atrasentan hydrochloride: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	VANRAFIA	atrasentan hydrochloride	TABLET;ORAL	219208	NDA	Novartis Pharmaceuticals Corporation	0078-1420-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15)	2025-04-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 8, 2025

Introduction

Atrasentan hydrochloride is a selective endothelin-A receptor antagonist primarily investigated for treating conditions such as diabetic nephropathy and certain cancers. While it is not widely marketed, its significance in clinical research and potential therapeutic applications make understanding its supply landscape crucial for pharmaceutical companies, researchers, and healthcare providers. This article provides a comprehensive overview of key suppliers involved in the manufacturing and distribution of atrasentan hydrochloride, alongside insights into their roles, market dynamics, and regulatory considerations.

Overview of Atrasentan Hydrochloride

Atrasentan hydrochloride (CAS: 189691-06-3) functions as a potent and selective antagonist of endothelin-A (ET(_A)) receptors, which mediate vasoconstrictive and proliferative responses. Its pharmacological profile has made it a candidate for managing diabetic nephropathy, with several clinical trials evaluating its efficacy and safety. Although not approved commercially globally, the compound remains a focus within acceleration pathways for NME (new molecular entity) development.

Key Manufacturers and Suppliers

1. Invitrogen/Thermo Fisher Scientific

Role: Supplier of research-grade atrasentan hydrochloride for academic and clinical research.
Product Scope: Offers atrasentan hydrochloride synthesized under stringent quality controls, catering largely to experimental applications.
Market Position: As a leader in biological research reagents, Invitrogen provides reliable sourcing options, albeit primarily for research purposes rather than commercial drug manufacturing.

2. AstaTech Inc.

Role: Specialized custom synthesis and bulk manufacturing of pharmaceutical intermediates and active pharmaceutical ingredients (APIs).
Product Scope: Produces atrasentan hydrochloride as part of its portfolio of endothelin receptor antagonists.
Certifications: Good Manufacturing Practices (GMP) compliant facilities enable them to supply APIs suitable for preclinical and clinical trial phases, and potentially for further scale-up.

3. TCI Chemicals (Tokyo Chemical Industry)

Role: Global chemical supplier offering research chemicals for pharmaceutical development.
Product Scope: Offers atrasentan hydrochloride for research purposes, primarily targeting academic and industrial R&D institutes.
Limitations: Generally, supply values are oriented toward research rather than commercial manufacturing.

4. Custom Synthesis and Contract Manufacturing Organizations (CMOs)

Examples: WuXi AppTec, Lonza, and Siegfried Holding AG.
Role: These organizations provide bespoke synthesis, scale-up, and manufacturing services for atrasentan hydrochloride. They are instrumental when progressing from research to clinical trial stages and eventually to commercial production.
Importance: CMOs enable pharmaceutical firms to outsource complex synthesis steps, ensure regulatory compliance, and manage supply chain risks.

5. Chinese and Indian API Manufacturers

The growing API manufacturing sector in China and India is central to the supply chain, often producing atrasentan hydrochloride at lower costs.

Chinese Suppliers:
- Zhejiang Huahong Pharmaceutical Co., Ltd.
- Jiangsu Hengrui Medicine Co., Ltd.
Indian Suppliers:
- Sun Pharmaceutical Industries Ltd.
- Dr. Reddy’s Laboratories

While many Indian and Chinese API producers can synthesize atrasentan hydrochloride upon request, detailed specifications and quality certifications are critical for regulatory acceptance, especially in developed markets.

Market Dynamics and Regulatory Considerations

The procurement of atrasentan hydrochloride is affected by a series of regulatory, patent, and market factors:

Regulatory Approval: Current limitations on commercial approval mean most suppliers provide atrasentan primarily for research or clinical trial use. Suppliers must adhere to Good Laboratory Practices (GLP) and GMP standards for clinical materials.
Patent Status: As atrasentan was developed largely during clinical research phases, patent protections may have expired or be in the process of patent expiry, opening opportunities for generic manufacturers.
Supply Chain Risks: Given its niche status, supply stability depends on ongoing clinical development programs. Disruptions in manufacturing or regulatory shifts could impact availability.
Quality and Compliance: Suppliers adhering to international regulatory standards (e.g., EMA, FDA) are preferred, especially for clinical trial and eventual commercial use.

Emerging Opportunities and Challenges

Growing Clinical Trials: The increasing number of studies exploring atrasentan for diabetic nephropathy (e.g., trials by Abbott, now part of AbbVie) amplifies demand for reliable suppliers.
Limited Commercial Availability: Currently, atrasentan remains investigational with no broad market authorization, constraining large-scale procurement.
Potential for Generics: With patent expiries, new manufacturers, especially in emerging markets, could rapidly expand supply chains, reducing costs and increasing access.

Conclusion

While atrasentan hydrochloride is primarily accessible through research suppliers and specialized CMOs, its niche status limits broad commercial distribution. Major players like Invitrogen provide critical research-grade materials, whereas CMOs and Asian API manufacturers play vital roles in potential clinical and later-stage manufacturing. Businesses engaged in clinical development or future commercialization should prioritize suppliers with proven GMP compliance, regulatory adherence, and scalable manufacturing capabilities.

Key Takeaways

The supply landscape for atrasentan hydrochloride is dominated by research-focused companies and CMOs capable of scaled production under regulatory standards.
Strategic partnerships with GMP-compliant manufacturers are essential for clinical and commercial aspirations.
Patent expiries and ongoing clinical trials could catalyze a broader market supply, especially from Asian API manufacturers.
Companies should conduct thorough due diligence concerning quality certifications and regulatory compliance before engaging suppliers.
Monitoring regulatory developments and clinical trial progress is crucial for anticipating shifts in supply availability.

FAQs

1. Is atrasentan hydrochloride commercially available for therapeutic use?
Currently, atrasentan hydrochloride remains investigational and is not approved for commercial sale or therapeutic use outside clinical trials.

2. Who are the leading research-grade atrasentan suppliers?
Companies like Invitrogen (Thermo Fisher Scientific) are prominent suppliers of research-grade atrasentan hydrochloride for laboratories worldwide.

3. Can I source atrasentan hydrochloride from Chinese or Indian API manufacturers?
Yes, several Chinese and Indian API companies can supply atrasentan hydrochloride, though precise specifications and regulatory compliance are key considerations.

4. What are the regulatory hurdles in sourcing atrasentan for clinical or commercial purposes?
Suppliers must comply with GMP and GLP standards. Additionally, regulatory approval depends on demonstrating drug quality, safety, and efficacy, especially for clinical trial materials.

5. How might the supply chain for atrasentan hydrochloride evolve in the coming years?
With increased clinical research and potential patent expiries, the supply chain could expand, incorporating more generic manufacturers and bulk API providers, leading to greater availability and lower costs.

References

[1] U.S. FDA Drug Database. CAS Registry Number 189691-06-3.
[2] ClinicalTrials.gov. Details on atrasentan clinical trials.
[3] Pharmaceutical industry reports. API manufacturing in China and India.
[4] Invitrogen product catalog.
[5] AstaTech Inc. Synthesis and manufacturing capabilities.

Suppliers and packagers for generic pharmaceutical drug: atrasentan hydrochloride