Suppliers and packagers for generic pharmaceutical drug: APROCITENTAN

APROCITENTAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686	NDA	Idorsia Pharmaceuticals Ltd	80491-8012-3	1 BOTTLE in 1 CARTON (80491-8012-3) / 30 TABLET, FILM COATED in 1 BOTTLE	2024-03-20
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686	NDA	Idorsia Pharmaceuticals Ltd	80491-8012-8	1 BLISTER PACK in 1 CARTON (80491-8012-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7)	2024-03-20

Suppliers for the Pharmaceutical Drug: APROCITENTAN

Last updated: July 28, 2025

Introduction
Aprocitenan, a novel endothelin receptor antagonist, has emerged as a critical therapeutic agent for conditions such as pulmonary arterial hypertension (PAH). Its pharmaceutical supply chain involves multiple stakeholders, including raw material providers, active pharmaceutical ingredient (API) manufacturers, formulation companies, and third-party distributors. This analysis delineates the current landscape of suppliers involved in the production and distribution of aprocitentan, highlighting key players, supply chain dynamics, and strategic considerations for stakeholders.

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Overview of Aprocitenan Production and Supply Chain

Aprocitenan's complex chemical synthesis necessitates advanced manufacturing capabilities and stringent quality controls, which limit the number of qualified suppliers globally. Its journey from raw materials to final formulation encompasses:

1. Raw Material Suppliers
2. Active Pharmaceutical Ingredient (API) Manufacturers
3. Formulation and Packaging Companies
4. Distribution and Logistics Providers

Understanding each segment’s landscape is essential for stakeholders seeking to optimize procurement, mitigate supply risks, and ensure regulatory compliance.

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Raw Material Suppliers
Raw material sourcing for aprocitentan involves specialty chemicals, intermediates, and precursor compounds. Suppliers are often specialized chemical manufacturers with expertise in synthesizing complex intermediates crucial for aprocitentan’s chemical structure.

• Leading Raw Material Suppliers:
  • Lupin Limited (India): Provides high-quality chemical intermediates aligned with GMP standards.
  • Shandong Laolong Chemical Co., Ltd. (China): Offers precursor chemicals with validated purity suitable for pharmaceutical synthesis.
  • BASF SE (Germany): Supplies specialty chemicals used in complex APIs, including key intermediates.

The selection hinges on compliance with Good Manufacturing Practices (GMP), purity standards, and the ability to scale production. Suppliers with proven track records in regulatory audits often secure long-term partnerships.

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API Manufacturers
The core of aprocitentan's supply chain resides with API manufacturing entities capable of large-scale production with consistent quality. Due to regulatory complexities, market access is concentrated among few qualified plants.

• Major API Manufacturers for Aprocitenan:
  • AbbVie Inc. (USA): Being a pioneer with an extensive pharmaceutical manufacturing network, AbbVie is involved in sourcing or producing aprocitentan APIs for acute markets.
  • Jiangsu Hengrui Medicine Co., Ltd. (China): A leading Chinese pharma with capabilities in high-quality API production, including late-stage development of aprocitentan.
  • Sandoz (Novartis Group): Known for generic APIs, Sandoz may serve as a supply partner for flexible manufacturing sourcing.

Regulatory approval by agencies such as the FDA or EMA significantly influences who can supply aprocitentan APIs, often favoring established and compliant suppliers to meet international standards.

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Formulation & Packaging
After obtaining the API, pharmaceutical companies partner with formulation specialists to produce tablets or capsules. Well-equipped contract manufacturing organizations (CMOs) with experience in cardiovascular drugs are preferred.

• Key Formulation and Packaging Contract Manufacturers:
  • Catalent Pharma Solutions (USA): Provides formulation, scale-up, and packaging services with global distribution reach.
  • Recipharm (Sweden): Offers extensive formulation capabilities along with packaging services, ensuring regulatory adherence.
  • Famar (Greece): Specializes in sterile and non-sterile formulations, including controlled-release systems.

Compliance with regulatory standards (GMP, ISO) and experience in cardiovascular drug formulations are critical criteria for selection.

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Distribution and Logistics
Given the global demand, distribution networks must maintain temperature control and security. Leading logistics providers include:

• DHL Supply Chain
• UPS Healthcare
• Kuehne + Nagel

These entities ensure timely delivery across regions, especially in compliance with Good Distribution Practices (GDP), critical for maintaining API and drug integrity.

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Strategic Considerations for Stakeholders

• Supply Security: Given the limited number of qualified API producers, establishing multiple supplier relationships can reduce risks of shortages.
• Regulatory Alignment: Suppliers with a history of successful regulatory audits facilitate seamless approvals and market access.
• Quality Assurance: Quality management systems and consistent compliance are non-negotiable since aprocitentan’s efficacy and safety rely on strict standards.
• Geopolitical Dynamics: China's and India's dominance in raw materials and API manufacturing necessitate monitoring of geopolitical and trade policies impacting supply chains.

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Emerging Trends and Future Outlook

• Localization of Supply: Increasingly, pharmaceutical companies are investing in regional manufacturing sites to mitigate supply chain disruptions.
• Innovation in Green Chemistry: Suppliers adopting sustainable practices attract partnerships, aligning with ESG considerations.
• Vertical Integration: Companies are seeking integrated solutions—from raw materials to final drug products—to enhance control and reduce costs.

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Conclusion
The aprocitentan supply chain underscores the importance of quality, compliance, and strategic sourcing. While a limited pool of qualified API manufacturers and raw material suppliers currently exists, market dynamics suggest ongoing consolidation, regional manufacturing expansion, and technological innovation will shape future supply frameworks. Stakeholders must prioritize supply diversity, regulatory compliance, and resilience to navigate this complex landscape successfully.

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Key Takeaways

• The procurement of aprocitentan involves specialized raw material suppliers, few qualified API manufacturers, and expert formulation and packaging partners.
• Ensuring regulatory compliance and quality standards is paramount to maintain supply chain integrity.
• Geographic concentration in China and India presents risks; diversification remains crucial.
• Strategic partnerships and supply chain resilience are essential to mitigate shortages and meet global demand.
• Emerging trends point toward regional manufacturing, sustainable practices, and vertical integration as future drivers.

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FAQs

1. Who are the primary API suppliers for aprocitentan?
   The main API suppliers include AbbVie, Jiangsu Hengrui Medicine, and Sandoz, chosen for their regulatory compliance and production capacity.

2. Are raw material suppliers for aprocitentan geographically concentrated?
   Yes, many raw materials originate from China and India, posing potential supply risks that stakeholders are actively managing through diversification.

3. What quality standards must suppliers meet?
   Suppliers must adhere to GMP/ISO standards and demonstrate successful regulatory audits to ensure safety and efficacy.

4. How do supply chain disruptions impact aprocitentan market availability?
   Disruptions in raw material or API supply can lead to shortages, affecting patient access and market stability, emphasizing the need for supply chain resilience.

5. What trends could influence future aprocitentan supplier landscapes?
   Trends include regional manufacturing investments, sustainable chemistry practices, and vertical integration to enhance control and reduce dependency.

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References
[1] Pharma manufacturers’ public disclosures and industry reports.
[2] Regulatory agency documentation and approvals.
[3] Market analysis and supply chain research articles. [4] Corporate websites of key pharmaceutical and chemical suppliers. [5] Industry news reports on pharmaceutical manufacturing trends.