Bulk Pharmaceutical API Sources for ARYMO ER

Bulk Pharmaceutical API Sources for ARYMO ER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M9524_SIAL
BenchChem		B1236521
CymitQuimica		CQ_64-31-3
RR Scientific		R4090453
RR Scientific		R6225553
EvitaChem		evt-1570083

Bulk Active Pharmaceutical Ingredient (API) Sources for ARYMO ER

Last updated: July 28, 2025

Introduction

ARYMO ER (oxycodone extended-release) is a prescription opioid formulation used predominantly for managing severe pain requiring around-the-clock relief. As a controlled substance, its manufacturing hinges on high-quality Active Pharmaceutical Ingredients (APIs) that meet stringent regulatory standards for purity, potency, and consistency. Identifying reliable bulk API sources is critical for pharmaceutical companies to ensure supply chain integrity, regulatory compliance, and product efficacy.

This comprehensive analysis evaluates key API sourcing options for oxycodone, the active ingredient in ARYMO ER, emphasizing global suppliers, quality assurance measures, and strategic considerations for pharmaceutical manufacturers.

Overview of Oxycodone API

Oxycodone hydrochloride is a semi-synthetic opioid derived from thebaine, a natural alkaloid found in the opium poppy. The synthesis involves multiple chemical steps from natural precursors, necessitating rigorous control over raw materials and manufacturing conditions to maintain consistent API quality.

The API must adhere to the standards set by the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other relevant pharmacopeias, ensuring compliance with purity criteria, residual solvent limits, residual catalysts, and assessment of contaminants.

Global API Manufacturers for Oxycodone

1. Major Pharmaceutical Contract Manufacturing Organizations (CMOs) and Tradtional API Producers

a. Zhejiang NHU Co., Ltd. (China)

• Overview: Zhejiang NHU is among China’s leading producers of APIs, including opioids like oxycodone.
• Compliance: Certified cGMP facilities with international regulatory approvals, including FDA and EMA.
• Strengths: Cost-effective manufacturing scale, proven track record in opioid APIs, robust quality assurance, and extensive experience with stringent regulatory standards.
• Considerations: Potential geopolitical and supply chain risks associated with regional disruptions.

b. CP Pharmaceuticals (United Kingdom)

• Overview: Specializes in high-volume production of opioids, including oxycodone API, with an emphasis on compliance and quality.
• Compliance: GMP certification and extensive regulatory history with the MHRA and FDA.
• Strengths: Proven regulatory track record, high-quality standards, reliable supply.

c. Sun Pharmaceutical Industries Ltd. (India)

• Overview: One of the largest pharmaceutical companies globally, producing a broad spectrum of APIs, including opioids.
• Compliance: GMP-certified facilities aligned with international standards.
• Strengths: Cost advantages, established supply channels, and high-quality control systems.

d. Pfizer (United States & Global Manufacturing Sites)

• Overview: Historically involved in opioid API production, though some manufacturing assets have been divested.
• Current Status: Limited to specific markets or partnered manufacturing arrangements.
• Strengths: Regulatory assurance, extensive pharmaceutic expertise.

2. Specialized Opioid API Suppliers

a. Zhejiang Kangle Pharmaceutical Co., Ltd. (China)

• Focuses on opioid APIs, including oxycodone, with rigorous quality controls and compliance with international standards.

b. Zhejiang Xianju Pharmaceutical Co., Ltd. (China)

• A growing API producer with a focus on narcotic APIs, including oxycodone, attuned to international regulatory requirements.

c. Daito Pharmaceutical Co., Ltd. (Japan)

• Known for high-quality API manufacturing with strict quality controls and regulatory compliance, serving global markets.

3. South American and European API Producers

While less prominent in opioid API manufacturing, certain European and South American API suppliers offer oxycodone with high regulatory standards, often catering to regional markets or certified export channels.

• Sterling Pharma Solutions (UK): Offers niche opioid APIs with high purity standards.
• Polpharma (Poland): Engages in large-scale API manufacturing with compliant facilities.

Key Factors Influencing API Sourcing Decisions

Quality and Regulatory Compliance

Ensuring API suppliers meet cGMP, FDA, EMA, and other relevant standards is imperative. Oral, analytical, and process validation data must match the strict specifications required for controlled substances like oxycodone. Supplierscertified by Good Manufacturing Practice (GMP) audits are preferred.

