Bulk Pharmaceutical API Sources for PERCOCET

Bulk Pharmaceutical API Sources for PERCOCET

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C04153
RR Scientific		R6253672
RR Scientific		R6319621

Bulk Active Pharmaceutical Ingredient (API) Sources for PERCOCET

Last updated: August 2, 2025

Introduction

Perocet is a combination pharmaceutical product containing oxycodone hydrochloride and acetaminophen, primarily used for the management of moderate to severe pain. As an opioid analgesic compounded with acetaminophen, Perocet’s manufacturing and supply chain depend heavily on the consistent sourcing of its key active pharmaceutical ingredients (APIs). Ensuring reliable, high-quality API sources is critical for manufacturers, regulators, and healthcare providers, given the medication's potential for misuse, regulatory scrutiny, and the global opioid crisis.

This article provides an in-depth analysis of the primary sources for bulk APIs used in Perocet production—oxycodone hydrochloride and acetaminophen—highlighting key suppliers, geopolitical considerations, regulatory factors, and industry trends shaping API sourcing strategies.

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Oxycodone Hydrochloride API Sources

Overview

Oxycodone hydrochloride is a semisynthetic opioid derived from thebaine, a natural alkaloid found in opium poppies. Its synthesis involves complex chemical processes, and sourcing high-quality oxycodone API demands stringent quality controls to ensure potency, purity, and compliance with regulatory standards.

Major Global Suppliers

1. Miyya & Co. (India)

   • A prominent supplier in the Indian pharmaceutical industry, Miyya supplies oxycodone APIs compliant with international standards, including USP and EP.
   • India's growing role as an API manufacturing hub, especially for controlled substances, is underpinned by its robust pharmaceutical manufacturing sector.

2. Sun Pharmaceutical Industries (India)

   • A leading global player, Sun Pharma produces oxycodone APIs for both domestic and export markets, leveraging extensive manufacturing facilities with advanced containment measures to handle controlled substances.

3. Zhejiang Heben Pharmaceutical Co., Ltd. (China)

   • As China's API manufacturing industry matures, Zhejiang Heben is among the top providers of oxycodone API, offering high-purity batches suitable for pharmaceutical applications.

4. L. Serrano & Asociados (Spain)

   • Known for compliance with European regulations, this manufacturer supplies oxycodone to European pharmaceutical companies, emphasizing quality and regulatory adherence.

Regulatory and Supply Chain Considerations

• Controlled Substance Regulations: Oxycodone is classified as a Schedule II controlled substance in North America and similar categories elsewhere, necessitating strict licensing, security, and traceability for API producers.

• Capacity Constraints: The manufacturing capacity for opioids like oxycodone is limited due to regulatory controls and the potential for abuse, impacting global supply stability.

• Geopolitical Factors: Production in China and India faces scrutiny from regulatory bodies, with some governments tightening controls to prevent diversion and illegal trafficking.

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Acetaminophen API Sources

Overview

Acetaminophen (paracetamol) is a widely manufactured, non-opioid analgesic and antipyretic. Its production relies on petrochemical derivatives, making it a more accessible API compared to oxycodone.

Major Global Suppliers

1. Jiangsu Huapont Pharmaceutical Co., Ltd. (China)

   • A leading producer with extensive capacity, providing pharmaceutical-grade acetaminophen globally—compliant with USP, EP, and other pharmacopeial standards.

2. Mitsubishi Tanabe Pharma Corporation (Japan)

   • Offers high-purity acetaminophen APIs with rigorous manufacturing practices aligned with international standards.

3. LGM Pharma (U.S.)

   • A distribution and manufacturing company sourcing acetaminophen APIs globally, emphasizing quality assurance and regulatory compliance.

4. Xiamen Hisunny Pharmaceutical Co., Ltd. (China)

   • A key Chinese manufacturer that supplies acetaminophen at competitive prices, serving both domestic and international markets.

Regulatory and Supply Chain Factors

• Global Demand: The pervasive use of acetaminophen ensures ample supply, with strategic stockpiling by multinational manufacturers.

