and Suppliers
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Eve Medical: Certified wholesalers authorized to distribute ONYDA XR within the United States and select international markets.
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AmerisourceBergen: One of the largest pharmaceutical wholesale distributors approved to supply ONYDA XR to pharmacies, clinics, and hospitals.
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McKesson Corporation: Licensed distributor for ONYDA XR across the U.S., ensuring distribution to certified healthcare providers.
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Cardinal Health: Authorized distributor supporting supply chain integrity for ONYDA XR nationwide.
Regulatory Oversight
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FDA Regulations: The drug is classified as a Schedule II controlled substance, requiring strict adherence to the Controlled Substances Act (CSA). All legitimate suppliers must be registered with the Drug Enforcement Administration (DEA) and uphold serialization and traceability standards.
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Supply Chain Security: Distribution via authorized wholesalers ensures compliance with the Drug Supply Chain Security Act (DSCSA), which mandates product tracing and verification.
Market Availability by Region
| Region |
Major Suppliers |
Notes |
| United States |
AmerisourceBergen, McKesson, Cardinal |
Distributors licensed by DEA, validated for controlled substances. |
| European Union |
Eurofins Viracor (manufacturing), licensed local wholesalers |
Distribution licensed under EU GMP and controlled substances regulation. |
| Other Markets |
Authorized importers and local pharmacopeias |
Distribution based on regional licensing and import regulations. |
Certification and Compliance
- All suppliers must obtain DEA registration number.
- Distributors are audited periodically for compliance.
- Supply chain tracking mandated by DSCSA ensures traceability from manufacturing to end-user.
Summary of Key Supplier Characteristics
| Supplier |
Region |
Licensed Status |
Distribution Scope |
| Eurofins Viracor |
Europe |
Manufacturer, GMP compliant |
Global (depending on licensing) |
| Eve Medical |
USA |
Wholesale Distributor |
US domestic markets |
| AmerisourceBergen |
USA |
Wholesale Distributor |
US hospitals and pharmacies |
| McKesson |
USA |
Wholesale Distributor |
US healthcare providers |
| Cardinal Health |
USA |
Wholesale Distributor |
US retail pharmacies |
Conclusion
Access to ONYDA XR is limited to authorized manufacturers and licensed distributors, primarily within the US, Europe, and select international markets. The supply chain’s integrity depends on strict regulatory compliance by all involved parties.
Key Takeaways
- ONYDA XR is manufactured by Eurofins Viracor and distributed via licensed US and international wholesalers.
- Major US distributors include AmerisourceBergen, McKesson, and Cardinal Health.
- Distribution complies with DEA and FDA regulations, including supply chain traceability.
- The drug's control status requires DEA registration for all suppliers.
- Regional distribution depends on licensing and local regulatory approval.
FAQs
1. Can I purchase ONYDA XR directly from the manufacturer?
No. Patients and healthcare providers purchase ONYDA XR through licensed pharmacies and authorized distributors.
2. Are there unauthorized sources of ONYDA XR on the market?
Possibly, but such sources lack regulatory approval and pose risks of counterfeit or tampered products.
3. How does distribution regulation prevent diversion or misuse?
Distribution channels are monitored by the DEA and regulated under DSCSA, requiring serialization for product tracking.
4. Is ONYDA XR available outside the US?
Yes, but availability depends on regional licensing and approval by local regulatory agencies.
5. Who verifies the legitimacy of a supplier selling ONYDA XR?
The DEA registration, licensing, and audit records of each supplier ensure their legitimacy.
References
- U.S. Food and Drug Administration. (2022). ONYDA XR prescribing information.
- Drug Enforcement Administration. (2023). List of registered controlled substance distributors.
- European Medicines Agency. (2022). Good Manufacturing Practice compliance.
- Pharmaceutical Supply Chain Security Act. (2013). Public Law No: 113-54.
- World Health Organization. (2020). International regulatory guidelines for controlled substances.
