Bulk Pharmaceutical API Sources for EPTIFIBATIDE

Bulk Pharmaceutical API Sources for EPTIFIBATIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-069-141
Amadis Chemical		A808724
Amadis Chemical		A813250

Last updated: July 29, 2025

lk Active Pharmaceutical Ingredient (API) Sources for Eptifibatide

Introduction
Eptifibatide, marketed under the brand name Integrilin, is a potent antiplatelet agent used primarily for the prevention of thrombotic cardiovascular events in acute coronary syndromes and during percutaneous coronary interventions (PCI). As a cyclic heptapeptide with a unique RGD (arginine-glycine-aspartic acid) motif, eptifibatide functions as a glycoprotein IIb/IIIa receptor antagonist, inhibiting platelet aggregation. Given its critical therapeutic role, reliable sourcing of bulk API is essential for pharmaceutical manufacturers. This article explores the global landscape of API manufacturers providing bulk eptifibatide, highlighting key suppliers, manufacturing considerations, and industry trends facilitating quality and supply stability.

Market Overview and Regulatory Context
The procurement of eptifibatide APIs involves navigating complex regulatory terrains governed by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities. Manufacturers must comply with Good Manufacturing Practices (GMP), emphasizing purity, consistency, and traceability. The market for eptifibatide APIs is concentrated among specialized peptide producers capable of complex synthesis, precise stereochemical control, and rigorous quality assurance.

Key API Manufacturers for Eptifibatide

1. Bachem AG

Overview
Bachem, headquartered in Switzerland, is a leading manufacturer of custom peptides and APIs, including complex cyclic peptides similar to eptifibatide. They have extensive expertise in peptide synthesis, scaling from research to commercial production, ensuring high purity and quality.

Capabilities

• Large-scale GMP production of cyclic peptides
• Custom synthesis specializing in RGD-motif peptides
• Robust quality management systems aligning with international standards

Relevance to Eptifibatide
While Bachem primarily supplies custom peptides, its capabilities facilitate the development of eptifibatide API, aligning with pharmaceutical companies’ needs for reliable, high-quality bulk peptides for APIs.

2. Polypeptide Group (China)

Overview
The Polypeptide Group, based in China, specializes in peptide synthesis and GMP manufacturing, expanding its portfolio to include complex therapeutic peptides. It boasts significant production capacity and cost competitiveness.

Capabilities

• GMP-compliant peptide synthesis for clinical and commercial phases
• Expertise in cyclic peptides similar in structure to eptifibatide
• Diversified supplier base catering to global pharmaceutical markets

Relevance to Eptifibatide
The firm's experience with RGD-containing peptides positions it as a notable supplier or producer partner for bulk eptifibatide API, especially for global markets requiring cost-effective sourcing.

3. Khusyr LLC (Russia)

Overview
Khusyr specializes in peptide manufacturing with particular focus on specialty peptides and APIs for cardiovascular indications. Their facilities meet ISO GMP standards suitable for producing active pharmaceutical ingredients.

Capabilities

• Custom peptide synthesis with high purity standards
• Manufacturing of GMP-grade cyclic peptides
• Focus on peptides with pharmacological relevance to thrombosis

Relevance to Eptifibatide
Their technological infrastructure supports production of eptifibatide-like cyclic peptides, potentially serving as API suppliers for regionally focused pharmaceutical companies.

4. Thermo Fisher Scientific

Overview
While primarily a biotech supplier, Thermo Fisher offers peptide synthesis services that include GMP-grade peptides suitable for API manufacturing. Their scalable processes and quality assurance systems lend credibility to supply chains.

Capabilities

• Custom synthesis of peptides suitable for API production
• GMP manufacturing infrastructure worldwide
• Extensive analytical and quality control support

Relevance to Eptifibatide
Thermo Fisher’s global network can support pharmaceutical companies seeking reliable peptide synthesis to produce eptifibatide API or its intermediates.

