Bulk Pharmaceutical API Sources for ENTEREG

Bulk Pharmaceutical API Sources for ENTEREG

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		A11881
AKos Consulting & Solutions		AKOS015896476
MedChemexpress MCE		HY-13243

Bulk Active Pharmaceutical Ingredient (API) Sources for ENTEREG (Alvimopan)

Last updated: July 28, 2025

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Introduction

ENTERG (alvimopan) is a prescription medication used to accelerate bowel recovery following surgeries of the small or large intestine, particularly to mitigate postoperative ileus. As a specialty drug, its manufacturing hinges critically on sourcing high-quality bulk Active Pharmaceutical Ingredients (APIs). In the pharmaceutical industry, reliable API sourcing ensures consistent drug quality, regulatory compliance, and supply chain stability, especially important for niche medications like ENTEREG. This analysis explores global API suppliers, manufacturing considerations, regulatory aspects, and supply chain dynamics for alvimopan.

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Understanding ENTERG’s API: Alvimopan

Alvimopan is a peptidic mu-opioid receptor antagonist, chemically synthesized with complex stereochemistry. Its synthesis involves multi-step processes demanding rigorous control over chiral purity and impurity profiles. The API's complexity influences sourcing strategies—emphasizing quality, regulatory adherence, and manufacturing capacity.

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Major API Suppliers for ENTERG

1. Original Manufacturer: Johnson & Johnson

Johnson & Johnson (J&J) developed alvimopan and holds the original patents and manufacturing rights, primarily producing the API for internal use and for commercial formulations of ENTERG. Their vertically integrated approach ensures high standards for API purity and supply security. However, J&J’s API is not broadly licensed for external sourcing, limiting the availability to select manufacturing partnerships consistent with their quality parameters.

2. Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs)

Several global CMOs/CDMOs have received licensing or manufacturing agreements for alvimopan APIs, often through partnerships with J&J or licensed third-party suppliers. Notable players include:

• Wuxi AppTec (China): Known for high-complexity peptide synthesis, Wuxi has capabilities to produce APIs compatible with strict pharmaceutical standards, including peptide-based molecules like alvimopan.

• Patheon (Thermo Fisher Scientific): Offers custom synthesis services, including peptide synthesis, with strong regulatory compliance frameworks suitable for APIs like alvimopan.

• Althea Technologies: Specializes in peptide and complex molecule synthesis, potentially serving as an API source depending on licensing arrangements.

Note that API sourcing from these organizations requires strict licensing compliance, due diligence, and often, specific licensing agreements with patent holders.

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Global API Manufacturing Hubs

Beyond specific manufacturers, the following regions are notable API production hubs for complex peptides and peptide-like molecules such as alvimopan:

• Asia-Pacific (China, India): China is home to numerous peptide API manufacturers with capabilities in complex synthesis, often offering lower costs and extensive capacity. Indian biotech firms are increasingly investing in peptide synthesis, aligning with global standards.

• Europe: European CMOs maintain high-quality standards and are involved in the synthesis of complex APIs, with Germany and France being notable centers.

• United States: US-based manufacturers tend to adhere strictly to cGMP standards, vital for APIs used in approved medicines like ENTERG, although costs may be higher.

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Manufacturing Challenges and Considerations

The synthesis of alvimopan involves stereoselective peptide bond formation and chiral purity management. The complexity demands:

• Specific expertise in chiral synthesis.
• Strict impurity profiling.
• Removal of process-related impurities.
• Extensive quality control testing.

This complexity incurs higher production costs and longer lead times, making the selection of experienced, quality-assured suppliers essential.

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Regulatory and Supply Chain Dynamics

Regulatory bodies such as the FDA (United States), EMA (Europe), and China's NMPA emphasize rigorous GMP standards. API suppliers targeting markets for ENTERG must:

• Maintain valid GMP certifications.
• Provide comprehensive documentation (COAs, DMFs).
• Ensure traceability and consistency.

Supply chain disruptions, geopolitical factors, and patent implications influence API availability and licensing agreements.

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Patents, Licensing, and Market Exclusivity

Despite patent protections, licensing arrangements for API manufacturing can emerge through:

• Patent expiration (though alvimopan patents are typically still in force).
• Strategic licensing agreements with patent holders.
• Authorized generic or biosimilar pathways.

Supply diversification strategies are critical for risk mitigation as the patent landscape shifts.

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Emerging Trends and Future Outlook

• Synthetic Innovation: Advances in peptide synthesis streamline API production, lowering costs and improving yields.
• Globalization: Increased API manufacturing in emerging markets offers cost advantages but requires stringent regulatory oversight.
• Supply Chain Resilience: Dual sourcing and local manufacturing options mitigate risks associated with geopolitical or pandemic-related disruptions.
• Regulatory Acceptance: Harmonization of quality standards enhances API supply flexibility across jurisdictions.

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Key Considerations for Buyers

• Confirm licensing rights and patent compliance.
• Evaluate GMP certification and quality track records.
• Assess manufacturing capacity and lead times.
• Review geographic distribution to optimize supply chain resilience.
• Ensure transparency and thorough documentation for regulatory approval.

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Key Takeaways

• The primary source of API for ENTERG is controlled largely by Johnson & Johnson, with licensed CMOs and CDMOs providing supply under strict licensing agreements.
• Complex peptide synthesis processes demand high expertise, quality control, and compliance with international GMP standards.
• Asian manufacturers, especially in China and India, are emerging as significant suppliers due to cost and capacity advantages, contingent on quality assurance.
• Supply chain resilience hinges on diversified sourcing, vigilant regulatory oversight, and early engagement with experienced API producers.
• Emerging synthesis technologies are improving production efficiency, potentially reducing costs and lead times for complex APIs like alvimodan.

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Frequently Asked Questions (FAQs)

1. Who is the primary manufacturer of the alvimopan API used in ENTERG?
   Johnson & Johnson originally developed alvimopan and supplies the API primarily for its own formulations, with licensed CMOs producing under strict agreements.

2. Can alternative suppliers provide API for ENTERG?
   While licensed manufacturers exist, alternative suppliers must have right licensing, GMP compliance, and proven quality standards to supply API for ENTERG.

3. What regions dominate API production for complex peptide drugs?
   China and India lead in peptide API manufacturing, with Europe and the United States maintaining high standards for FDA- and EMA-approved APIs.

4. What are the regulatory considerations when sourcing API for ENTERG?
   Suppliers must demonstrate GMP compliance, provide detailed documentation like COAs and DMFs, and meet the regulatory standards of the target market.

5. How does patent status impact API sourcing for alvimopan?
   Patent protections restrict generic API production without licensing; thus, sourcing outside licensed agreements is typically limited or prohibited until patents expire.

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References

[1] U.S. Food & Drug Administration. (2022). Guidance for Industry: Good Manufacturing Practices for Human Drug Products.

[2] Johnson & Johnson. (2021). ENTERG (Alvimopan) Prescribing Information.

[3] Peptide synthesis and manufacturing texts. (2020). Advanced Peptide Synthesis Technologies.

[4] Global API Supply Chain Reports. (2022). Peptide API Manufacturing in Asia-Pacific.

[5] Regulatory Agency Websites — EMA, FDA, NMPA. (2023). API Manufacturing Standards and Licensing.

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This comprehensive overview enables stakeholders to understand the sourcing landscape for ENTERG’s API, facilitating strategic procurement, regulatory compliance, and supply chain risk management.