Suppliers and packagers for ANGIOMAX

ANGIOMAX

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873	NDA AUTHORIZED GENERIC	Civica, Inc.	72572-035-10	10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)	2020-12-21
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873	NDA AUTHORIZED GENERIC	Pharma Packaging Solutions, LLC dba Tjoapack LLC	75929-217-01	10 VIAL, SINGLE-USE in 1 CARTON (75929-217-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE	2020-12-21

Suppliers for the Pharmaceutical Drug: Angiomax (Bivalirudin)

Last updated: July 30, 2025

Introduction

Angiomax (generic name: bivalirudin) is a synthetic anticoagulant used primarily in percutaneous coronary interventions (PCI) and other cardiovascular procedures, where rapid and effective blood thinning is critical. Approved by the U.S. Food and Drug Administration (FDA) in 2000, Angiomax is marketed by The Medicines Company, now part of Novartis after its acquisition in 2020. Given its complexity as a biologically derived peptide, the supply chain for Angiomax involves specialized manufacturing processes, rigorous quality controls, and a limited pool of high-caliber suppliers.

This article explores the key suppliers involved in the production and supply chain of Angiomax, analyzing manufacturing sources, raw material providers, and distribution channels. Understanding these elements is vital for stakeholders involved in procurement, strategic planning, and supply chain management within the pharmaceutical ecosystem.

Manufacturing of Bivalirudin: The Core Supplier Role

Synthetic Peptide Synthesis

Bivalirudin is a synthetic peptide, comprising 20 amino acids, designed to mimic the natural thrombin-inhibiting effects. Its complex synthesis involves solid-phase peptide synthesis (SPPS) techniques, requiring high-purity reagents, peptide syntheses expertise, and stringent quality controls. This segment is dominated by a select number of specialized chemical manufacturing companies that produce active pharmaceutical ingredients (APIs) for peptide drugs.

Key API Suppliers

While the specific manufacturers of bivalirudin’s active pharmaceutical ingredient are not publicly disclosed due to proprietary reasons, several global firms are recognized for their capabilities in peptide synthesis at an industrial scale:

• Bachem: A Swiss based firm specializing in custom peptide synthesis, including complex APIs forInjectable drugs. Bachem supplies peptides to pharmaceutical companies globally, leveraging robust manufacturing facilities compliant with Good Manufacturing Practice (GMP) standards.

• LKT Laboratories: An American company offering a wide range of peptides and amino acids, with capabilities for GMP manufacturing. Their involvement includes custom peptide synthesis, occasionally supplying APIs for collaborations in cardiovascular drugs.

• Pepticom: An Israel-based biotech providing peptide synthesis and therapeutic development services. While mainly focused on research, Pepticom’s scalable synthesis facilities are capable of supporting production needs for peptide-based drugs.

• Aspen Neurosciences and Polypeptide Laboratories: These companies offer GMP manufacturing of peptide APIs, including cGMP-grade peptides suitable for injectable drugs. Their processes adhere to strict regulatory standards, ensuring safety and efficacy.

Raw Material Suppliers

The peptide synthesis process necessitates high-quality raw materials, primarily amino acids with specific stereochemistry, protecting groups, coupling agents, solvents, and catalysts. Major raw material suppliers include:

• Evonik Industries: Supplies specialty chemicals, including amino acids used as building blocks in peptide synthesis.

• Ajinomoto: A global leader in amino acids, offering high-quality, pharmaceutically pure raw materials fundamental to peptide manufacture.

• Cambridge Commodities: Provides a range of amino acids and peptide synthesis reagents from GMP-compliant sources, supporting pharmaceutical API production.

Manufacturing Facilities and Quality Assurance

Manufacturing of bivalirudin must meet international GMP standards, with strict quality assurance to prevent contamination and ensure consistent potency. Major contract manufacturing organizations (CMOs) with GMP-approved facilities capable of peptide API production include:

• Lonza: Known for biopharmaceutical manufacturing, Lonza offers peptide synthesis services complying with regulatory standards, with proven track records in producing complex peptide APIs.

• Samsung Biologics: A major player in biologics manufacturing, with capabilities extending to peptide APIs, offering scalable manufacturing and robust quality management systems.

• Boehringer Ingelheim: Engaged in peptide manufacturing with extensive experience in GMP facilities supporting injectable peptide APIs.

