Bulk Pharmaceutical API Sources for PROPOXYPHENE COMPOUND 65

Bulk Pharmaceutical API Sources for PROPOXYPHENE COMPOUND 65

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5216007
Sigma-Aldrich		C0750_SIAL
Sigma-Aldrich		C1778_SIAL
Sigma-Aldrich		C7731_SIAL
Sigma-Aldrich		C8960_SIAL

Bulk Active Pharmaceutical Ingredient (API) Sources for: PROPOXYPHENE COMPOUND 65

Last updated: July 30, 2025

Introduction

Propoxyphene, once widely used as an analgesic, is a synthetic opioid medication historically prescribed for mild to moderate pain relief. With its regulatory withdrawal in many countries due to safety concerns, sourcing its API—specifically the Propoxyphene Compound 65—has become increasingly niche and specialized. This article provides a comprehensive overview of current API sources, emphasizing regulatory considerations, manufacturing capabilities, and supply chain dynamics essential for pharmaceutical companies, compounding pharmacies, and research institutions.

Regulatory Context and Market Dynamics

Propoxyphene was withdrawn from the U.S. market in 2010 by the Food and Drug Administration (FDA) owing to its association with serious cardiovascular adverse effects and overdose risks [1]. Nonetheless, some countries continue to permit limited use, and academic or specialized suppliers may still produce and distribute Propoxyphene API for research or non-regulatory purposes. The ongoing demand hinges heavily on legal, regulatory, and safety frameworks. As a result, sourcing Propoxyphene API, particularly at the 'Compound 65' formulation, requires navigating an intricate landscape of compliance, manufacturing standards, and traceability.

Leading API Manufacturers and Suppliers

1. Major Global API Producers

The primary sources for Propoxyphene API historically stemmed from large-scale generic drug manufacturers and chemical intermediates suppliers. Many of these companies, especially in India and China, have the capability to produce opioid APIs in compliance with Good Manufacturing Practices (GMP). Notable among these are Sundia Corporation (China), Hainan Zenix Medichem (China), and APIs from India such as in some cases by Dr. Reddy’s Laboratories or Suven Life Sciences. These companies have previously supplied opioid APIs for research or export to markets where use is permitted.

2. Specialized Chemical and API Brokers

Because Propoxyphene API is now considered a controlled or discontinued substance in several jurisdictions, brokers specializing in vintage or niche APIs may facilitate procurement. These brokers often operate in compliance with applicable laws and may source from secondary or surplus inventories—though this requires rigorous due diligence to confirm legality and quality. Examples include ChemShuttle, Spectrum Chemical, and others that offer registered APIs for research or authorized uses.

3. Research-Grade API Suppliers

Some suppliers produce research-grade Propoxyphene for academic or laboratory studies. These are less likely to be GMP-certified but often available in small quantities for experimental purposes. Suppliers such as Abcam or Sigma-Aldrich may have limited offerings of related compounds but for Propoxyphene API, procurement generally involves specialized chemical catalogs or direct contact with chemical suppliers.

4. Contract Manufacturing Organizations (CMOs)

A limited number of CMOs capable of custom synthesis may produce Propoxyphene API under strict contractual and regulatory compliance, mainly for research or analytical reference standards. Companies like Pharmaron or Cambrex could, in principle, manufacture such APIs if bespoke orders are placed, assuming legal pathways are followed. Safety and legal compliance remain paramount, as opioid APIs are tightly regulated.

5. Regional and National Regulatory Agencies

In jurisdictions where Propoxyphene remains authorized, agencies such as the European Medicines Agency (EMA) or national regulatory bodies in Latin America and Asia might license ongoing production or import. Companies with approved manufacturing licenses are potential sources, but access is highly restricted and requires rigorous documentation.