5. Small Peptide Contract Manufacturing Organizations (CMOs)

Several smaller CMOs worldwide specialize in peptide API manufacturing, often collaborating with larger pharma companies or offering contract development services. These include entities in India, South Korea, and Europe, with capabilities to synthesize cyclic and complex peptides under GMP conditions. Examples include:

• Biosynth Carbosynth (UK)
• Devro Pharmacals (India)
• Jiangsu Hengrui Medicine Co., Ltd. (China)

Their role mainly involves custom synthesis, scale-up, and validation prior to commercial API production.

Industry Trends and Challenges in Sourcing Eptifibatide API

• Emerging Biosynthetic Methods: Advanced recombinant or biosynthetic methods are increasingly explored to reduce synthesis costs and improve scalability, although peptide synthesis remains dominant for eptifibatide.
• Regional Supply Concentration: Currently, most API sourcing is concentrated in Asia and Europe, emphasizing the importance of diversified supplier networks to mitigate supply chain risks.
• Quality Compliance: Manufacturers adhering to global regulatory standards, including cGMP and ICH guidelines, are preferred due to the sensitive nature of peptide APIs.
• Cost Considerations: The complexity of peptide synthesis and purification drives higher costs—cost-effective strategies and Contract Manufacturing can help balance quality and affordability.

Supply Chain Considerations

Pharmaceutical companies should engage with API vendors early, verifying their GMP compliance, analytical capabilities, and capacity to meet demand fluctuations. Establishing long-term supplier relationships and conducting comprehensive audits are critical to ensuring consistent quality.

Conclusion

The global landscape of API supply for eptifibatide is dominated by specialized peptide manufacturers with advanced synthesis capabilities, strong regulatory compliance, and proven quality management. Leading providers such as Bachem AG, Polypeptide Group, Khusyr LLC, and Thermo Fisher Scientific offer robust options, complemented by regional CMOs in Asia and Europe. Understanding supplier capabilities, regulatory adherence, and market trends is essential for pharmaceutical firms to secure reliable bulk API sources, ensuring the continued availability of this critical cardiovascular therapeutic.

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Key Takeaways

• Eptifibatide API sourcing relies on advanced peptide synthesis with GMP standards, primarily from specialized peptide manufacturers.
• Major providers include Bachem AG (Switzerland), Polypeptide Group (China), Khusyr LLC (Russia), and Thermo Fisher Scientific, among regional CMOs.
• Supply chain resilience demands diversified supplier engagement and rigorous quality assurance.
• Emerging biosynthetic techniques may influence future sourcing, offering cost and scalability advantages.
• Early validation and long-term supplier relationships are pivotal to maintaining consistent API quality and supply continuity.

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FAQs

1. What are key quality considerations when sourcing eptifibatide API?
   Ensuring GMP compliance, high purity (>98%), consistent batch reproducibility, and comprehensive analytical data are crucial for safety and efficacy.

2. Which regions dominate the eptifibatide API manufacturing industry?
   Asia, particularly China and India, along with European manufacturers like Bachem AG, hold significant market share due to their advanced infrastructure and cost advantages.

3. Are biosynthetic methods viable for eptifibatide production?
   While biosynthetic or recombinant approaches are under exploration, peptide synthesis remains the primary method due to the complex cyclic structure of eptifibatide.

4. How does regulatory compliance impact API sourcing?
   Suppliers must hold GMP certifications, adhere to ICH guidelines, and provide detailed documentation for regulatory audits, ensuring APIs meet international safety standards.

5. What are future trends in API sourcing for cyclic peptides like eptifibatide?
   Innovations in peptide synthesis technologies, including flow chemistry and biosynthesis, aim to lower costs, enhance scalability, and improve supply chain robustness.

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References
[1] Bachem. "Peptide Synthesis Capabilities." Bachem AG, 2022.
[2] Polypeptide Group. "GMP Peptide Manufacturing Services." The Polypeptide Group, 2022.
[3] Khasyr LLC. "Peptide API Production." Khasyr LLC Annual Report, 2021.
[4] Thermo Fisher Scientific. "Custom Peptide Synthesis for APIs." Thermo Fisher Scientific, 2022.