Bulk Pharmaceutical API Sources for OXAYDO

Bulk Pharmaceutical API Sources for OXAYDO

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS024457896
Sigma-Aldrich		1485205_USP
Sigma-Aldrich		O1378_SIAL
Sigma-Aldrich		O2628_SIAL
Sigma-Aldrich		Y0000492_SIAL

Bulk Active Pharmaceutical Ingredient (API) Sources for: OXAYDO

Last updated: July 30, 2025

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Introduction

Oxaydo, marketed as a branded formulation of oxycodone hydrochloride, is a potent opioid analgesic used in pain management. As a Schedule II controlled substance, its API sourcing is governed by strict regulatory standards, emphasizing quality, purity, and compliance. This article examines the landscape of API suppliers for oxycodone hydrochloride used in Oxaydo, highlighting key players, sourcing considerations, and industry trends to inform stakeholders in pharmaceutical manufacturing and distribution.

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Regulatory Framework and Industry Standards

API sourcing for opioids like oxycodone is highly regulated by authorities such as the U.S. Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and comparable entities globally. Manufacturers must ensure their APIs meet stringent Good Manufacturing Practice (GMP) standards, with sources often subjected to rigorous audits and documentation reviews. The supply chain integrity is critical given the potential for diversion and misuse of controlled substances.

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Key Global API Suppliers for Oxycodone Hydrochloride

1. Major Pharmaceutical Manufacturers

a. Indivior and Purdue Pharma

While primarily producers or marketers of oxycodone formulations, these companies often manage in-house or contracted API sourcing through established partnerships.

b. Aston Pharma

A notable provider of oxycodone APIs, Aston Pharma produces pharmaceutical-grade oxycodone hydrochloride with facilities compliant with international GMP standards. Their supply chain is recognized for consistency and regulatory compliance.

c. Granules India

An India-based pharmaceutical manufacturer with a robust portfolio of APIs, including oxycodone hydrochloride. Granules India emphasizes cost-effective production without compromising quality, adhering to global GMP guidelines.

d. Sun Pharma

With manufacturing facilities for narcotic APIs, Sun Pharma supplies oxycodone hydrochloride globally, emphasizing compliance with local and international standards.

2. Contract Manufacturing Organizations (CMOs)

Many global pharmaceutical companies utilize CMOs for API procurement. Top CMOs include:

• Croda International: produces specialty chemicals and APIs, including narcotics, with strict quality protocols.

• Hainan Zhaotai Pharmaceutical Co., Ltd.: an Asian manufacturer known for narcotic APIs, including oxycodone, meeting international GMP standards.

• Northeast Pharma: a Chinese API supplier with GMP-certified facilities, providing oxycodone hydrochloride for export.

3. Raw Material and Precursor Suppliers

The initial raw materials or precursor chemicals, such as thebaine or noroxycodone, are sourced predominantly from:

• Alkaloid producers in India and China: supplying raw materials that are chemically processed into oxycodone.

• Specialty chemical companies: such as Mallinckrodt and Sigma-Aldrich, providing intermediates and precursors compliant with regulatory standards.

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Regional Trends in API Sourcing

North America

Due to stringent regulations and high-quality expectations, North American pharmaceutical companies predominantly rely on domestic API production or trusted international suppliers with substantial regulatory citations.

India and China

India and China emerge as the primary manufacturing hubs for oxycodone API, driven by cost advantages and established chemical manufacturing infrastructure. Indian companies such as Granules India and Sun Pharma have been globally recognized for their compliance and capacity.

European Union

European manufacturers focus on high-purity APIs aligned with strict regulatory scrutiny. While less populous in API production, they export primarily to EU-based formulations.

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Supply Chain Considerations

a. Quality and Compliance

API suppliers must meet cGMP standards and possess necessary regulatory approvals (e.g., FDA, EMA). Supplier audits and batch testing records are critical for verification.

b. Regulatory Approvals and Documentation

Suppliers should submit comprehensive documentation, including Drug Master Files (DMFs), stability data, and Certificates of Analysis (COA), establishing transparency and quality assurance.

c. Reliability and Lead Times

Given the drug’s critical endpoint use, sourcing partnerships should prioritize suppliers with proven supply chain stability and rapid response capabilities.

d. Price and Contract Terms

Cost considerations are balanced with legal and regulatory adherence, with long-term agreements often favored to ensure uninterrupted supply.

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Emerging Trends and Future Outlook

• Geopolitical Factors: Trade tensions and regulatory shifts influence sourcing strategies, prompting diversification away from single-source dependencies.

• Quality Standards: Increasing global harmonization (e.g., ICH Q7 guidelines) ensures consistent API quality across regions.

• Technological Innovation: Improved synthesis methods, such as green chemistry approaches, reduce costs and environmental impact, influencing sourcing options.

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Conclusion

sourcing for Oxaydo involves a complex network of global suppliers adhering to rigorous quality and regulatory standards. Established pharmaceutical manufacturers in North America, India, and China are predominant sources, supported by specialized CMOs and precursor suppliers. Businesses aiming to secure reliable, compliant oxycodone API should prioritize long-term partnerships with reputable suppliers, emphasizing regulatory compliance, supply chain robustness, and quality assurance.

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Key Takeaways

• The sourcing of oxycodone API is predominantly centered in India and China, with North American suppliers focusing on high-regulatory compliance.
• Regulatory adherence, including GMP certification and DMF submissions, remains pivotal in supplier selection.
• Diversification of supply sources mitigates risks associated with geopolitical and regulatory shifts.
• Transparency in documentation and supply chain integrity is essential for compliance and quality assurance.
• Technological innovations in API synthesis may influence future sourcing strategies toward more sustainable and cost-effective options.

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FAQs

Q1: What are the primary regions supplying oxycodone hydrochloride API globally?
A1: India and China dominate the supply, with significant manufacturing capabilities for oxycodone APIs. North American companies focus on high-compliance, often sourcing through partnerships or imports.

Q2: How do regulatory requirements impact API sourcing for opioids like Oxaydo?
A2: Suppliers must meet strict GMP standards and provide comprehensive documentation, such as DMFs and COA, to ensure quality and compliance, especially given the controlled nature of opioids.

Q3: Are there risks associated with sourcing oxycodone API from overseas manufacturers?
A3: Yes, risks include regulatory divergence, supply chain disruptions, and quality variability. Due diligence and ongoing audits are necessary to mitigate these risks.

Q4: How does supply chain diversification benefit API procurement?
A4: Diversification reduces dependency on a single source, mitigates geopolitical and regulatory risks, and ensures continuous supply.

Q5: What technological trends are influencing oxycodone API production?
A5: Advances in green chemistry and process optimization are improving manufacturing efficiency and reducing environmental footprints, potentially lowering costs and improving supply sustainability.

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References

[1] U.S. FDA. Guidance for Industry: Good Manufacturing Practice for Drugs. 2021.
[2] European Medicines Agency. Guidelines on Good Manufacturing Practice. 2022.
[3] GlobalData. API Manufacturing Trends in Oncology and Pain Management. 2022.
[4] IQVIA. Global API Supply Chain Analysis. 2021.
[5] Industry Reports. Global Narcotic API Market Overview. 2022.