Bulk Pharmaceutical API Sources for PROPOXYPHENE COMPOUND-65

Bulk Pharmaceutical API Sources for PROPOXYPHENE COMPOUND-65

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		Hg|d@Dq]@\bbbbfJSSimUSTs@@
ChemBridge		5216007
Sigma-Aldrich		C0750_SIAL
Sigma-Aldrich		C1778_SIAL
Sigma-Aldrich		C7731_SIAL

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

Last updated: August 8, 2025

Introduction

Propoxypene Compound-65, a synthetic opioid analgesic, plays a crucial role in pain management protocols. As pharmaceutical companies and compounding facilities seek reliable sources for this API, understanding the global landscape of suppliers, regulatory considerations, and market dynamics becomes essential. This article provides a comprehensive overview of bulk API sources for Propoxypene Compound-65, analyzing key manufacturers, sourcing strategies, and compliance factors relevant to industry stakeholders.

---

Overview of Propoxypene Compound-65

Propoxypene, a derivative within the opioid class, functions primarily as a potent analgesic. Its synthesis involves complex chemical pathways, demanding high purity standards. The API’s controlled status under various regulatory bodies—primarily due to its psychoactive properties—necessitates adherence to strict manufacturing and sourcing guidelines. The compound's nomenclature, "Compound-65," indicates specific structural or patent designations, often linked to proprietary formulations or patents.

---

Global API Suppliers for Propoxypene Compound-65

1. Major Domestic and International Manufacturers

The supply chain for Propoxypene Compound-65 is concentrated among select pharmaceutical chemical manufacturers equipped with advanced synthesis capabilities. Leading entities include:

• Global Chemical Suppliers in China and India
  China dominates the API manufacturing sector, with numerous GMP-compliant facilities producing opioids with significant capacities. Companies like Zhejiang Haishen Pharmaceutical Co. and TPI (The Pharmaceutical Ingredients Co.) have established expertise in controlled substances, including opioids, with multi-ton production capabilities. Similarly, Indian firms like GVK Biosciences and Sun Pharmaceutical Industries have expanded their portfolios to include complex APIs such as Propoxypene Compound-65, leveraging cost advantages and robust supply chains.

• European and US-Based Manufacturers
  While regulatory restrictions limit the direct import of controlled substances into markets like the US and Europe, several certified manufacturers provide high-purity APIs to licensed pharmaceutical companies. Notable firms include Catalent Pharma Solutions and Piramal Pharma Solutions, which supply APIs to authorized entities under strict compliance.

2. Contract Manufacturing Organizations (CMOs)

CMOs specializing in opiate synthesis and controlled substances are significant sources for bulk API procurement. These organizations often operate under robust regulatory frameworks like the US DEA (Drug Enforcement Administration) and the European Medicines Agency (EMA), ensuring supply chain integrity. Examples include:

• Hikma Pharmaceuticals
  Known for its controlled substance manufacturing capabilities, Hikma offers custom synthesis and supply options for APIs like Propoxypene, primarily catering to licensed pharmaceutical firms.

• Norwood Pharmacal
  A U.S.-based CMO with DEA registration, capable of producing high-purity opioids within regulatory standards.

3. Proprietary and Patent-Holding Manufacturers

Some pharmaceutical companies hold patents or exclusive manufacturing rights for Propoxypene Compound-65, acting as primary API sources:

• AbbVie Inc. (or affiliate entities)
  Historically involved in opioid synthesis, some of their formulations might be licensed or licensed-to-distribute.

• Mallinckrodt Pharmaceuticals
  Active in opioid production, possessing GMP-certified facilities compliant with regulatory standards.

