Bulk Pharmaceutical API Sources for UPTRAVI

Bulk Pharmaceutical API Sources for UPTRAVI

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-009-019-323
AKos Consulting & Solutions		AKOS024457572
MedChemexpress MCE		HY-14870
AbaChemScene		CS-3774
TargetMol		T3216

Bulk Active Pharmaceutical Ingredient (API) Sources for UPTRAVI (Selexipag)

Last updated: July 28, 2025

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Introduction

UPTRAVI (selexipag) is a groundbreaking oral selective prostacyclin receptor agonist primarily indicated for the treatment of pulmonary arterial hypertension (PAH). Approved by the U.S. Food and Drug Administration (FDA) in December 2015, UPTRAVI has established itself as a vital therapeutic option, owing to its targeted mechanism of action. Central to its manufacturing is the procurement of high-quality bulk Active Pharmaceutical Ingredient (API). As the demand for UPTRAVI expands across global markets, understanding the API sourcing landscape, including key suppliers and responsible manufacturing practices, becomes essential for pharmaceutical companies, healthcare providers, and supply chain stakeholders.

This article delineates the primary sources of the UPTRAVI API (selexipag), explores the strategic considerations in API procurement, and highlights the role of contract manufacturing organizations (CMOs) in ensuring supply chain resilience.

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Overview of Selexipag API

Selexipag is a novel, orally active non-prostanoid prostacyclin receptor agonist. Its synthesis involves complex multi-step chemical processes, including heterocyclic chemistry, sulfur chemistry, and chiral synthesis to produce the highly specific isomeric form required for therapeutic efficacy. The manufacturing of selexipag API demands stringent quality controls, adherence to Good Manufacturing Practices (GMP), and reliable sourcing of raw materials.

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Key API Manufacturers and Suppliers for UPTRAVI

1. Primary API Manufacturing Companies

The landscape of API sourcing for UPTRAVI is characterized by a select group of specialized chemical manufacturing organizations, predominantly located in regions with a robust pharmaceutical production infrastructure such as Asia (particularly China and India), Europe, and North America.

a. Global Chemical Giants and Specialized API Manufacturers

• Sino Biopharmaceutical Limited (China): Known for high-volume chemical manufacturing and active participation in the synthesis of complex APIs, Sino Biopharmaceutical leverages extensive R&D capabilities. They supply APIs for multiple therapeutic categories, including agents for cardiovascular diseases.

• Hubei Yuancheng Pharmaceutical Co., Ltd. (China): Specializing in complex chemical APIs, Yuancheng offers custom synthesis services. Their portfolio includes prostacyclin analogs and receptor agonists, making them a pertinent source for selexipag API.

• NEO-Chem Co., Ltd. (South Korea): With capabilities in fine chemicals, NEO-Chem supplies pharmaceutical intermediates and APIs utilized in cardiovascular therapeutics, including compounds similar structurally to selexipag.

• Covestro AG (Germany): As a key provider of specialized chemicals, Covestro offers raw materials and intermediates critical in selexipag synthesis, although they are not direct API manufacturers.

b. Contract Manufacturing Organizations (CMOs)

• Catalent Pharma Solutions: Globally recognized for its comprehensive development and manufacturing services, Catalent offers API production in compliance with cGMP standards, including complex molecules such as selexipag.

• Aenova Group: A European CMO with extensive experience in active pharmaceutical ingredient synthesis, Aenova supplies APIs for cardiovascular drugs and operates flexible manufacturing facilities that can produce selexipag API.

• Cambrex Corporation: With a focus on small molecule APIs, Cambrex provides scalable synthesis and API manufacturing services, including complex and chiral compounds akin to selexipag.

2. Raw Material and Intermediate Suppliers

The synthesis of selexipag involves several key precursors and intermediates, often sourced from specialty chemical suppliers:

• Sigma-Aldrich (Merck): Supplies various chemical intermediates required in selexipag synthesis, including heterocyclic building blocks.

• TCI Chemicals: Offers high-purity chemical intermediates suitable for pharmaceutical synthesis.

