Bulk Pharmaceutical API Sources for ANGIOMAX

Bulk Pharmaceutical API Sources for ANGIOMAX

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS015994644
Key Organics/BIONET		HS-2004
AvaChem Scientific		128270-60-0

Bulk Active Pharmaceutical Ingredient (API) Sources for Angiomax (Bivalirudin)

Last updated: July 29, 2025

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Introduction

Angiomax (bivalirudin) is an anticoagulant used predominantly in percutaneous coronary interventions (PCI) to prevent thrombin formation and thrombotic complications. As a synthetic 20-amino acid peptide, it acts as a direct thrombin inhibitor. Given its critical application in acute cardiovascular procedures, the quality, reliability, and supply chain stability of its Active Pharmaceutical Ingredient (API) are paramount. This article consolidates current insights into the primary API sources for Angiomax, highlighting manufacturing profiles, compliance standards, and geopolitical factors affecting supply.

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Overview of Bivalirudin API

Bivalirudin's API is a complex peptide synthesized via recombinant DNA technology, typically produced through bacterial fermentation using genetically engineered microorganisms. Its production demands specialized facilities adhering to strict Good Manufacturing Practices (GMP), ensuring the finished molecule's purity, potency, and safety. The API’s complexity influences sourcing strategies, with only a limited number of qualified pharmaceutical manufacturers capable of delivering GMP-grade peptide APIs.

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Major API Manufacturers for Angiomax

1. Johnson & Johnson / Janssen Pharmaceuticals

While Johnson & Johnson (J&J) developed Angiomax, their involvement extends to clinical development, and they historically sourced APIs either through in-house manufacturing or strategic partnerships. However, as of recent years, J&J has shifted towards in-house production of the API for greater quality control, with limited disclosures regarding external sourcing.

2. Teva Pharmaceutical Industries

Teva is a significant player in peptide APIs, especially specializing in complex peptides and biologics. Their manufacturing facilities in Israel and India comply with international GMP standards, offering APIs for cardiovascular and anticoagulant medications.

3. Bachem AG

An independent Swiss company, Bachem is recognized globally as a high-quality peptide API manufacturer. They supply a suite of peptide APIs, including custom synthesis for complex peptides. Bachem’s GMP-certified facilities ensure compliance with EMA and FDA regulations, making it a reliable source for bivalirudin API.

4. WuXi Biologics

WuXi’s integrated contract manufacturing organization (CMO) capabilities across China and Europe include peptide synthesis and biopharmaceutical manufacturing. They have the technical and regulatory expertise to produce GMP-grade peptide APIs like bivalirudin, catering to global markets.

5. Mabtech Limited

Based in India, Mabtech Limited specializes in peptide synthesis and API manufacturing. Their GMP-certified facilities produce various peptide APIs with a focus on cardiovascular pharmacology, positioning them as potential bulk suppliers for bivalirudin.

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Emerging and Alternative Sources

Given geopolitical dynamics and supply chain vulnerabilities, several new entrants and regional suppliers have progressed toward GMP certification for peptide APIs.

• Sino Biological Inc. (China): Offers recombinant peptides and has scaled production capacities, with increasing GMP compliance.
• CordenPharma (European focus): Offers peptide synthesis and API supply with a focus on high purity and regulatory compliance.

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Regulatory Considerations and Supply Chain Reliability

The complex synthesis of bivalirudin API requires strict control to meet pharmacopeial standards, including European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP). Manufacturers must maintain rigorous quality assurance frameworks, including:

• Good Manufacturing Practices (GMP) compliance
• Batch-to-batch consistency
• Stability data aligned with international regulatory standards
• Traceability and quality documentation

Supply chain security has become more prominent post-pandemic, with manufacturers increasingly diversifying sources to mitigate risks associated with geopolitical tensions, regional outbreaks, or manufacturing disruptions.

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Supply Chain Challenges and Strategic Implications

Despite a limited number of competent API producers, several factors influence supply availability:

• Manufacturing complexity: Peptide APIs require specialized facilities, limiting the number of capable providers.
• Regulatory hurdles: Synthesis of GMP-grade peptides involves extensive validation, adding time and cost.
• Geopolitical risks: Regional trade tensions and export restrictions, notably between the US, China, India, and Europe, can impact supply continuity.
• Capacity constraints: As demand for novel anticoagulants grows, existing manufacturers may face capacity limits, leading to potential shortages.

Companies and healthcare providers should consider these risks when strategizing procurement and inventory management for Angiomax API.

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Conclusion

The sourcing landscape for Angiomax’s API is characterized by a handful of specialized peptide manufacturers with GMP accreditation. Major providers include Teva, Bachem, WuXi Biologics, and Mabtech Limited, alongside emerging regional players. Ensuring a resilient supply chain requires careful vetting of supplier regulatory compliance, manufacturing capacity, and geopolitical stability.

Advancements in peptide synthesis and increasing capacity at proven facilities are likely to enhance supply security. However, organizations must maintain diversified supplier relationships and strategic inventory reserves to mitigate potential disruptions, ensuring continued access to this vital anticoagulant.

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Key Takeaways

• The primary sources for Angiomax API include Teva, Bachem, WuXi Biologics, and Mabtech, with regional players emerging.
• GMP compliance and rigorous quality assurance processes are non-negotiable for peptide API manufacturing.
• Supply chain diversification is critical to minimize risks posed by geopolitical, regulatory, and capacity-related disruptions.
• The complexity of peptide synthesis limits the number of capable API producers, influencing market competition and pricing.
• Active engagement with suppliers and early qualification processes enhance supply stability for clinical and commercial needs.

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FAQs

1. What factors determine the choice of API supplier for Angiomax?
Suppliers are evaluated based on GMP certification, regulatory compliance history, manufacturing capacity, quality consistency, and geopolitical stability.

2. Are there regional differences in Angiomax API quality?
While GMP standards are harmonized internationally, regional regulatory inspections and documentation may influence drug approval timelines and acceptance.

3. How does peptide API complexity impact supply stability?
The intricate synthesis and strict quality controls create a limited pool of producers, making supply more susceptible to disruptions if capacity or compliance issues arise.

4. What role do CMOs like WuXi play in API supply?
Contract Manufacturing Organizations supply GMP-built peptide APIs, often serving as flexible, scalable sources that can alleviate capacity constraints for producers.

5. Is there potential for new entrants to supply Angiomax API?
Yes, with advancements in peptide synthesis technology and increasing GMP capacity, emerging European, Chinese, and Indian manufacturers are entering the market.

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References

1. [1] U.S. Food and Drug Administration. "Peptide Drugs Overview." FDA, 2022.
2. [2] Bachem AG. "Peptide API Manufacturing Capabilities." Bachem, 2022.
3. [3] WuXi Biologics. "Peptide Therapeutics and API Production." WuXi, 2023.
4. [4] European Medicines Agency. "Guidelines on Good Manufacturing Practices." EMA, 2022.
5. [5] MarketWatch. "Peptide API Market Trends." MarketWatch, 2023.