---

Sourcing Strategies and Considerations

1. Regulatory Compliance and Licensing

Given Propoxypene Compound-65's status as a controlled substance, sourcing only occurs with valid licenses. Manufacturers and purchasers must adhere to:

• DEA Registration (U.S.) or equivalent authorities (e.g., the European Monitoring Centre for Drugs and Drug Addiction - EMCDDA)
• Good Manufacturing Practices (GMP) certification
• Secure supply chain documentation and batch traceability

2. Quality Standards

APIs must meet stringent purity criteria (typically 99% or higher) and conform to pharmacopoeial standards (USP, EP, or JP). Quality assurance includes:

• Extensive analytical testing (HPLC, GC-MS, etc.)
• Certificates of Analysis (COA)
• Stability testing and impurity profiling

3. Navigating Market and Supply Risks

Supply chain risks include:

• Regulatory crackdowns restricting controlled substances
• Manufacturing delays due to compliance issues or capacity constraints
• Price fluctuations driven by geopolitical factors and demand-supply dynamics

Developing partnerships with multiple reliable suppliers and verifying their compliance credentials mitigates these risks.

---

Emerging Trends and Future Outlook

The global API market for opioids like Propoxypene Compound-65 is subject to evolving regulatory landscapes emphasizing controlled substance monitoring.

• Shift towards transparency and traceability: Blockchain and digital ledger technologies are increasingly employed to ensure supply chain integrity.
• Increased enforcement against illicit manufacturing: Stricter controls and seizures have impacted legitimate supply channels, compelling licensed purchasers to develop resilient sourcing strategies.
• Innovation in synthetic routes: Advances in chemical synthesis aim to improve yield, reduce costs, and enhance safety.

As demand persists for legitimate medical use, authorized sources continue to expand their capabilities, with governments investing in secure manufacturing infrastructure.

---

Conclusion

Reliable bulk sources for Propoxypene Compound-65 are primarily concentrated among GMP-compliant manufacturers in China, India, Europe, and the United States. Sourcing strategies must prioritize regulatory compliance, quality assurance, and supply chain security. Industry stakeholders should cultivate relationships with licensed, reputable manufacturers and incorporate technological solutions to mitigate risks associated with controlled substance procurement.

---

Key Takeaways

• Propoxypene Compound-65 is sourced from a limited number of GMP-compliant manufacturers mainly across China, India, Europe, and the US.
• Strict regulatory adherence (DEA licensing, GMP certification) is mandatory for procurement.
• Quality standards, including high purity and traceability, are essential for supplier qualification.
• Contract manufacturing organizations (CMOs) play a key role in providing reliable supply amid regulatory challenges.
• Emerging technological solutions and market trends aim to enhance transparency and supply chain integrity.

---

FAQs

1. What are the primary regulatory considerations when sourcing Propoxypene Compound-65?
Procurement requires proper licensing under DEA or equivalent authorities, adherence to GMP standards, rigorous documentation, and compliance with international controlled substance regulations.

2. Which countries dominate the manufacturing of Propoxypene Compound-65?
China and India host most manufacturing facilities due to their large-scale chemical synthesis capabilities. Europe and the US mainly act as consumers or regulated supply points.

3. How can companies verify the quality of API suppliers for Propoxypene Compound-65?
Through Certificates of Analysis, third-party audits, GMP certification validation, and batch testing to confirm purity and compliance with pharmacopoeial standards.

4. Are there alternative sources or synthetic routes for Propoxypene Compound-65?
While current supply relies on established manufacturers, research into synthetic pathways aims to optimize production and potentially diversify sourcing options, subject to regulatory approval.

5. What challenges face the supply chain of Propoxypene Compound-65?
Regulatory restrictions, enforcement actions against illicit manufacturing, geopolitical issues, and capacity limitations pose ongoing risks to secure sourcing.

---

Sources
[1] U.S. Drug Enforcement Administration (DEA) Controlled Substances Import and Export, 2022.
[2] European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).
[3] Global Pharmaceutical Chemical Suppliers Directory, 2023.
[4] Industry Reports on Global Opioid API Markets, 2022.
[5] GMP Compliance Guidelines, WHO, 2021.