Formulation and Final Drug Manufacturing

Following API production, Angiomax’s formulation involves blending with excipients and sterilization processes. The final drug manufacturing occurs in specialized sterile facilities, often managed by the original marketing companies or licensed third-party manufacturers with expertise in injectable formulations.

Distribution and Logistics

Angiomax is supplied in pre-filled syringes or vials, requiring cold chain logistics to maintain drug stability. Distribution channels include:

• Authorized Distributors and Wholesalers: These entities distribute Angiomax to hospitals, clinics, and pharmacies globally, with logistics networks to ensure temperature control and rapid delivery.

• Direct Supply Agreements: Some healthcare systems procure directly from manufacturers or authorized agents, especially in regions with centralized procurement policies.

Regulatory Considerations and Supply Chain Risks

Given the critical nature of Angiomax, its supply chain faces constraints stemming from:

• Limited Raw Material Suppliers: The complexity of peptide synthesis restricts the number of reliable raw material suppliers, risking supply shortages during high demand or supply disruptions.

• Manufacturing Capacity Constraints: The specialized nature of peptide APIs limits manufacturing scalability, which may be challenged during global health crises or increased demand.

• Regulatory Barriers: Variations in GMP standards across regions influence supplier options, requiring manufacturers to maintain strict compliance to access international markets.

Key Players in the Angiomax Supply Chain

Segment	Major Entities	Roles
Raw Material Suppliers	Ajinomoto, Evonik Industries	Supply of amino acids and reagents
API Manufacturers	Bachem, Lonza, Pepticom	Synthesis of bivalirudin API
Final Formulation	Contract manufacturers (e.g., Boehringer Ingelheim)	Formulation and sterile filling
Distribution	Authorized wholesalers, healthcare systems	Logistics, cold chain management

Conclusion

The supply chain for Angiomax hinges on a finely tuned network of specialized peptide API producers, raw material suppliers, and distribution channels, each playing a vital role in ensuring drug availability. While a limited pool of high-caliber manufacturers and raw material sources sustains the process, ongoing supply chain risks necessitate strategic partnerships, diversified sourcing, and robust quality management. Monitoring regulatory developments and maintaining flexibility in manufacturing capacities are essential for sustained supply and market resilience.

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Key Takeaways

• Limited API Producers: Peptide synthesis for Angiomax is conducted by a handful of GMP-compliant firms, primarily in Europe and North America, making supply chain resilience crucial.

• Raw Material Dependency: High-quality amino acids from companies like Ajinomoto and Evonik underpin API production, with potential vulnerabilities if supply chains are disrupted.

• Manufacturing and Quality Control: Global contract manufacturers operating GMP facilities ensure consistent, regulatory-compliant production, yet capacity constraints persist amid growing demand.

• Distribution Challenges: Cold chain logistics are vital for maintaining drug efficacy during transit, requiring well-established global logistics networks.

• Strategic Sourcing is Essential: Diversification of raw material and contract manufacturing sources minimizes risk and ensures continuous supply.

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FAQs

1. Who are the primary manufacturers of the bivalirudin API?
   While proprietary confidentiality limits full disclosure, firms like Bachem, Lonza, and Pepticom are recognized for their peptide synthesis capabilities in producing APIs like bivalirudin under GMP standards.

2. What raw materials are critical for Angiomax production?
   High-purity amino acids, including L- and D- amino acids, used as building blocks in peptide synthesis, supplied by companies such as Ajinomoto and Evonik.

3. Are there alternative suppliers or synthesis methods for bivalirudin?
   Currently, production relies on complex solid-phase peptide synthesis. Alternate suppliers are limited due to the specialized nature of API manufacturing, emphasizing the importance of supply chain diversification.

4. What supply chain risks threaten Angiomax availability?
   Risks include raw material shortages, capacity constraints at peptide manufacturers, logistical challenges in cold chain distribution, and regulatory hurdles in different regions.

5. How do regulatory standards affect the supply chain of Angiomax?
   Compliance with GMP standards across manufacturing stages ensures safety and efficacy but constrains sourcing options, necessitating ongoing validation and audits of suppliers and facilities.

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References:

1. The Medicines Company. (2000). Angiomax (bivalirudin) prescribing information.
2. FDA. (2020). Bivalirudin approval documentation.
3. Bachem AG. (2022). Corporate capabilities and GMP peptide synthesis services.
4. Lonza Group. (2022). Peptide API manufacturing processes and standards.
5. Ajinomoto Co., Inc. (2022). High-quality amino acids for pharmaceutical synthesis.