OXYCODONE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	205177	ANDA	ANI Pharmaceuticals, Inc.	62559-167-01	100 CAPSULE in 1 BOTTLE (62559-167-01)	2016-06-10
Avanthi Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	202773	ANDA	KVK-TECH, INC.	10702-023-01	100 CAPSULE in 1 BOTTLE (10702-023-01)	2015-08-20
Avanthi Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	202773	ANDA	KVK-TECH, INC.	10702-023-06	60 CAPSULE in 1 BOTTLE (10702-023-06)	2015-08-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Oxycodone hydrochloride is a potent opioid analgesic widely prescribed for managing moderate to severe pain. Its controlled status and high potential for abuse position it as a highly regulated pharmaceutical product globally. Understanding the landscape of suppliers—ranging from raw material producers to finished drug manufacturers—is critical for stakeholders involved in procurement, distribution, regulation, and strategic planning within the pharmaceutical supply chain.

This comprehensive overview examines key suppliers at various stages—including raw material extraction, active pharmaceutical ingredient (API) manufacturing, formulation, and distribution—highlighting market dynamics, regulatory considerations, and procurement strategies for Oxycodone hydrochloride.

Raw Material Suppliers and API Manufacturers

1. Raw Material Suppliers

Oxycodone hydrochloride synthesis begins with precursor chemicals, primarily narcotic alkaloids derived from the papaver somniferum plant (opium poppy). The extraction of opium alkaloids such as thebaine and oripavine constitutes the initial stage for synthetic modification into oxycodone.

Key Suppliers:

Papaver Somniferum Cultivators: Countries such as India, Turkey, Australia, and Mexico dominate opium poppy cultivation. The cultivation quality and regulation influence the purity and yield of subsequent alkaloid extraction. India, notably, is one of the world’s largest producers of opium for pharmaceutical use under strict government licensing [1].
Precursor Chemical Suppliers: Companies providing specialized chemicals used in subsequent synthesis steps, including thebaine and oripavine, are integral. These precursors are often sourced from licensed chemical suppliers compliant with international drug control treaties.

2. Active Pharmaceutical Ingredient (API) Manufacturers

The active ingredient, oxycodone hydrochloride, is synthesized through complex chemical processes involving thebaine or similar alkaloids. Several global pharmaceutical companies manufacture oxycodone API under strict regulatory oversight:

Mallinckrodt Pharmaceuticals: A leading global supplier with extensive API manufacturing facilities, including oxycodone, adhering to Good Manufacturing Practices (GMP). Mallinckrodt's global reach ensures supply continuity and regulatory compliance.
Patheon (a part of Thermo Fisher Scientific): Provides API manufacturing services globally, with capabilities for oxycodone synthesis, particularly serving generic pharmaceutical companies.
Noramco Inc.: Specializes in producing controlled substances, including oxycodone API, with a focus on high-quality standards and regulatory compliance in the U.S. and international markets.
Domestic Chinese API Producers: Several Chinese API manufacturers, such as Zhejiang Hisun Pharmaceutical Co., Ltd., supply oxycodone API to international pharmaceutical firms, subject to export and regulatory constraints.

Regulatory Compliance and Licensing

Manufacturers must comply with stringent regulatory frameworks such as the Drug Enforcement Administration (DEA) in the U.S., European Medicines Agency (EMA) in the EU, and similar bodies globally. API suppliers require licenses for controlled substance manufacturing, and export/import processes are strictly monitored [2].

Finished Dosage Form Manufacturers

Once the API is obtained, pharmaceutical companies formulate oxycodone into various dosage forms:

Extended-release tablets (e.g., OxyContin)
Immediate-release tablets
Injectable formulations (less common)

Major pharmaceutical firms with manufacturing capability include:

Purdue Pharma: Historically, the original manufacturer of OxyContin, though its current status involves bankruptcy and restructuring amidst lawsuits.
Teva Pharmaceuticals: A leading generic manufacturer with extensive oxycodone product portfolio.
Eli Lilly: Manufactures oxycodone-containing formulations for various regions.
MediRx Pharmaceutical: Distributes oxycodone formulations in different markets, subject to regional regulatory approval.

Regional manufacturers also contribute significantly to local markets, often sourcing API from international suppliers, demonstrating an interconnected global supply chain.

Key Geographical Suppliers and Market Dynamics

United States

As the largest consumer of oxycodone in North America, the U.S. tightly regulates the supply chain via the DEA, which controls manufacturing quotas and licensing. Prominent API producers such as Noramco and domestic pharmaceutical companies dominate the supply landscape.

