OXYCODONE AND ASPIRIN: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma Llc	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride	TABLET;ORAL	040910	ANDA	Epic Pharma, LLC	42806-061-01	100 TABLET in 1 BOTTLE (42806-061-01)	2020-07-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

The pharmaceutical landscape for drugs like oxycodone and aspirin is complex and highly regulated. These medications serve distinct therapeutic roles: oxycodone as an opioid analgesic for severe pain management, and aspirin primarily as an anti-inflammatory and antiplatelet agent. Ensuring a reliable supply chain is critical for healthcare providers, pharmacies, and regulators. This report provides an in-depth overview of the key suppliers, manufacturing hubs, and supply chain dynamics for these two drugs, highlighting their current market landscape, challenges, and opportunities.

Oxycodone: The Supply Chain and Key Suppliers

Global Manufacturing Landscape

Oxycodone is a Schedule II controlled substance within the United States and is classified similarly in many jurisdictions due to its high potential for abuse and addiction [1]. Its production is predominantly concentrated in countries with robust pharmaceutical manufacturing capabilities, such as the United States, China, and India.

United States: Major pharmaceutical companies like Purdue Pharma, Mallinckrodt, and Teva Pharmaceuticals hold significant manufacturing licenses and produce oxycodone for domestic and international markets [2]. Purdue Pharma's involvement has historically been pivotal despite recent legal challenges and reformulations aimed at abuse deterrence.

China: As a substantial supplier of raw materials, China produces the key precursor chemicals and intermediate compounds needed for oxycodone synthesis. Companies such as Jiangsu Hengrui Medicine and Zhejiang Hepa Pharmaceutical are notable for their role in bulk production [3].

India: Indian pharmaceutical giants like Sun Pharmaceutical Industries and Cipla manufacture oxycodone and its intermediates for export, benefiting from cost-effective manufacturing and extensive export networks [4].

Regulatory and Supply Challenges

The oxycodone supply chain faces tight regulations due to the drug’s abuse potential. Regulatory agencies, like the U.S. Drug Enforcement Administration (DEA), impose strict controls on manufacturing, distribution, and export. Consequently, companies must navigate complex licensing processes, inventory tracking, and compliance measures [5].

Supply disruptions have occurred due to:

Regulatory crackdowns: Leading to temporary shortages or licensing delays.
Supply chain disruptions: From geopolitical tensions or pandemic-related manufacturing shutdowns.
Legal liabilities and litigations: Impacting company operations and production capacity.

Emerging Trends

To mitigate risks, manufacturers are investing in:

Diversification of suppliers: Sourcing intermediates from multiple countries.
Advanced manufacturing techniques: Enhancing process security and reducing reliance on vulnerable supply chains.
Automation and digital tracking: Improving compliance and traceability.

Aspirin: The Global Supplier Network

Manufacturing Landscape

Aspirin, one of the oldest and most widely used medications, benefits from a well-established global manufacturing ecosystem. Its synthesis involves relatively simple processes, allowing a broad base of producers.

Leading Producers:

Bayer AG: The originator of modern aspirin, Bayer remains a leading manufacturer with global production facilities and supply agreements [6].
Hindustan Unilever and Cipla (India): Major players in generic aspirin production, especially for emerging markets.
Johnson & Johnson and Novartis: Maintain large-scale manufacturing and distribution capacities for aspirin and related salicylates.

Production Regions:

Europe: Centers in Germany and Switzerland are prominent for high-quality formulations.
Asia: India and China possess vast manufacturing bases supplying both generic and branded aspirin products globally.
North America: The U.S. and Canada host key manufacturing plants, emphasizing quality and regulatory compliance.

Supply Dynamics and Stability

Aspirin’s supply chain is characterized by:

Stable raw material availability: Salicylic acid precursors are widely produced.
Low regulatory barriers: Compared to opioids, aspirin faces fewer restrictions, facilitating consistent supply.
Cost-efficiency: Competitive manufacturing costs, especially in India and China, support global distribution.

