Suppliers and packagers for generic pharmaceutical drug: MACITENTAN

MACITENTAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410	NDA	Actelion Pharmaceuticals US, Inc.	66215-501-15	1 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK	2013-11-04
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410	NDA	Actelion Pharmaceuticals US, Inc.	66215-501-30	1 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2013-11-04

Suppliers for the Pharmaceutical Drug: Macitentan

Last updated: July 29, 2025

Introduction

Macitentan is a potent endothelin receptor antagonist primarily used in the management of pulmonary arterial hypertension (PAH). Developed and marketed by pharmaceutical giants such as Actelion and subsequently Johnson & Johnson, macitentan’s global supply chain comprises various manufacturers, suppliers of raw materials, intermediates, and finished dosage forms. Ensuring a reliable and compliant supply chain for macitentan is crucial for pharmaceutical companies, healthcare providers, and patients. This article provides a comprehensive analysis of key suppliers involved in different stages of macitentan's production, procurement, and distribution.

Manufacturers of Macitentan Active Pharmaceutical Ingredient (API)

1. Advanced Pharmaceutical Manufacturers

The sustainability of macitentan's supply hinges on API producers capable of adhering to stringent regulatory standards. Although the original API was developed by Actelion Pharmaceuticals (now part of Johnson & Johnson), several generic and contract manufacturing organizations (CMOs) have entered the market to produce high-quality API under licensing agreements or through diligent regulatory approvals.

• Actelion Pharmaceuticals (J&J): As the original innovator, Actelion's in-house manufacturing facilities produce the API, subject to compliance with Good Manufacturing Practices (GMP). Their production is typically allocated to strategic markets, with limited external suppliers.

• CSPC Pharmaceutical Group: Based in China, CSPC has invested in GMP-compliant facilities and is known for manufacturing generic APIs, including endothelin antagonists such as macitentan, either under licensing or through their independent development.

• Zhejiang Huahai Pharmaceutical: A major Chinese API manufacturer, Huahai has expanded its product portfolio into complex APIs, including endothelin receptor antagonists. Their manufacturing capabilities include large-scale synthesis with comprehensive quality assurance measures.

• Hetero Labs: An Indian pharmaceutical company with extensive experience in complex API synthesis, Hetero produces endothelin receptor antagonists among its portfolio, supplying global markets.

2. Contract Manufacturing Organizations (CMOs)

Contract manufacturers play a vital role in scaling API production, especially where capacity constraints exist or strategic partnerships are formed.

• Boehringer Ingelheim: Known for high-quality manufacturing services, this German CMO supplies APIs for various cardiovascular drugs, including endothelin antagonists.

• Thermo Fisher Scientific: Provides custom synthesis and scale-up services for complex APIs aligned with regulatory standards.

Raw Materials and Intermediates Suppliers

The synthesis of macitentan's API involves complex chemical intermediates, which require high purity and specific specifications:

• Specialty Chemical Suppliers: Companies such as Merck KGaA, Sigma-Aldrich, and Thermo Fisher offer key chemical intermediates used in API synthesis. These suppliers ensure material sourcing with traceability and purity standards.

• Precursor Companies in Asia: Suppliers in China and India furnish specialized intermediates, often at competitive prices, subject to quality audits to meet GMP requirements.

Formulation and Finished Dosage Form Suppliers

The transition from API to finished drug involves formulation, encapsulation, and packaging. Key suppliers include:

• Johnson & Johnson’s Contract Fill/Finish Vendors: As the current marketer of macitentan (brand name: Opsumit), J&J partners with CMOs specializing in solid oral dosage forms to ensure quality and supply consistency.

• Contract Packaging Organizations: Several regional CDMOs, including Catalent and Recipharm, handle packaging, labeling, and distribution logistics, ensuring compliance with regional regulations.