• Alfa Aesar (Thermo Fisher Scientific): Provides reagents and intermediates necessary for complex chemical processes involved in API manufacture.

3. Regulatory and Quality Considerations

Manufacturers supplying APIs for UPTRAVI must comply with rigorous GMP standards enforced by regulatory bodies such as the FDA, EMA, and PMDA. Suppliers must provide comprehensive data packages, including Certificates of Analysis (CoA), stability data, and purity specifications.

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Strategic Considerations in API Sourcing for UPTRAVI

Supply Chain Resilience

Given the complexity of selexipag synthesis, securing a diversified supplier base reduces risks associated with geopolitical disruptions, raw material shortages, or manufacturing outages. Companies frequently adopt dual sourcing strategies from established suppliers in different regions.

Quality and Compliance

High purity standards (>99%) and strict control of chiral purity are non-negotiable. Suppliers must demonstrate compliance with current GMP standards, validated manufacturing processes, and thorough documentation.

Cost and Lead Time

Balancing cost efficiency with assured quality often involves negotiating long-term procurement contracts and optimizing inventory management. Advanced planning mitigates delays inherent in complex chemical synthesis.

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Emerging Trends and Future Outlook

The API sourcing landscape for selexipag is arguably on the cusp of transformation, driven by innovations in synthesis processes and supply chain digitization. Notably:

• Process Innovation: Emerging green chemistry approaches aim to shorten synthesis routes and reduce environmental impact, possibly diversifying supplier options.

• Manufacturing Capacity Expansion: Investment by Asian API manufacturers in capacity expansion is likely, enhancing global supply security.

• Regulatory Harmonization: Increasingly stringent international standards will motivate suppliers to adopt harmonized quality management systems.

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Conclusion

The sourcing of the selexipag API for UPTRAVI hinges on a global network of specialized manufacturers and intermediates suppliers. Leading companies in China, South Korea, and Europe currently dominate the supply chain, supported by robust CDMO relationships that guarantee high-quality, GMP-compliant APIs. As the pharmaceutical landscape evolves, diversification, technological innovation, and rigorous quality control remain pivotal for a resilient supply chain. Stakeholders must prioritize strategic partnerships with verified suppliers to ensure uninterrupted access to this critical therapeutic agent.

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Key Takeaways

• The primary API sources for UPTRAVI are specialized chemical manufacturers and CDMOs located mainly in Asia and Europe, with established reputations for quality and compliance.

• Ensuring supply chain resilience involves diversifying suppliers, maintaining long-term relationships, and adhering to strict GMP standards.

• The complex synthesis of selexipag necessitates sourcing high-purity intermediates, often from well-regarded specialty chemical companies.

• Regulatory compliance and documentation are critical in maintaining manufacturing quality and continuity.

• Innovations in process chemistry and capacity expansion are likely to influence future API sourcing strategies for UPTRAVI.

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FAQs

Q1: What are the main challenges in sourcing the selexipag API?
A: Challenges include complex multi-step synthesis requiring high precision, ensuring GMP compliance across suppliers, managing global logistics disruptions, and maintaining high purity standards.

Q2: Which regions dominate the API supply chain for UPTRAVI?
A: Predominantly Asia (China and South Korea) and Europe, with several Contract Manufacturing Organizations playing key roles.

Q3: How do regulatory standards influence API sourcing?
A: Suppliers must meet international GMP standards, provide comprehensive documentation, and undergo inspections to ensure quality and facilitate regulatory approval processes.

Q4: Are there alternative sources or methods for synthesizing selexipag?
A: Ongoing research into process innovations aims to develop more efficient, sustainable synthesis routes, potentially expanding supplier options.

Q5: What steps can companies take to ensure a reliable supply of selexipag API?
A: They should establish diversified supplier networks, conduct thorough quality assessments, engage in long-term contracts, and monitor geopolitical and logistical risks.

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References

[1] U.S. Food and Drug Administration. UPTRAVI (selexipag) prescribing information. 2015.
[2] European Medicines Agency. Summary of Product Characteristics for UPTRAVI. 2016.
[3] Healthcare industry reports and market analyses on API supply chains.