Bulk Pharmaceutical API Sources for PERCODAN

Bulk Pharmaceutical API Sources for PERCODAN

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-16043
ABI Chem		AC1Q4DTG
ChemMol		30105082
Chembase.cn		380
Chembase.cn		130370
Alsachim		3226
Angene Chemical		AGN-PC-0OHTAS

Bulk Active Pharmaceutical Ingredient (API) Sources for: PERCODAN

Last updated: August 2, 2025

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Introduction

Percodan is a brand name for a combination analgesic drug comprising oxycodone hydrochloride and aspirin. Primarily used to manage moderate to severe pain, Percodan’s efficacy depends on the purity and quality of its active pharmaceutical ingredients (APIs): oxycodone and aspirin. Given the complexities of opioid regulations and manufacturing standards, sourcing high-quality APIs is critical for pharmaceutical companies to ensure safety, compliance, and efficacy.

This article explores the global landscape of API suppliers for percodan’s key constituents—oxycodone and aspirin—highlighting top manufacturers, sourcing considerations, regulatory frameworks, and market dynamics.

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Overview of Percodan and Its API Components

Percodan combines two APIs:

• Oxycodone Hydrochloride: A semi-synthetic opioid analgesic derived from thebaine, known for potent pain relief.
• Aspirin (Acetylsalicylic Acid): A non-steroidal anti-inflammatory drug (NSAID) providing analgesic, antipyretic, and anti-inflammatory effects.

The sourcing of these APIs involves navigating complex manufacturing processes, regulatory standards, and global supply chains.

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Oxycodone API Sourcing

Key Manufacturers and Suppliers

Oxycodone, classified as a controlled substance, has a limited pool of API producers predominantly located in regions with robust regulatory oversight, such as North America, Europe, and India.

1. Domino Chemicals (USA)

   • A major producer of semi-synthetic opioids.
   • Supplies oxycodone for pharmaceutical applications, complying with FDA and DEA regulations.

2. Mundipharma International (UK)

   • Engages in manufacturing and distributing oxycodone APIs.
   • Noted for strict adherence to Good Manufacturing Practices (GMP).

3. Baikowski Eckarts (Germany)

   • Specializes in high-purity oxycodone API production tailored for pharmaceutical injection and oral formulations.

4. Sun Pharmaceutical Industries Ltd. (India)

   • Among leading Indian API manufacturers producing oxycodone under strict regulatory standards.
   • Supplies both API and finished formulations to global markets.

5. Qingdao Yier Pharmaceutical Co., Ltd. (China)

   • Expanding presence in opioid API manufacturing.
   • Complies with international standards, although buyer due diligence is required due to varying regulatory compliance.

Regulatory Considerations

• Manufacturing and shipment of oxycodone APIs are tightly regulated under the Controlled Substances Act (CSA) in the U.S. and similar regulations globally.
• Suppliers must possess appropriate DEA and international licensing, undergo rigorous audits, and comply with GMP.

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Aspirin API Sourcing

Major Global Suppliers

Aspirin, being a widely used NSAID, has a broader and more diverse supply chain compared to oxycodone.

1. BASF SE (Germany)

   • Largest global producer of acetylsalicylic acid, with high-purity manufacturing facilities.
   • Extensive supply chain, compliant with international pharmacopoeias.

2. Hubei Red Sun Pharmaceutical Co., Ltd. (China)

   • A significant supplier offering bulk aspirin APIs at competitive prices.

3. MeadWestvaco (USA)

   • Historically a major player in aspirin API, now integrated within larger chemical conglomerates.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

   • Offers pharmaceutical-grade aspirin API, compliant with GMP standards.

5. Sino Chemical Industry Co., Ltd. (China)

   • Supplies globally, with focus on quality and cost efficiency.

Regulatory and Quality Standards

• Aspirin API suppliers must meet the specifications outlined by the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other pharmacopeias.
• Manufacturing facilities should adhere to GMP, with quality assurance processes ensuring batch consistency, purity, and stability.

