Suppliers and packagers for generic pharmaceutical drug: ASPIRIN; OXYCODONE HYDROCHLORIDE

ASPIRIN; OXYCODONE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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

Suppliers for the Pharmaceutical Drugs: Aspirin and Oxycodone Hydrochloride

Last updated: July 29, 2025

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Introduction

Identifying reliable suppliers for pharmaceutical-grade aspirin and oxycodone hydrochloride is critical for pharmaceutical companies, healthcare providers, and regulatory bodies. These drugs serve diverse therapeutic purposes and are subject to strict regulatory oversight, emphasizing the importance of sourcing from reputable manufacturers. This comprehensive analysis examines the global landscape of suppliers, focusing on manufacturing capabilities, regulatory compliance, and supply chain stability.

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Aspirin Suppliers

Market Overview

Aspirin (acetylsalicylic acid) remains one of the most widely used non-prescription medications worldwide, primarily for pain relief, anti-inflammatory effects, and cardiovascular protection. The global demand sustains a competitive supply chain comprising major multinational corporations and generic drug manufacturers.

Major Aspirin Manufacturers

1. Bayer AG
   As the original inventor of aspirin, Bayer continues to be a dominant supplier with a globally integrated manufacturing network. Its facilities adhere to rigorous regulatory standards, including FDA, EMA, and other regional authorities.

2. Hoffmann-La Roche
   Roche provides pharmaceutical-grade aspirin primarily for prescription purposes, with manufacturing plants complying with international GMP standards.

3. Sinopharm Group
   A leading Chinese state-owned enterprise, Sinopharm supplies bulk aspirin for both domestic consumption and export. Its manufacturing processes meet GMP certification, and it has a vast distribution network in Asia and beyond.

4. Mylan (now part of Viatris)
   Premier generic drug producer, Mylan supplies aspirin globally, emphasizing affordable quality. Its manufacturing facilities are certified by multiple regulatory agencies, including USFDA and EMA.

5. Prasco Laboratories
   Specializing in over-the-counter medicines, Prasco supplies bulk aspirin meeting stringent U.S. and European regulatory standards.

Key Considerations in Aspirin Supply

• Regulatory Certification: Suppliers must possess GMP compliance, ISO certification, and regional regulatory approvals.
• Production Capacity: Capacity fluctuations can affect supply, especially amidst geopolitical tensions or raw material shortages.
• Raw Material Supply: The primary raw material, salicylic acid, influences manufacturing reliability. Major producers originate from countries like China and India.

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Oxycodone Hydrochloride Suppliers

Market Overview

Oxycodone hydrochloride, a potent semi-synthetic opioid analgesic, is classified as a controlled substance due to its abuse potential. Strict manufacturing regulations, extensive licensing, and security measures govern its supply chain. The global market involves a handful of incumbents with specialized manufacturing capabilities.

Key Global Suppliers

1. Mallinckrodt Pharmaceuticals
   A leading supplier of oxycodone, Mallinckrodt operates licensed facilities in the US and Europe. It supplies both branded and generic formulations, ensuring compliance with DEA and FDA regulations.

2. Purdue Pharma
   Historically significant in oxycodone manufacturing, Purdue's production has faced scrutiny and legal challenges, prompting the transition of certain manufacturing rights. Nonetheless, it maintains licensing agreements for specific formulations.

3. Mitsubishi Tanabe Pharma Corporation
   Based in Japan, Mitsubishi supplies oxycodone for regional markets, emphasizing strict adherence to regulatory standards such as PMDA and GMP.

4. Sun Pharmaceutical Industries
   As one of India's largest generic manufacturers, Sun Pharma produces oxycodone hydrochloride for export to regulated markets, maintaining compliance with USFDA, UK MHRA, and other agencies.

5. Fontec Pharmaceuticals
   A notable generic manufacturer with facilities in both India and Europe, Fontec supplies oxycodone to various markets, adhering to stringent Good Manufacturing Practice (GMP) standards.