Supply Chain Security

Reliable, diversified supply chains mitigate risks related to geopolitical issues, raw material shortages, or transportation disruptions. Regional suppliers in North America, Europe, and Asia can support supply chain resilience.

Raw Material Traceability

Suppliers must demonstrate strict control over the origin of raw materials, including thebaine or precursor chemicals, ensuring supply chain transparency and compliance with import/export regulations.

Pricing and Capacity

Cost considerations are balanced against quality and regulatory compliance. Large-scale manufacturers often provide economies of scale, but smaller, specialized firms may offer flexibility and innovation.

Intellectual Property and Licensing

Some suppliers operate under licensing agreements with patent holders, ensuring legal manufacturing and sale of oxycodone API. Licensing agreements impact supply agreements and market access.

Regulatory and Compliance Considerations

Manufacturers sourcing oxycodone API must ensure supplier adherence to regulatory standards governing controlled substances, including strict recordkeeping, auditing, and reporting protocols. Import/export licenses for narcotics, DEA registration (for U.S. manufacturers), and compliance with international narcotic control treaties are mandatory.

The API's quality profile, including detailed Certificates of Analysis (CoA), residual solvent testing, heavy metal testing, and microbiological controls, underpins regulatory approval processes.

Strategic Sourcing Recommendations

For pharmaceutical companies developing or manufacturing ARYMO ER, establishing multiple API supply sources offers risk mitigation and competitive advantage. Engaging with suppliers who demonstrate transparent quality systems, regulatory integrity, and scalable capacity is key. Collaborative quality agreements, periodic audits, and continuous process validation are essential pillars of successful API procurement.

Furthermore, considering near-sourcing options accommodates regulatory changes, geopolitical uncertainties, and local market demands, especially within North America and Europe.

Conclusion

Securing high-quality bulk oxycodone API sources is fundamental to maintaining the therapeutic efficacy, safety, and regulatory compliance of ARYMO ER. Leading global producers, primarily based in China, India, and Europe, offer mature manufacturing capabilities aligned with international standards. The choice of supplier should prioritize quality assurance, supply chain resilience, compliance history, and cost-effectiveness.

By cultivating strategic partnerships with vetted API manufacturers and maintaining rigorous quality oversight, pharmaceutical companies can ensure consistent supply of oxycodone API, thereby supporting uninterrupted production of ARYMO ER and safeguarding patient care.

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Key Takeaways

• Reliable API sourcing for ARYMO ER hinges on partnerships with GMP-certified producers with proven regulatory compliance.
• Major sources include Zhejiang NHU (China), CP Pharmaceuticals (UK), and Sun Pharmaceutical (India), offering scalable, high-quality oxycodone APIs.
• Diversifying suppliers mitigates risks arising from geopolitical or regional disruptions, ensuring supply chain resilience.
• Strict adherence to regulatory standards and raw material traceability upholds product quality and compliance.
• Strategic API sourcing supports sustainable production, regulatory approval, and market competitiveness.

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FAQs

1. What are the primary considerations when sourcing oxycodone API for ARYMO ER?
Quality assurance, regulatory compliance, supply chain reliability, raw material traceability, and cost are the primary factors. Ensuring suppliers meet GMP standards and possess necessary narcotic licenses is essential.

2. Which regions dominate the production of oxycodone API?
China, India, and Europe host the leading API manufacturers, with China being the largest supplier due to cost advantages and manufacturing capacity.

3. How do regulatory standards impact API sourcing for controlled substances?
Manufacturers must adhere to strict regulations governing narcotics, including certifications, import/export authorizations, and comprehensive documentation, to ensure legal compliance and product safety.

4. Can synthetic modifications influence API sourcing decisions?
Yes. Variations in synthesis pathways, impurity profiles, and process controls can affect API quality, influencing supplier selection and qualification processes.

5. What strategies help mitigate risks in API supply chains?
Diversification of suppliers, regional sourcing, maintaining safety stock, conducting regular audits, and establishing long-term partnerships foster supply chain stability.

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References

[1] U.S. Pharmacopeia, "Oxycodone Hydrochloride," USP Monograph.
[2] European Pharmacopoeia, "Oxycodone Hydrochloride."
[3] Smith, J., et al., "Global API Manufacturing and Supply Chain Insights," Pharmaceutical Technology, 2022.
[4] DEA, "Controlled Substances Regulations," 2023.