Suppliers and packagers for generic pharmaceutical drug: CORTICOTROPIN

CORTICOTROPIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372	NDA	Mallinckrodt ARD LLC	63004-8710-1	1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE	2013-01-07
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372	NDA	Mallinckrodt ARD LLC	63004-8710-2	1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE	2013-01-07
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372	NDA	Mallinckrodt ARD LLC	63004-8711-4	4 TRAY in 1 CARTON (63004-8711-4) / 1 SYRINGE in 1 TRAY (63004-8711-1) / 1 mL in 1 SYRINGE	2024-02-29
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372	NDA	Mallinckrodt ARD LLC	63004-8712-4	4 TRAY in 1 CARTON (63004-8712-4) / 1 SYRINGE in 1 TRAY (63004-8712-1) / .5 mL in 1 SYRINGE	2024-02-29

Suppliers for Corticotropin: Who Manufactures, Supplies, and Licenses Corticotropin Products in the US and EU

Last updated: May 25, 2026

Corticotropin is a peptide drug used for select indications (notably infantile spasms in the US historical landscape and other endocrine indications depending on product labeling). Supplier coverage is product-form and geography dependent. The supply chain for “corticotropin” is concentrated around the originators and their contract manufacturing partners, with downstream availability shaped by FDA approvals (where applicable), Orange Book listings, and ongoing GMP supply.

H1: Suppliers for Corticotropin (ACTH): Manufacturing Companies, Contract Manufacturers, and Market Entrants

Which companies are suppliers for corticotropin (ACTH) products?

The “corticotropin” supplier landscape is best mapped at the product level (brand vs. generic-equivalent) because the drug substance and the final sterile drug product can be sourced from different sites. In practical procurement terms, purchasing is tied to the specific FDA-approved product and its labeled strength and dosage form.

What supplier categories exist for corticotropin?

• US FDA-approved sponsor/marketing authorization holder for the finished sterile drug product (controls branded supply and label-specific manufacturing).
• Contract manufacturing organizations (CMOs) producing sterile peptide vials for the finished dosage form under sponsor control.
• Drug-substance makers supplying peptide intermediates or bulk peptide to sterile-fill finishers.
• Distributors and wholesalers (limited number of SKUs, but multiple channels in practice).
• Parallel EU importers (where applicable to member-state supply).

Core point for procurement

When “corticotropin suppliers” are evaluated for contracting, the binding question is: which entity controls release testing, sterile manufacturing site qualification, and product-specific regulatory compliance. That entity is typically the marketing authorization holder (or its direct contract with a releaser-distributor framework).

What are the main corticotropin product names and who supplies them?

Corticotropin is commonly associated with ACTH products sold historically and in modern markets under branded naming conventions. Supplier identification depends on which labeled product you mean.

Product-level supplier mapping (how to structure vendor due diligence)

Procurement due diligence for corticotropin should be structured as:

1. Finished product marketer/sponsor
2. Sterile fill-finish site (GMP release site)
3. Drug substance sourcing (peptide synthesis sites)
4. Distribution network (primary wholesaler relationships)
5. Availability constraints (short production campaigns, batch release timing)

How does corticotropin supply differ by strength, vial size, and dosage form?

Corticotropin supply is not fungible across packaging and dose presentation. A vial strength and container closure system affect:

• sterile compounding compatibility in institutional settings
• cold-chain and stability logistics
• batch size economics and release testing throughput

Procurement impact

Even if two suppliers are both “corticotropin,” only the one matching the purchasing SKU (strength, vial count, label) qualifies for substitution in tenders and formularies.

Which manufacturers control sterile fill-finish for corticotropin?

Sterile fill-finish for injectable peptide products is typically constrained to qualified aseptic processing suites with validated cycle parameters for peptide integrity and sterility assurance.

Vendor qualification checklist for sterile peptide injectables

• aseptic processing qualification status for peptide formulations
• container closure integrity validation for the vial
• peptide adsorption mitigation strategy (materials compatibility)
• in-process controls and batch release testing scope
• historical sterility failure rate and deviation reporting cadence

What contract manufacturers make corticotropin for sponsors?

For peptide injectables, CMOs often run batch manufacturing and sterile filling under sponsor-controlled quality systems. Supplier visibility at this layer tends to be:

• publicly visible via manufacturing information in regulatory filings (for sponsors)
• partially visible via inspection reports and corporate manufacturing listings
• reinforced through quality agreements and supply contracts rather than public catalogs

How to identify CMO suppliers operationally

The most reliable supplier determination in practice uses:

• sponsor’s documented manufacturing sites in regulatory submissions
• GMP certificate of analysis and batch release documentation provided in vendor onboarding
• supplier audits tied to the exact manufacturing site listed for the SKU

Which raw material and drug-substance suppliers feed corticotropin production?

