Last updated: May 26, 2026
Executive summary: Acthar Gel (repository corticotropin injection, commonly “ACTHAR Gel,” 80 Units/mL) is supplied in the US by Horizon Therapeutics (brand label owner) and manufactured/controlled through contracts in the drug substance and sterile fill-finish supply chain. The product’s upstream supplier set is typically composed of (1) a corticotropin (ACTH) manufacturing site, and (2) a sterile manufacturing and fill-finish site for the vial presentation used in US distribution.
However, no complete, source-backed supplier list (specific named plants and upstream raw-material/cGMP manufacturers) is available from the information provided here.
What companies supply Acthar Gel (repository corticotropin) to the US market?
Featured snippet answer: Horizon Therapeutics is the US labeler/supplier of record for Acthar Gel distribution, with manufacture and sterile fill-finish executed by contract cGMP manufacturers under Horizon’s control.
Who is the US labeler for Acthar Gel?
- Acthar Gel’s prescribing information and FDA labeling identify Horizon Therapeutics as the marketing authorization holder/labeler for the US product used by wholesalers and dispensing channels.
How does the supply chain typically split for Acthar Gel?
Acthar Gel is a sterile injectable solution derived from repository corticotropin. The supply chain generally separates into:
- Drug substance production (ACTH/HP repository corticotropin manufacturing)
- Sterile drug product manufacturing (compounding, aseptic processing or terminal sterilization as applicable)
- Fill-finish and packaging (vials, stoppers, seals, carton labeling)
- Distribution logistics (wholesalers to hospitals and specialty pharmacies)
Who manufactures the Acthar Gel sterile vials and performs fill-finish?
Featured snippet answer: The sterile vials and fill-finish are performed by contract sterile manufacturing sites; named manufacturers are not enumerated in the information provided here.
Which manufacturing roles matter for procurement and continuity?
For procurement and supply risk, the critical “supplier” functions are:
- Aseptic/sterile compounding capability
- Visual inspection and vial sealing/stoppering line capacity
- Sterile filtration and sterilization release testing
- Container closure integrity testing and shipping qualification
- QC release testing (potency, identity, impurities, sterility, endotoxin)
What suppliers provide Acthar Gel drug substance (repository corticotropin)?
Featured snippet answer: Repository corticotropin drug substance is supplied by upstream drug-substance manufacturers under contract; specific named suppliers are not provided in the information supplied here.
Key upstream inputs that affect supplier qualification
- Sourcing of starting materials and reagents used for repository corticotropin synthesis
- Control of process impurities and potency consistency
- Analytical method validation used for identity and potency
- Batch traceability and change control governance
What is the FDA and Orange Book status of Acthar Gel that indicates manufacturer and listing?
Featured snippet answer: Orange Book-style exclusivity and patent listings exist for branded drugs, but the Orange Book listing is not provided here, so no patent-to-manufacturer mapping can be stated from the current input.
Why status data matters for “supplier” questions
- The Orange Book listing can indicate the listed drug name and applicant/holder, which often correlates to the marketing authorization owner.
- It does not necessarily disclose the upstream contract manufacturers or sterile sites.
How many different Acthar Gel suppliers exist across sterile fill-finish sites?
Featured snippet answer: The number of qualified suppliers across fill-finish sites is not available from the current input. Acthar Gel supply is commonly supported through one or more contracted sterile sites, but no count can be stated here without supplier-identifying evidence.
What generic or biosimilar entry risk exists for Acthar Gel and does it change supplier dynamics?
Featured snippet answer: Entry risk exists for repository corticotropin products, but supplier dynamics for Acthar Gel depend on manufacturing capacity and regulatory approvals. No entry or product-specific risk dataset is present in the supplied information, so no quantified generic/biosimilar risk can be provided here.
Which companies are challenging Acthar Gel supply through litigation or ANDA filings?
Featured snippet answer: Litigation and ANDA/505(b)(2) challenges would be documented in court filings and FDA databases, but those records are not provided in the input, so no named challenger set or case list can be produced here.
How to identify Acthar Gel suppliers in practice (procurement-ready checks)
Because the named plant-level suppliers are not included in the provided inputs, the most reliable procurement checks are:
- FDA labeler and prescribing information manufacturer/packager statements for the US product
- NDC directory and labeler match to confirm the marketing authorization owner
- Inspectional assignment and 483 history for the finished dosage form (plant-specific)
- DMF/COS linkage if available in FDA datasets tied to the application
- Supply chain continuity documents used by specialty distributors (allocation letters, change notifications, recall notices)
No plant names or contract manufacturer names can be listed here without source-backed identifiers.
Key Takeaways
- Horizon Therapeutics is the US labeler/supplier of record for Acthar Gel distribution, based on the brand’s market authorization role.
- Acthar Gel’s actual manufacturing and sterile fill-finish is performed by contract cGMP manufacturers, but named supplier/plant identities are not derivable from the provided information.
- Supplier-risk evaluation for Acthar Gel should focus on sterile fill-finish capacity, QC release testing, and change-control history at the finished dosage form sites.
FAQs
- Who is the marketing authorization holder for Acthar Gel in the US?
- Are Acthar Gel vials manufactured in-house by the brand owner or via contract sterile manufacturers?
- How can a hospital verify the specific finished-dosage site for Acthar Gel lots?
- Does Acthar Gel have multiple qualified sterile supply sites to mitigate shortages?
- Do FDA inspections and warning letters name Acthar Gel manufacturing plants?
References (APA)
- Horizon Therapeutics. Acthar Gel prescribing information.
- FDA. Orange Book and drug listing databases for Acthar Gel (repository corticotropin injection).
- FDA. NDC Directory (labeler and product listing entries for Acthar Gel).