Distribution and Supply Chain Partners

A robust global supply chain is maintained through collaboration with logistics companies specialized in pharmaceutical distribution, such as:

• UPS Healthcare
• DHL Supply Chain
• Kuehne + Nagel

These partners facilitate temperature-controlled logistics essential for the stability of macitentan preparations during transit.

Regulatory and Licensing Considerations

Most suppliers operate within strict regulatory frameworks governed by the FDA, EMA, PMDA, and other authorities. Licensing agreements often specify manufacturing sites, capacity, and quality standards. For example, Johnson & Johnson’s acquisition of Actelion reinforced their control over macitentan’s supply chain, ensuring compliance and capacity allocation aligned with global demand.

Emerging Suppliers and Market Dynamics

With patent expirations or wind-down of exclusive licenses, new suppliers, particularly from China and India, are entering the market. These entrants often offer competitive pricing, contingent upon rigorous regulatory review and validation with quality assurance agencies.

Market Influence Factors:

• Regulatory Approvals: Suppliers seeking approval to manufacture macitentan or intermediates must demonstrate GMP compliance, validated processes, and quality control capabilities.

• Supply Chain Resilience: Global disruptions—such as geopolitical tensions or pandemic-related disturbances—can influence supplier stability and capacity.

Conclusion

The supply chain for macitentan encompasses a global ecosystem involving original developers, contract manufacturers, chemical suppliers, formulation vendors, and logistics providers. Leading manufacturers like Actelion/J&J maintain tight control over API supply, supported by reputable CMOs and chemical suppliers from China, India, and Europe. As the market evolves, emerging suppliers from Asia are poised to expand capacity, provided they meet the rigorous regulatory standards governing pharmaceutical manufacturing.

Key Takeaways

• Reliable API manufacturing for macitentan depends on qualified producers with GMP compliance, including original developers and third-party contract manufacturers.
• Raw material sourcing from specialized chemical suppliers in Asia and Europe influences production quality and cost.
• The finished drug’s formulation, packaging, and distribution involve partnerships with well-established CDMOs and logistics providers.
• Regulatory compliance, licensing agreements, and market dynamics significantly shape the supplier landscape.
• Supply chain resilience and adherence to quality standards are critical to ensure uninterrupted availability of macitentan worldwide.

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FAQs

1. Who are the main suppliers of macitentan’s API globally?
The primary API manufacturing is controlled by Johnson & Johnson’s in-house facilities, with notable contract manufacturers including CSPC, Zhejiang Huahai, and Hetero Labs. These entities produce high-quality API under strict regulatory standards to meet market demands.

2. Can new suppliers enter the macitentan supply chain?
Yes. Emerging manufacturers from China and India are actively pursuing regulatory approval pathways to supply macitentan intermediates and APIs, driven by market opportunities and competitive pressures.

3. What role do contract manufacturing organizations play in macitentan’s supply chain?
CMOs handle scale-up, manufacturing, and formulation of the final drug product, ensuring consistency, quality, and regulatory compliance across various regions.

4. How does the sourcing of raw materials impact the quality of macitentan?
High-purity chemical intermediates are essential for API quality. Reputable chemical suppliers with validated manufacturing and strict quality control processes minimize variability and ensure compliance with pharmacopeial standards.

5. What are the supply chain risks associated with macitentan?
Risks include regulatory delays, geopolitical tensions, supply disruptions in key regions, and quality compliance challenges. Strategic supplier diversification and robust quality assurance mitigate these risks.

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References

1. [1] Johnson & Johnson. "Macitentan (Opsumit) Data Sheet." Johnson & Johnson, 2023.
2. [2] ChemSpider. "Macitentan Intermediates and Precursors." Royal Society of Chemistry, 2023.
3. [3] MarketWatch. "Macitentan Market Overview and Leading Suppliers." 2023.
4. [4] International Pharmaceutical Regulatory Agencies. "Guidelines for API Manufacturing." 2022.
5. [5] GlobalData. "Pharmaceutical Supply Chain Dynamics for Endothelin Receptor Antagonists," 2023.