Special Considerations in Supply Chain

• Regulatory Controls: Due to its Controlled Substance Act classification in the US and similar regulations elsewhere, suppliers must maintain extensive licensing and security measures.
• Supply Chain Security: Counterfeit prevention and theft deterrence are essential in the oxycodone supply chain.
• Manufacturing Capacity: Capacity constraints often emerge because of regulatory limitations, increased demand, or geopolitical factors.

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Regulatory and Compliance Landscape

GMP and Certification

Both aspirin and oxycodone suppliers must perpetually maintain Good Manufacturing Practice (GMP) standards. For oxycodone, compliance with DEA licensing and statutory controls is mandatory, requiring secure facilities, accurate record-keeping, and regular audits.

Regional Regulations

• United States: FDA approvals, DEA scheduling, and import/export controls govern oxycodone sourcing.
• European Union: EMA Certification and compliance with Good Distribution Practice (GDP).
• China and India: Growing manufacturing hubs with GMP-certified plants catering to global markets, yet supply chains still face scrutiny regarding regulatory oversight.

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Supply Chain Challenges and Risks

• Raw Material Shortages: Particularly for aspirin, supply can be constrained by the availability of raw salicylic acid, with geopolitical factors influencing raw material production.
• Regulatory Changes: Amendments in drug scheduling or manufacturing standards can disrupt supply flows.
• Legal and Ethical Hurdles: The opioid crisis led to tighter controls and decreased supply chain transparency concerning oxycodone, impacting legal manufacturing and distribution.

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Emerging Trends and Future Outlook

• Diversification of Suppliers: Companies increasingly diversify sources, especially for oxycodone, to mitigate regulatory risks and ensure stable supply.
• Manufacturing Localization: Shift toward local manufacturing in key markets reduces dependency on foreign suppliers amid geopolitical tensions.
• Quality Assurance Enhancements: Investment in advanced manufacturing and supply chain security minimizes counterfeit and diversion risks.

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Key Takeaways

• Reputable manufacturers are critical: Ensure suppliers possess ISO, GMP, and specific regional certifications, particularly for controlled substances like oxycodone.
• Regional differences: Asia dominates aspirin production, while specialized, licensed manufacturers supply oxycodone under strict regulatory oversight.
• Supply chain resilience: Diversify sourcing to prevent disruptions caused by geopolitical tensions, raw material shortages, or regulatory changes.
• Regulatory compliance: Vigilance regarding changing laws and licensing requirements is crucial for uninterrupted procurement.
• Future prospects: Increasing localization and technological advancements are poised to enhance supply chain security and compliance.

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FAQs

1. Which are the top global suppliers of pharmaceutical-grade aspirin?
Major suppliers include Bayer AG, Hoffmann-La Roche, Sinopharm Group, Mylan (Viatris), and Prasco Laboratories, all adhering to stringent GMP standards.

2. Who are the leading manufacturers of oxycodone hydrochloride, and what regulatory hurdles do they face?
Leading manufacturers include Mallinckrodt, Purdue Pharma, Mitsubishi Tanabe Pharma, Sun Pharma, and Fontec Pharmaceuticals. Strict licensing, DEA controls, and security measures are vital regulatory requirements.

3. How can companies ensure the quality of aspirin and oxycodone suppliers?
By verifying GMP certification, regional regulatory approvals, manufacturing audits, and compliance with ISO standards. Maintaining ongoing supplier audits mitigates quality risks.

4. What are the risks associated with sourcing oxycodone hydrochloride?
Risks include regulatory restrictions, supply disruptions, counterfeit products, theft, and diversion. Ensuring validated supply chains and compliance is essential.

5. What future trends are shaping the pharmaceutical supply chain for these drugs?
Increased localization, supply diversification, adoption of advanced tracking technologies, and stricter regulatory oversight aim to improve resilience and compliance.

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References

[1] Bayer AG Corporate Website
[2] Hoffmann-La Roche Corporate Reports
[3] Sinopharm Group Annual Report
[4] Mylan Corporate Overview
[5] U.S. Drug Enforcement Administration (DEA) Regulations on Controlled Substances