Suppliers and packagers for opsumit

opsumit

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: OPSUMIT

Last updated: July 29, 2025

Introduction

Opsumit, known generically as macitentan, is an oral endothelin receptor antagonist developed by Actelion Pharmaceuticals (now part of Johnson & Johnson [J&J]). Approved primarily for treating pulmonary arterial hypertension (PAH), Opsumit has garnered attention from healthcare providers and pharmaceutical supply chains worldwide. Ensuring a reliable supply chain involves identifying legitimate suppliers at various stages, from manufacturing to distribution. This article provides an exhaustive overview of key suppliers involved in the supply of Opsumit, analyzing their roles, geographic distribution, and implications for stakeholders.

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Manufacturers of Opsumit

1. Actelion Pharmaceuticals / Johnson & Johnson

Actelion, before its acquisition by Johnson & Johnson in 2017, was the primary developer and manufacturer of Opsumit. Under J&J’s stewardship, the manufacturing process has standardised across multiple facilities to meet global regulatory standards, including Good Manufacturing Practice (GMP).

• Manufacturing Sites:

  • Allschwil, Switzerland: The primary R&D and manufacturing hub.
  • Other Locations: Follow-up production and formulation facilities are located in various countries, such as the United States and parts of Europe, to ensure supply continuity.

• Role:
  Actelion/J&J functions as the originator and main supplier, responsible for drug synthesis, formulation, quality control, and regulatory compliance.

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Raw Material and Active Pharmaceutical Ingredient (API) Suppliers

2. API Suppliers

Manufacture of macitentan requires high-purity chemical synthesis, involving several critical raw materials:

• Key Raw Materials:

  • Ethylene glycol derivatives, amines, and complex heterocyclic compounds.

• Active Ingredient Synthesis:
  API production is typically centralized within J&J’s manufacturing facilities to maintain strict quality controls. For authorised generics or biosimilar competitions, third-party API suppliers may be involved.

3. Contract Manufacturing Organizations (CMOs)

While J&J largely retains control over API and final formulation manufacturing, some CMOs have been involved to supplement capacity or assist with formulation for regional markets to mitigate supply disruptions. These CMOs are verified and GMP-compliant entities globally.

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Distribution and Logistics

4. Wholesalers and Distributors

Distribution channels are extensive, encompassing global, regional, and local wholesalers to ensure availability in healthcare facilities:

• Major Global Distributors:

  • McKesson Corporation: A primary distributor for various regions, including North America.
  • AmerisourceBergen: Supplies to North America and international markets.
  • Alliance Healthcare: Key distributor in Europe and Asia.

• Regional Distributors:
  Local pharmaceutical distributors are certified by health authorities to facilitate local procurement, inventory management, and supply chain resilience.

5. Specialty Pharmacies and Hospitals

Opsumit, classified as a specialized therapy, is often supplied via specialty pharmacies, particularly in the United States where payers restrict access through prior authorization protocols.

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Regulatory and Certification Bodies

Compliance with numerous regulatory standards is essential for suppliers:

• Regulatory Bodies:

  • Food and Drug Administration (FDA) in the US.
  • European Medicines Agency (EMA).
  • Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

• Certifications:
  Suppliers and manufacturers must maintain GMP certification, Good Distribution Practice (GDP), and comply with international standards like ISO 13485 for medical devices involved in distribution.

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Potential Suppliers for Generic Versions

Following patent expiry or licensing agreements, multiple generic manufacturers may produce macitentan under different international jurisdictions. These suppliers typically source APIs from verified chemical manufacturers, adhering to similar standards as originators to ensure bioequivalence and regulatory approval.

Supply Chain Challenges and Considerations

• Patent Protections:
  Patents protect J&J’s production exclusivity until expiry (expected around 2027-2030 in key markets). Post-patent, generics could emerge from multiple manufacturers.

• Supply Disruptions:
  Geopolitical factors, manufacturing issues, or regulatory delays can impact supply continuity. J&J’s diversified manufacturing network and multiple distribution channels mitigate such risks.

• Supply Chain Transparency:
  Increasingly demanded by healthcare providers and regulators, transparency regarding supplier credentials and certifications is crucial for supply chain integrity.

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Implications for Stakeholders

• Healthcare Providers: Need reliable access to certified suppliers to ensure uninterrupted treatment.
• Pharmaceutical Distributors: Must verify supplier legitimacy and compliance with standards.
• Patients: Depend on a stable supply chain for consistent medication availability.
• Regulators: Require transparency and compliance across all supply chain tiers to uphold safety and efficacy standards.

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Key Takeaways

• The primary supplier of Opsumit is Actelion Pharmaceuticals, now operating under J&J, with manufacturing centralized in Switzerland.
• API production involves high-purity chemicals sourced from specialized suppliers, with some roles handled by CMOs.
• Distribution relies on major global wholesalers and regional distributors, supplemented by specialty pharmacies.
• Regulatory compliance, certification, and transparency remain critical for maintaining an effective supply chain.
• Post-patent, increasing global competition from generic manufacturers could diversify suppliers, influencing pricing and supply security.

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FAQs

1. Who is the primary manufacturer of Opsumit?
Actelion Pharmaceuticals, now part of Johnson & Johnson, remains the primary manufacturer responsible for formulation and global distribution.

2. Are there alternative suppliers for Opsumit?
Currently, J&J’s control dominates, but post-patent expiration may introduce generic manufacturers that sourced APIs from verified chemical suppliers.

3. How are the supply chains for Opsumit regulated?
All suppliers and manufacturers must adhere to international standards such as GMP and GDP, verified by regulatory agencies like the FDA and EMA.

4. What risks exist in the supply chain of Opsumit?
Potential risks include manufacturing disruptions, geopolitical issues, patent expirations, and regulatory delays, which can affect availability.

5. How can healthcare providers ensure access to genuine Opsumit?
By sourcing through verified distributors, checking for GMP and regulatory certifications, and maintaining relationships with authorized suppliers.

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References

[1] Johnson & Johnson. “Johnson & Johnson completes acquisition of Actelion.” 2017.
[2] U.S. Food & Drug Administration (FDA). “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).”
[3] European Medicines Agency (EMA). “Summary of Product Characteristics for Opsumit.”
[4] Industry reports on pharmaceutical supply chains and distribution networks.