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Market Dynamics and Sourcing Trends

Global Supply Chain Considerations

• The opioid crisis and regulatory tightening have increased scrutiny on oxycodone API supply chains.
• Indian and Chinese suppliers dominate the opioid API market, driven by cost competitiveness and growing manufacturing capacity.
• Diversification of suppliers reduces risk and ensures compliance with international regulations.

Regulatory Challenges

• Stringent regulations and import controls influence sourcing strategies.
• Suppliers with established GMP certifications and good regulatory records are preferred.
• Supply chain disruptions, such as the COVID-19 pandemic, have accentuated the need for multiple reliable sources.

Cost Considerations

• Aspirin APIs are generally less expensive due to its widespread production and long-standing manufacturing processes.
• Oxycodone APIs, owing to their controlled status and complex synthesis, command higher prices and stricter procurement protocols.

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Key Sourcing Strategies for Pharmaceutical Companies

1. Horizontal Diversification

   • Engaging multiple API suppliers from different jurisdictions minimizes supply risk, ensures regulatory compliance, and secures competitive pricing.

2. Vendor Qualification and Auditing

   • Rigorous assessment of manufacturing facilities, quality systems, and regulatory compliance status.

3. Long-Term Supply Agreements

   • Establishing preferred supplier relationships to secure stable supply and price stability.

4. Traceability and Documentation

   • Ensuring complete traceability for regulatory submissions and compliance audits.

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Regulatory Considerations in API Procurement

• Controlled Substances Compliance: For oxycodone API, adherence to DEA regulations and licensing is mandatory.
• Good Manufacturing Practices (GMP): Critical for aspirin and oxycodone APIs to meet international standards.
• Quality Certifications: Suppliers should possess certifications from agencies like ISO, cGMP, and pharmacopoeial compliance.

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Conclusion

Sourcing high-quality API for Percodan demands meticulous evaluation of suppliers, especially given the controlled substance nature of oxycodone. While aspirin APIs are broadly available from diverse global suppliers, oxycodone APIs require partnerships with licensed, compliant manufacturers operating within regulated frameworks. The tightening regulatory environment and supply chain constraints emphasize the importance of strategic diversification and rigorous supplier qualification. Ensuring quality, compliance, and cost-effectiveness remains pivotal for pharmaceutical companies manufacturing Percodan and similar formulations.

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Key Takeaways

• Regulatory compliance is the cornerstone of sourcing APIs, especially controlled substances like oxycodone.
• Diverse supplier networks from North America, Europe, and Asia mitigate supply risks.
• GMP standards and certifications ensure quality and regulatory adherence.
• Market trends favor Indian and Chinese API producers for cost-effective sourcing, provided strict quality controls are maintained.
• Supply chain resilience requires strategic planning and long-term vendor relationships amid global regulatory evolution.

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FAQs

1. What are the primary concerns when sourcing oxycodone API for pharmaceutical manufacturing?
Regulatory compliance (DEA licensing, GMP adherence), supply chain reliability, quality assurance, and cost are key considerations. Controlled substance regulations impose strict licensing and auditing requirements.

2. Are there international suppliers capable of producing high-purity aspirin API?
Yes. Notably, BASF SE and Jiangsu Hengrui Medicine are prominent global producers known for high-quality, pharmacopeia-compliant aspirin APIs.

3. How does regulatory oversight impact API sourcing for controlled substances like oxycodone?
Regulations enforce licensing, manufacturing standards, and traceability, significantly restricting supplier options and increasing diligence and validation procedures.

4. Can Indian API manufacturers reliably supply oxycodone?
Many Indian companies, such as Sun Pharmaceutical Industries, possess the necessary licenses and GMP certifications to supply oxycodone APIs that comply with international standards.

5. How does market demand influence API pricing and sourcing strategies?
Higher demand for opioid APIs and regulatory restrictions elevate prices and necessitate diversified sourcing strategies to ensure supply continuity and regulatory compliance.

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Sources:
[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Supply Chain Security.
[2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP).
[3] IQVIA. Global API Market Insights.
[4] Bureau of Industry and Security (BIS). Export Controls for Controlled Substances.
[5] International Narcotics Control Board (INCB). Opioid Supply and Regulatory Policy.