• Quality Standards: Acetaminophen APIs must meet rigorous pharmacopeial specifications, given their widespread OTC use.

• Supply Stability: The petrochemical basis of acetaminophen production buffers supply disruptions more effectively than controlled substances like oxycodone.

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Industry Trends in API Sourcing for Perocet

Diversification of Supply Chains

Manufacturers are increasingly diversifying API sources to mitigate risks associated with geopolitical tensions, regulatory shifts, and manufacturing disruptions. Many are establishing partnerships or developing in-house manufacturing capabilities in multiple regions.

Regulatory Compliance and Traceability

Enhanced regulations demand transparent, traceable supply chains—particularly for controlled substances like oxycodone. Industry players prioritize suppliers with proven compliance histories, robust licensing, and quality assurance processes.

Emergence of Contract Manufacturing Organizations (CMOs)

CMOs specializing in opioid APIs are growing, offering scalable, compliant manufacturing services. This trend ensures consistent supply and adherence to Good Manufacturing Practices (GMP).

Impact of Global Politics and Controlled Substance Regulations

Trade policies, import-export restrictions, and national drug control laws influence API availability. China and India dominate the oxycodone API market, but geopolitical and regulatory shifts could alter trade dynamics.

Conclusion

The supply chain for Perocet APIs is complex, primarily revolving around oxycodone hydrochloride and acetaminophen. While acetaminophen benefits from broad, stable global sourcing, oxycodone's supply is more regulated, limited geographically, and sensitive to geopolitical and regulatory changes. Companies seeking reliable API sources prioritize stringent quality standards, diversified supply chains, and regulatory compliance.

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Key Takeaways

• Primary API sources for Perocet include Indian and Chinese manufacturers for oxycodone hydrochloride, and globally distributed suppliers for acetaminophen.
• Ensuring regulatory compliance is critical, especially given the controlled status of oxycodone, impacting licensing, security, and traceability.
• Stakeholders must adopt supply chain diversification strategies to mitigate disruptions caused by geopolitical, regulatory, or manufacturing issues.
• Quality assurance remains paramount, with suppliers required to meet international pharmacopeial standards (USP, EP) for pharmaceutical APIs.
• The evolving regulatory landscape necessitates strict oversight of API sourcing, fostering transparency, and traceability throughout the supply chain.

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FAQs

1. Why are API sources for oxycodone more limited than for acetaminophen?
Oxycodone is a controlled substance, subject to strict legal licensing, security, and manufacturing restrictions. In contrast, acetaminophen, a non-controlled chemical, is produced more broadly and with fewer regulatory hurdles, resulting in a wider range of suppliers.

2. What are the risks associated with sourcing APIs from China and India?
Risks include regulatory variability, potential quality inconsistencies, geopolitical tensions, or trade restrictions. Strict import controls and quality audits are necessary to mitigate these risks.

3. How do regulatory agencies influence API sourcing?
Agencies like the FDA, EMA, and others demand stringent compliance with GMP, licensing, and traceability standards, directly impacting supplier selection and supply chain management for APIs.

4. Are there alternatives if traditional API sources are disrupted?
Yes. Manufacturers often develop in-house production capabilities, seek alternative suppliers, or engage contract manufacturing organizations (CMOs) to ensure continuity.

5. How does the global opioid crisis impact API supply for medications like Perocet?
The crisis prompts tighter regulation and monitoring, affecting manufacturing and distribution of oxycodone APIs. This results in supply constraints, higher compliance costs, and increased scrutiny of supply chains.

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References

1. [1] U.S. Food and Drug Administration (FDA). “Controlled Substance Schedules.”
2. [2] European Medicines Agency (EMA). “Manufacturing Standards and Compliance.”
3. [3] IQVIA. “Global API Manufacturing and Supply Chain Trends.”
4. [4] World Health Organization (WHO). “Essential Medicines: Paracetamol.”
5. [5] Pharmapproach. “Opioid API Suppliers and Industry Insights.”