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 and packagers for OPSUMIT

Last updated: May 28, 2026

OPSUMIT (macitentan) suppliers: who manufactures, packages, and supplies the drug in the US and EU

Executive summary: OPSUMIT is supplied in the US and EU as a branded, finished-dose product of the endothelin receptor antagonist macitentan. Actelion/Janssen is the market authorization holder globally, while manufacturing and packaging responsibilities are split across Janssen manufacturing sites and contract manufacturing partners that support finished product release, labeling, and distribution. Because supplier rosters change by market, dosage strength, and packaging configuration, an accurate “who supplies OPSUMIT” list must be taken from the latest country-specific product labeling and regulatory registrations (e.g., EMA EPAR/Annex product details and US FDA labeling/Drug Listing).

Data not provided: No specific market (US, EU, UK, specific country) and no dosage form/strength (most commonly 10 mg film-coated tablets; OPSUMIT is also marketed in sentinel pack formats) were specified, and supplier names must be sourced from the current approved product documents for that exact market configuration. Under the operating constraints, a complete and accurate supplier roster cannot be produced without the needed regulatory-labeled supplier dataset.

What companies supply OPSUMIT (macitentan) finished product?

Featured snippet answer: OPSUMIT is supplied as a finished pharmaceutical product under the Janssen/Actelion commercial umbrella, with manufacturers and packagers listed on the market-specific product labeling and regulatory product details.

US supplier listing: where to find finished drug manufacturer and packager

• Look for:
  • “Manufactured for” / “Distributed by” in the latest US FDA prescribing information and carton/label text.
  • Drug Labeling / NDC-level “Manufactured for” and “Packaged by” lines.
• Typical supplier categories:
  • Finished dose manufacturing site
  • Packaging site (bottling/blistering and labeling)
  • Secondary distributor (often Janssen entities)

EU supplier listing: where to find manufacturing and batch release

• Look for:
  • EPAR “Product details” and Annex sections listing:
    • Manufacturers
    • Batch release
    • Packers

Which manufacturers make macitentan tablets for OPSUMIT?

Featured snippet answer: The macitentan active ingredient is produced via specialized API synthesis and then formulated into film-coated tablets, with API suppliers and finished product manufacturers listed in regulatory dossiers and product labeling.

API vs finished product supplier split

• API manufacturing: typically disclosed in technical documentation and sometimes not fully disclosed on consumer labeling.
• Finished dose manufacturing: explicitly listed on the product label/SmPC for each market.
• Contract manufacturing is common in oral solid dose supply chains, so the “supplier” may differ from the “marketing authorization holder.”

What packaging suppliers distribute OPSUMIT tablets (blister vs bottle)?

Featured snippet answer: Packaging suppliers are market- and NDC/configuration-specific and appear on labeling as “packaged by” and in some cases “distributed by” lines.

Packaging and labeling steps that identify suppliers

• Primary packaging: blister (common for 10 mg tablets), or bottle depending on market and NDC
• Secondary packaging: carton, leaflet inserts, labeling compliant with local rules
• Batch labeling and release: often at a specific named site

Do OPSUMIT suppliers differ by strength (10 mg) or market?

Featured snippet answer: Yes. Manufacturing and packaging sites can vary by strength, NDC, and country because release testing, packaging capacity, and regulatory approvals are tied to local product presentations.

What changes across markets

• Packaging format (blister vs bottle)
• Label text language and artwork
• Release site for batch testing
• Distributor entity name

How does FDA Orange Book listing affect supplier identification for OPSUMIT?

Featured snippet answer: Orange Book listings primarily establish approval status, application type, and patents, not complete supply chain details. Supplier names are more reliably obtained from FDA label text, NDC directories, and drug listing “labeler” and manufacturer entries.

What Orange Book does provide

• Whether OPSUMIT has active patents and patent numbers (for exclusivity/patent fencing)
• Application/approval references tied to product manufacturing details in regulatory records

What is the supplier network structure for OPSUMIT commercialization?

Featured snippet answer: OPSUMIT’s supplier network typically follows:

1. Marketing authorization holder (regulatory responsibility)
2. Finished-dose manufacturers (tablet production)
3. Packagers (blistering, bottling, secondary labeling)
4. Wholesalers/distributors (market distribution)

Common operational reasons suppliers change

• GMP capacity shifts among sites
• Contract manufacturing onboarding or offboarding
• Packaging line qualification and batch release transfer

Which company is the labeler/distributor for OPSUMIT in the US and EU?

Featured snippet answer: OPSUMIT is marketed under Janssen/Actelion branding, with the US labeler and distributor shown on the latest FDA carton/label and NDC listing, and EU manufacturer/packager shown in EPAR product details for each member state.

What generic entry risks affect OPSUMIT supply and reliance on specific manufacturers?

Featured snippet answer: Patent and exclusivity timelines do not determine supplier identity directly, but generic launch schedules can trigger contract manufacturing shifts and inventory planning that change which sites supply finished dose.

Commercial and supply-chain implications

• If branded volumes decline post-generic entry, supply contracts may be rebalanced
• If demand spikes due to switching or shortages, packaging sites can be expanded

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Key Takeaways

• OPSUMIT suppliers are identified in market-specific regulatory product details and current label text.
• Supplier names can differ by country, strength, and packaging configuration, especially between blister vs bottle presentations.
• Orange Book establishes patent/exclusivity context, while manufacturer and packager names come from FDA labeling/NDC labeler lines and EMA EPAR product details.

FAQs

1. Who is listed as the manufacturer for OPSUMIT on the latest US label?
2. What does the EMA EPAR list as batch release and packaging sites for OPSUMIT?
3. Are OPSUMIT 10 mg blister and bottle presentations supplied by the same packager?
4. How do supplier lists change when OPSUMIT NDCs are updated or relabeled?
5. Does contract manufacturing change the regulatory “manufacturer” entry for OPSUMIT in the EU?

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References

1. FDA. Drugs@FDA: OPSUMIT (macitentan). https://www.accessdata.fda.gov/scripts/cder/daf/
2. EMA. EPAR: OPSUMIT (macitentan). https://www.ema.europa.eu/ema/
3. FDA Orange Book. OPSUMIT (macitentan). https://www.accessdata.fda.gov/scripts/cder/daf/