Drug substance for corticotropin is peptide-based. The supplier layer typically includes:

• peptide synthesis and purification at specialized chemical manufacturing sites
• bulk intermediate supply to sterile manufacturing partners
• QC analytics vendors supporting identity, purity, potency assays

Supply-chain constraints for peptide drug substance

Peptide synthesis supply is sensitive to:

• custom synthesis capacity windows
• impurity profile control and lot acceptance rates
• availability of GMP-compliant analytical reagents and reference standards

What are the Orange Book implications for corticotropin suppliers and distributors?

Orange Book status is product-specific. For a “supplier” question, Orange Book listings matter because they:

• identify the approved NDA holder for the listed drug product
• can signal whether there is a pathway for substitution or generic-equivalent supply
• help map which company owns the regulatory gatekeeping for that exact SKU

When do corticotropin supply constraints arise, and who is exposed?

Corticotropin supply risk tends to be driven by:

• limited batch sizes for sterile peptide injectables
• QC release timing and sterility assurance pressures
• single-site dependence for fill-finish or drug substance synthesis

Exposure mapping

• Sponsor/marketing authorization holder exposure: supply continuity and FDA compliance.
• Distributor exposure: allocation and substitution pressure on institutions.
• CMO exposure: capacity and deviation-driven holds.
• Healthcare provider exposure: formulary interruption and procurement lead-time spikes.

What biosimilar or generic entry risks exist for corticotropin suppliers?

Corticotropin is a small peptide drug. “Biosimilar” frameworks apply to biologics; generic frameworks apply to chemically synthesized or approved small-molecule/generic-equivalent categories. Supplier decisions should be aligned to the regulatory classification of the specific corticotropin product and its approved pathway.

Practical supplier risk

• If a generic equivalent exists for the specific SKU, supplier diversification increases.
• If the market is tightly held by a limited number of approved manufacturers, supplier risk stays concentrated.

How does corticotropin compare with ACTH products in the supplier market?

Market suppliers may consolidate around “ACTH/corticotropin” brand families that share manufacturing approaches but not always the same product presentation. Procurement comparisons must consider:

• whether the supplier can deliver the exact labeled SKU
• the regulatory listing tied to that SKU
• whether substitution is allowed under the facility’s pharmacy policy

Which licensing deals and manufacturing agreements shape corticotropin supply?

Licensing and manufacturing agreements typically govern:

• who is allowed to manufacture under the NDA holder’s quality system
• branded marketing rights by territory
• post-approval manufacturing site changes and tech transfer

Commercial takeaway

Supplier reliability for corticotropin is often less about who can synthesize peptide and more about who can do the sterile drug product finish under the right regulatory framework for the specific NDA or marketing authorization.

Key supply decision criteria for corticotropin vendors

Procurement and partnership decisions should be anchored to:

• regulatory-defined manufacturing site for the SKU (release responsibility)
• quality system maturity for sterile peptide injectable products
• supply continuity record (allocation events, batch failure history)
• analytical capability for potency and impurity profile control
• lead time and batch campaign structure

Key Takeaways

• Corticotropin “suppliers” are best identified at the specific finished SKU level, not as a generic category.
• The controlling supplier is typically the marketing authorization holder, with CMOs responsible for sterile fill-finish and sometimes drug substance.
• Supply risk is concentrated around limited sterile manufacturing capacity and QC release timing for peptide injectables.
• Orange Book and label-specific regulatory status are central to mapping who can supply substitutable product.

FAQs

1) Who can supply corticotropin vials for hospitals under US purchasing rules?
Answer: Suppliers must match the exact labeled SKU and regulatory listing for the product the hospital formulary authorizes.

2) What should a CMO be able to demonstrate to manufacture corticotropin sterile injectables?
Answer: Aseptic processing qualification, peptide formulation compatibility, container closure integrity, and release testing under GMP.

3) Are corticotropin formulations interchangeable across vial strengths and pack sizes?
Answer: No. Procurement substitution is limited by labeled strength, vial count, and packaging.

4) How do manufacturing site changes affect corticotropin supply?
Answer: Tech transfer and regulatory updates can create temporary supply constraints and require batch-specific release validation.

5) What drives shortages for peptide injectable drugs like corticotropin?
Answer: Single-site dependence for sterile fill-finish, QC release bottlenecks, and deviation-driven batch holds.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). US Food and Drug Administration. (Accessed via FDA Orange Book).
2. EMA European Public Assessment Reports (EPAR) and European Medicines Agency product pages for ACTH/corticotropin-containing medicinal products. European Medicines Agency. (Accessed via EMA).