Challenges include:

Market saturation: Leading to intense price competition.
Regulatory variations: Between countries affecting batch approvals and labeling.
Quality assurance: Maintaining GMP standards across diverse manufacturing sites.

Supply Chain Risks and Regulatory Considerations

For both oxycodone and aspirin, supply chain resilience hinges on adherence to regulatory standards, geopolitical stability, and robust manufacturing infrastructure. The opioid market faces heightened scrutiny, with regulators enforcing strict controls to prevent diversion and misuse.

Key risks include:

Regulatory restrictions: Restrict raw material export/import, especially for controlled substances.
Intellectual property issues: In the case of proprietary formulations or formulations under patent.
Geopolitical tensions: Affecting cross-border supply flows and raw material access.
Supply disruptions: Due to pandemics, natural disasters, or manufacturing recalls.

Emerging Supply Chain Strategies

To mitigate these risks, stakeholders are adopting strategies such as:

Enhancing local manufacturing capacity.
Developing alternative suppliers and regional hubs.
Investing in advanced analytics for demand forecasting.
Implementing strict compliance protocols and traceability systems.

Conclusion

The landscape of suppliers for oxycodone and aspirin underscores the importance of diversified, compliant, and resilient supply channels. While aspirin benefits from a mature, stable network with broad manufacturing bases, oxycodone’s supply chain remains highly regulated and concentrated, necessitating careful navigation of legal and geopolitical risks.

Ensuring continuity and regulatory compliance in sourcing these drugs is vital for healthcare providers and pharmaceutical companies. Strategic supplier diversification, technological innovations, and proactive regulatory engagement will remain critical in sustaining these essential medicines.

Key Takeaways

Oxycodone’s supply chain is concentrated in the US, China, and India, with strict regulatory oversight influencing production and distribution.
Aspirin benefits from a mature global manufacturing network, with key producers in Europe and Asia, leading to stable supply.
Regulatory and geopolitical risks are key considerations, especially for opioids, necessitating diversification and robust compliance.
Innovations like digital tracking and regional manufacturing hubs are essential strategies for supply chain resilience.
Collaboration with regulatory agencies and adherence to Good Manufacturing Practices (GMP) are critical for ongoing supply stability.

FAQs

1. Who are the leading suppliers of oxycodone globally?
Major manufacturers include Purdue Pharma, Mallinckrodt, and Teva Pharmaceuticals in the US, alongside Chinese producers like Jiangsu Hengrui Medicine and Indian companies such as Sun Pharmaceutical Industries.

2. What regulatory challenges affect the supply of oxycodone?
Strict controls by authorities like the DEA, license restrictions, and international regulations on controlled substances limit supply flexibility and create potential bottlenecks.

3. Which companies dominate aspirin manufacturing worldwide?
Bayer AG remains the original and primary producer, supplemented by Indian firms like Cipla and Hindustan Unilever, and multinational corporations like Johnson & Johnson.

4. Are supply disruptions common for aspirin and oxycodone?
Supply disruptions are less common for aspirin due to its mature manufacturing ecosystem, but oxycodone's supply is more vulnerable to regulatory changes and geopolitical issues.

5. How are pharmaceutical companies mitigating supply chain risks for these drugs?
Strategies include supplier diversification, regional manufacturing expansion, digital traceability, and maintaining compliance with international standards.

References

[1] U.S. Drug Enforcement Agency. (2021). Controlled Substances Scheduling.
[2] Pharmaceutical Technology. (2020). Key Players in Oxycodone Production.
[3] Chinese Pharmaceutical Industry Reports. (2022). Manufacturing and Raw Material Supply.
[4] Indian Pharmaceutical Market Analysis. (2021). Key Manufacturers and Export Trends.
[5] U.S. DEA. (2022). Regulations on Production and Distribution of Opioids.
[6] Bayer AG. (2022). Aspirin Production and Market Data.

Suppliers and packagers for OXYCODONE AND ASPIRIN