China

China serves as a significant API exporter for controlled substances, including oxycodone. However, recent regulatory shifts and international scrutiny have tightened export controls, affecting global supply dynamics [3].

India and Other Countries

India's regulated opium cultivation and licensed API manufacturing infrastructure position it as an essential supplier for both domestic and international markets.

Europe

European API producers operate within a stringent regulatory environment, supplying both regional and international pharmaceutical firms.

Supply Chain Challenges and Considerations

Regulatory Stringency: Strict licensing, export controls, and international treaties (e.g., UN Single Convention on Narcotic Drugs) heavily influence supplier options and market access.
Supply Security: The high regulatory barriers and geopolitical considerations pose risks of supply disruptions, especially given the narcotic nature of oxycodone.
Manufacturing Capacity: Limited capacity for API production due to regulatory costs and restrictions can impact the availability of oxycodone formulations.
Diversification: Companies often mitigate risks through diversified sourcing strategies, engaging multiple suppliers across different regions.

Legal and Ethical Considerations

The global supply chain for oxycodone is heavily scrutinized to prevent diversion, misuse, and illegal trafficking. Suppliers must maintain rigorous compliance with international controls, including tracking and reporting obligations.

Regulatory and Industry Implications

Global Oversight: Regulatory bodies continuously monitor manufacturing and distribution practices, aiming to balance legitimate medical needs with abuse prevention [4].
Traceability and Transparency: Blockchain and advanced tracking systems are increasingly adopted to provide transparent supply chains.
Emerging Alternatives: The overdose crisis has prompted efforts to develop non-opioid analgesics and abuse-deterrent formulations, potentially impacting demand and supplier landscapes.

Conclusion

The supply chain for oxycodone hydrochloride encompasses a complex network of licensed opium cultivation, controlled substance API manufacturers, and pharmaceutical formulators—each operating within a highly regulated environment. Major players such as Mallinckrodt, Noramco, and Chinese API producers significantly influence global availability. Navigating this landscape requires careful compliance with international and regional regulations to ensure the secure and ethical distribution of this potent opioid.

Key Takeaways

Diversify Sources: Establish relationships with multiple licensed API suppliers across different geographies to mitigate supply disruptions.
Prioritize Compliance: Strict adherence to regulatory standards is essential given the controlled status of oxycodone.
Monitor Regulatory Changes: Geopolitical shifts and international treaties impact supply chain dynamics; ongoing vigilance is necessary.
Emphasize Traceability: Implement advanced tracking methods to ensure supply chain transparency and prevent diversion.
Evaluate Alternative Strategies: Invest in research for non-opioid pain management solutions to reduce dependence on oxycodone.

FAQs

Q1: Who are the leading international suppliers of oxycodone hydrochloride API?
A: Major suppliers include Mallinckrodt Pharmaceuticals, Noramco Inc., and Chinese API manufacturers such as Zhejiang Hisun Pharmaceutical. These companies operate under strict licensing and compliance regimes to produce and export controlled substances [1][2].

Q2: How do regulations affect the global supply chain of oxycodone?
A: Regulations by agencies like the DEA and EMA impose licensing, quotas, and export controls that restrict manufacturing capacities and international trade, minimizing diversion risks but complicating supply logistics [4].

Q3: Are there regional differences in oxycodone suppliers?
A: Yes. In North America, domestic manufacturers dominate, while in Asia, Chinese API producers are prominent. Europe relies on both local and international API sources, with varying regulatory environments influencing supply options.

Q4: What risks threaten the stability of oxycodone supply?
A: Risks include regulatory tightening, geopolitical tensions, manufacturing capacity constraints, illicit diversion, and disruptions in opium poppy cultivation or API production.

Q5: How is technology improving transparency in the oxycodone supply chain?
A: Adoption of blockchain-based tracking and serialization enhances traceability, helping prevent diversion and ensuring compliance with regulatory standards.

References

[1] United Nations Office on Drugs and Crime. (2021). World Drug Report 2021.
[2] U.S. Drug Enforcement Administration. (2022). Controlled Substances Act – Registration and Licensing.
[3] Reuters. (2022). Chinese regulators tighten export controls on narcotic APIs amid international scrutiny.
[4] European Monitoring Centre for Drugs and Drug Addiction. (2020). Supply reduction and regulation strategies.

This detailed analysis provides a strategic overview essential for businesses and regulators involved in the oxycodone hydrochloride supply chain.

Suppliers and packagers for OXYCODONE HYDROCHLORIDE