PERCOCET: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330	ANDA	ENDO USA, Inc.	60951-602-70	100 TABLET in 1 BOTTLE (60951-602-70)	2000-05-26
Endo Operations	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330	ANDA	ENDO USA, Inc.	60951-602-85	500 TABLET in 1 BOTTLE (60951-602-85)	2000-05-26
Endo Operations	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330	ANDA	ENDO USA, Inc.	60951-700-70	100 TABLET in 1 BOTTLE (60951-700-70)	2003-03-06
Endo Operations	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330	ANDA	ENDO USA, Inc.	60951-701-70	100 TABLET in 1 BOTTLE, PLASTIC (60951-701-70)	2003-03-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Percocet, a widely prescribed opioid analgesic, combines oxycodone with acetaminophen to manage moderate to severe pain. Its efficacy depends heavily on a complex supply chain involving raw material providers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution networks. Ensuring reliable, compliant suppliers is critical amid stringent regulatory landscapes and increasing scrutiny over opioid distribution. This analysis explores current Percocet suppliers, key manufacturing players, supply chain dynamics, and strategic considerations for stakeholders.

Overview of Percocet Supply Chain

Percocet’s production hinges on sourcing high-quality APIs—oxycodone and acetaminophen—and robust pharmaceutical manufacturing processes. The supply chain begins with raw material extraction or synthesis, followed by chemical processing, formulation, packaging, and distribution. Due to its controlled status under federal and international laws, the entire chain must adhere to Good Manufacturing Practices (GMP), strict documentation, and regulatory standards enforced by agencies such as the FDA (Food and Drug Administration) in the U.S.

Key Suppliers of API for Percocet

1. Oxycodone API Suppliers

Oxycodone is a semi-synthetic opioid derived from thebaine, a component of opium poppy. Its manufacturing is predominantly controlled by global pharmaceutical giants, with some smaller entities also active.

Mallinckrodt Pharmaceuticals: Historically, one of the largest producers of oxycodone in the U.S., with extensive API manufacturing capabilities. Their supply chain has faced disruptions due to regulatory actions but remains a pivotal supplier domestically.
Sun Pharmaceutical Industries: An Indian company with significant API manufacturing infrastructure, providing oxycodone to global markets, including the U.S. and Europe.
Hikma Pharmaceuticals: Known for API production, Hikma supplies oxycodone to various generics manufacturers with strict compliance to GMP standards.
Teva Pharmaceuticals: As a leading generic drug manufacturer, Teva sources oxycodone API from multiple GMP-certified suppliers, including vertically integrated manufacturing operations.

2. Acetaminophen API Suppliers

Acetaminophen is synthesized from para-aminophenol (p-AP), with several global players engaged in its production:

Johnson Matthey: A major supplier of pharmaceutical-grade acetaminophen, known for high-quality standards.
Hubei Hongyuan Pharmaceutical Co., Ltd. (China): Emerging as a significant API producer, with increasing exports to Western markets.
BASF: Offers pharmaceutical-grade acetaminophen and related intermediates, emphasizing purity and consistency.
Mitsubishi Chemical: Supplies acetaminophen for various formulations, including combination analgesics like Percocet.

Formulation and Final Product Manufacturers

Percocet is formulated by specialized contract manufacturers and large pharmaceutical companies possessing extensive GMP-compliant facilities:

Endo International: Historically a primary manufacturer of Percocet under the brand name Percocet, though recent regulatory actions have curtailed U.S. production.
Teva Pharmaceuticals and Mylan: Produce generic versions, sourcing API from multiple suppliers and adhering to strict quality standards.
Sun Pharmaceutical and Dr. Reddy’s Laboratories: Also manufacture generic Percocet formulations, often utilizing APIs from regional or international suppliers.

Regulatory and Compliance Considerations

Given Percocet's status as a Schedule II controlled substance under the Controlled Substances Act, suppliers must carry current registration with the DEA, and manufacturing must be compliant with DEA quotas, GMP, and other regulations. Recent crackdowns and compliance audits have heightened scrutiny across the supply chain.

Supply chain integrity is paramount, especially given the potential for diversion or counterfeit products. The Drug Enforcement Administration (DEA) periodically audits manufacturing and distribution channels to prevent illicit diversion.

Supply Chain Risks and Challenges

Regulatory Scrutiny and Crackdowns: Heightened DEA enforcement affects sourcing, especially for oxycodone APIs, leading to supply shortages or increased costs.
Geopolitical Factors: Many APIs are sourced from China and India, exposing manufacturers to geopolitical shifts, trade tariffs, and export restrictions.
Quality Assurance: Ensuring API purity and regulatory compliance is critical. Substandard API suppliers risk contamination, dangerous impurities, or regulatory sanctions.
Market Demand Fluctuations: The opioid epidemic and regulatory measures have led to fluctuating demand, impacting supplier stability and production planning.

Emerging Trends and Strategic Considerations

API Vertical Integration: Some pharmaceutical companies pursue vertical integration to gain greater control over source quality and supply stability.
Supply Chain Diversification: Diversifying API sources reduces dependency risks; companies increasingly seek suppliers across multiple geographies.
Regulatory Compliance & Traceability: Advanced serialization and track-and-trace systems enhance supply chain security and transparency.
Alternative Formulations: Development of non-opioid alternatives to Percocet aims to mitigate supply chain risks associated with opioids.

Conclusion

The supply chain for Percocet involves complex, tightly regulated segments, dominated by large multinational pharmaceutical companies and API manufacturers from North America, Europe, and Asia. Ensuring quality, compliance, and stability requires strategic collaboration with reputable suppliers, comprehensive risk management, and adherence to evolving regulatory landscapes. Stakeholders must monitor geopolitical shifts, enforce proper GMP standards, and implement robust traceability systems to secure an uninterrupted and compliant supply of Percocet.

Key Takeaways

Major API suppliers for Percocet include Mallinckrodt, Sun Pharma, Hikma, Johnson Matthey, and BASF.
US-based manufacturing of Percocet has decreased due to regulatory pressures, leading to reliance on international suppliers and contract manufacturers.
Compliance with DEA, FDA, and GMP standards is essential for legal and safe supply chain management.
Geopolitical and regulatory shifts pose ongoing risks, necessitating diversified sourcing strategies.
Efforts toward vertical integration and alternative formulations are emerging to mitigate supply vulnerabilities.

Frequently Asked Questions

Q1: Which companies are the primary manufacturers of Percocet currently in the US?
A: The primary manufacturers included Endo International and Teva Pharmaceuticals. However, due to regulatory changes, domestic production has significantly decreased, with many generic producers sourcing APIs globally.

Q2: What are the main risks associated with Percocet’s supply chain?
A: Risks include regulatory enforcement actions, geopolitical disruptions affecting API sourcing from China and India, quality control issues, and market demand fluctuations due to regulatory crackdowns.

Q3: How do suppliers ensure API quality and regulatory compliance?
A: Suppliers adhere to Good Manufacturing Practices, undergo regular audits by regulatory authorities, and implement serialization and traceability systems to ensure product integrity.

Q4: Are there geopolitical concerns impacting Percocet supply chain stability?
A: Yes. Heavy dependence on APIs from China and India makes the supply chain vulnerable to trade restrictions, tariffs, and export controls.

Q5: What strategic measures can companies adopt to mitigate supply chain risks?
A: Diversify API sourcing, pursue vertical integration, establish long-term supplier relationships, and invest in supply chain transparency and compliance monitoring.

Suppliers and packagers for PERCOCET

PERCOCET

Suppliers for the Pharmaceutical Drug: Percocet