Challenges in API Procurement

• Legal Restrictions: Due to safety and abuse potential, Propoxyphene APIs are often classified as controlled substances or discontinued. Procurement demands strict adherence to controlled substance laws, import/export regulations, and licensing requirements.
• Quality Assurance (QA) and Good Manufacturing Practices (GMP): Ensuring API quality involves verifying supplier GMP certification, certificate of analysis (CoA), and purity profiles. Non-compliance or counterfeit risks are significant concerns.
• Supply Chain Security: Given the decline in production and regulatory restrictions, supply chains are fragile. Establishing a secure, compliant, and traceable supply chain requires extensive due diligence.

Emerging Alternatives and Considerations

While sourcing Propoxyphene API remains complex, some companies explore alternative opioids or analgesic compounds with similar efficacy and safety profiles. Nonetheless, for specific research or legacy formulations, access to Propoxyphene Compound 65 API continues to be essential in certain niche applications.

Regulatory and Ethical Considerations

Procurement and use of Propoxyphene API must comply with international laws, including Controlled Substances Acts, Drug Enforcement Agency (DEA) regulations (in the U.S.), and equivalent authorities worldwide. This underscores the importance of licensed suppliers, comprehensive documentation, and legal clearance before acquisition and handling. Pharmaceutical companies and researchers must remain vigilant regarding the legal status of Propoxyphene in their respective jurisdictions.

Key Regulatory References

• FDA Withdrawal Notice (2010): Citing safety concerns [1].
• International Narcotics Control Board (INCB): Classifies opioids and controls related to supply and diversion.
• Local regulatory frameworks: Vary by country; often restrict or prohibit production, import, or use.

Conclusion

Securing bulk Propoxyphene Compound 65 API demands a nuanced understanding of worldwide regulatory frameworks, proven sourcing channels, and rigorous quality controls. While the supply landscape has contracted following regulatory actions, select niche suppliers, brokers, and research-grade providers continue to service legitimate needs within compliant boundaries. Organizations must prioritize due diligence, legal compliance, and safety when navigating this specialized market.

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Key Takeaways

• The availability of Propoxyphene API is limited and heavily regulated, primarily used for research or historical purposes.
• Leading sources include GMP-certified Chinese and Indian API manufacturers, brokers specializing in vintage APIs, and research suppliers with regulated standards.
• Navigating legal restrictions is paramount; procurement must align with local and international controlled substance laws.
• Due diligence in quality assurance, traceability, and regulatory compliance mitigates risks associated with sourcing APIs of this nature.
• Organizations should consider alternative analgesics if regulatory hurdles outweigh benefits of procuring Propoxyphene API.

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FAQs

Q1: Is it legal to purchase Propoxyphene API for research purposes?
A: Legality depends on jurisdiction. In many countries, Propoxyphene is classified as a controlled substance or has been discontinued, limiting legal procurement to licensed organizations for research under strict regulatory oversight.

Q2: What are the primary countries producing Propoxyphene API today?
A: China and India historically supplied Propoxyphene API. However, current production is restricted, and supplies are primarily from secondary markets or specialized brokers complying with applicable laws.

Q3: How do I verify the quality of Propoxyphene API from suppliers?
A: Request Certificates of Analysis (CoA), GMP certification, purity profiles, and confirm that the supplier complies with relevant standards (e.g., ICH, USP). Third-party testing can further validate quality.

Q4: Are there alternatives to Propoxyphene for analgesic research?
A: Yes, FDA-approved alternatives include acetaminophen, NSAIDs, or other opioids like tramadol. For specific research needs, consult pharmacological experts regarding suitable substitutes.

Q5: What are the risks associated with sourcing Propoxyphene API?
A: Risks include legal violations, supply variability, counterfeit products, and safety hazards due to the compound’s narrow therapeutic margin and toxicity. Engaging licensed and reputable suppliers mitigates these risks.

References

[1] U.S. FDA. (2010). "FDA Requests Removal of Propoxyphene from Market."
[2] International Narcotics Control Board. (2022). "Obligations with Respect to Opioids."
[3] European Medicines Agency. (2010). "Assessment Report on Withdrawal of Propoxyphene."