Last updated: June 1, 2026
Executive summary: ACTHAR GEL (repository corticotropin injection; autoinjector) is supplied through ANI Pharmaceuticals’ commercialization model in the U.S. end market, with key manufacturing and supply-chain steps historically split across: (1) raw-material and peptide API/biologic upstream supply, (2) drug-product manufacturing for the gel, (3) fill-finish in final container closure systems, and (4) autoinjector platform sourcing and assembly. Without the underlying contract-manufacturer assignment list (drug substance, drug product, and device partners) and the latest FDA Drug Master File (DMF) and manufacturing-site references, a complete, verifiable supplier roster cannot be produced from the information available in this prompt.
What suppliers make Acthar Gel (autoinjector) drug product and device components?
Answer: ACTHAR GEL autoinjector supply involves at least four supplier layers: drug substance/biologic upstream, sterile drug-product manufacturing, fill-finish into the final container, and autoinjector device platform components. A complete named roster requires cross-referencing the current U.S. label manufacturing section, FDA facility databases, and any listed device platform source used for ACTHAR’s autoinjector configuration.
Drug substance/biologic upstream supply
- Upstream biologic production and purification for repository corticotropin injection typically sits with a specialized biologics supplier.
- For ACTHAR specifically, the upstream supplier identity must be taken from the current FDA label “Manufactured for/by” and/or associated CMC references tied to the marketed presentation.
Sterile drug-product manufacturing for the gel
- Sterile manufacturing typically includes compounding, filtration/sterilizing strategies (as applicable), aseptic filling controls, and final packaging.
- The only supplier names that can be asserted with defensible precision are those listed in the current prescribing information “Manufactured for” / “Manufactured by” blocks.
Fill-finish into final container closure system
- Fill-finish is usually at a dedicated sterile facility with validated aseptic processing lines.
- Supplier identification depends on the specific NDC presentation tied to the autoinjector.
Autoinjector platform sourcing
- Autoinjector devices are commonly sourced from device platform vendors or integrated device contract manufacturers.
- Supplier identification depends on the device used for the autoinjector presentation and the packaging and assembly descriptions in the label and inspectional history.
Which companies supply the ACTHAR GEL autoinjector system used by patients?
Answer: The autoinjector platform supplier is part of the product’s final assembly ecosystem, but named vendor identification is not reproducible from the information provided in this prompt alone.
How autoinjector supply chains are typically structured
- Device platform manufacturer (spring drive, electronics-free needle safety mechanism, or mechanical safety system).
- Sterile drug cartridge/pen adapter integration, depending on design.
- Final device assembly and packaging at a contract manufacturer or at the marketer’s designated packaging sites.
Where to find supplier names in practice
- FDA label “Manufactured for” / “Manufactured by” sections for the autoinjector NDC.
- Facility identifiers linked to manufacturing/packing activities for the marketed NDC.
- DMF/CMC references that list cross-referenced manufacturing sites for drug product and sometimes device constituent components.
What FDA label manufacturing information identifies ACTHAR GEL autoinjector suppliers?
Answer: The current prescribing information is the controlling source for named “manufactured by” or “manufactured for” entities for each marketed presentation.
Label blocks that matter
- “Manufactured for” (marketer and sometimes device assembly or packaging responsibility).
- “Manufactured by” (drug-product manufacturing site).
- “Packaged by” (if separately listed).
- Storage/handling and container descriptions that map to the autoinjector NDC.
How can you map ACTHAR GEL autoinjector suppliers to specific NDC presentations?
Answer: Supplier attribution must be done by NDC, not by brand name alone.
Why NDC mapping is necessary
- Multiple dosage forms and packaging configurations can exist under the ACTHAR brand.
- Autoinjector presentations can have distinct fill-finish and packaging sites compared with vials.
Mapping workflow used by patent and regulatory counsel
- Match the autoinjector presentation to its NDC(s).
- Pull each NDC’s label “Manufactured for/manufactured by” entries.
- Cross-check with FDA facility databases for the exact manufacturing and packaging activities associated with that NDC.
Do third-party suppliers provide ACTHAR GEL raw materials and biologic components?
Answer: Yes, ACTHAR’s repository corticotropin is a biologic-derived drug, so upstream raw-material and biologic manufacturing supply typically involves third parties or internal biologics divisions with specialist capabilities. Named suppliers must be validated against the current regulatory filings and label entity list.
Common upstream supplier categories
- Raw-material sourcing for biologic manufacturing inputs.
- Specialized purification and characterization inputs.
- Sterile filtration components and sterile consumables used in aseptic processing.
Which contract manufacturers perform fill-finish and packaging for ACTHAR GEL?
Answer: Fill-finish and packaging are typically executed at specialized sterile facilities, but named contract manufacturers for ACTHAR must be taken from the current autoinjector label and the site-specific manufacturing history for the autoinjector NDC.
What you can infer from U.S. manufacturing models
- Sterile biologic fill-finish is commonly handled by GMP aseptic filling sites.
- Packaging is often split from drug substance manufacturing, and sometimes split again across device assembly and final cartons/leaflets.
What autoinjector device vendors are used in ACTHAR GEL (autoinjector) product assembly?
Answer: Named autoinjector device vendors must be confirmed from label/device package inserts or device registration details tied to the specific marketed presentation.
Device supplier identification risks
- Device vendors can change across production lots, platform generations, or contract renewals.
- Supplier identification must be anchored to the current marketed configuration for the autoinjector NDC.
Key Takeaways
- ACTHAR GEL autoinjector supply involves a layered ecosystem: biologic upstream supply, sterile drug-product manufacturing, fill-finish, and autoinjector platform sourcing and assembly.
- Supplier names that can be stated with authority must come from the current prescribing information “Manufactured for/manufactured by/packaged by” sections tied to the autoinjector NDC.
- Supplier mapping should be done at the NDC level, not at the brand level.
FAQs
- Which NDC(s) correspond to ACTHAR GEL autoinjector presentations?
- What does the ACTHAR GEL autoinjector label list under “Manufactured for” and “Manufactured by”?
- Are the autoinjector device assembly and final packaging performed by the same supplier as drug-product manufacturing?
- Do ACTHAR GEL suppliers differ between vial and autoinjector presentations?
- How do you identify autoinjector device platform suppliers from FDA or label documentation?
References
(References not provided because no source documents, label text, NDC list, or FDA manufacturing-site records were included in the prompt.)
