Last updated: June 3, 2026
Cortrosyn Suppliers: Who Manufactures Corticotropin and Where Are They Listed?
Cortrosyn (corticotropin) sourcing is dominated by a small set of branded and generic manufacturers with drug-substance and finished-dose capabilities. A definitive supplier map for the US market depends on the FDA-labeling and Orange Book/agency listing for the exact marketed presentation and strength.
Who supplies Cortrosyn corticotropin in the US market?
Cortrosyn is supplied as corticotropin (ACTH) for diagnostic and therapeutic use depending on label. In practice, “suppliers” split into two operational layers:
- Labeler of record / finished-dose manufacturer (who releases Cortrosyn to wholesalers and hospitals).
- Drug-substance and manufacturing partners (API and fill-finish, often with contract manufacturing).
For actionable procurement and competitive intelligence, the correct approach is to tie the supplier identity to the specific FDA-listed product (strength and dosage form) and its Orange Book listing.
What drug substance supplies support Cortrosyn manufacture?
Corticotropin manufacturing is typically constrained by:
- reference-standard handling and potency assays,
- sterile manufacturing capacity for injectable ACTH,
- analytic controls for glycoprotein/peptide composition and bioactivity,
- cold-chain distribution requirements.
How do wholesalers source Cortrosyn?
Wholesalers generally source through:
- direct distribution agreements from the labeler of record, and
- secondary sourcing through authorized distributors for shortages.
What manufacturers produce corticotropin products that compete with Cortrosyn?
Corticotropin competes as:
- branded corticotropin products with similar indication language, and
- generic corticotropin products approved via FDA pathways appropriate to the reference listed drug and dosage form.
From a sourcing standpoint, any “Cortrosyn-like” injectable corticotropin must be checked against:
- the exact strength,
- the route (injectable),
- and whether it is therapeutically equivalent under FDA labeling.
Generic corticotropin suppliers
Generic injectable corticotropin supply is typically concentrated among manufacturers with sterile injectable capability and validated potency systems. The practical supplier list is derived from:
- FDA’s drug product listing (labeler/manufacturer details), and
- the Orange Book’s corresponding strength/dosage form listing.
What is the Orange Book status of Cortrosyn corticotropin?
Orange Book status determines which generic applicants can reference the product and where exclusivity and patent barriers may constrain supply.
Orange Book fields that matter for supplier identification
For each Cortrosyn strength/dosage form, Orange Book provides:
- active ingredient and dosage form,
- applicant/holder tied to the FDA listing,
- listed patents and expiration dates,
- exclusivity blocks that affect generic entry timing.
A supplier map for Cortrosyn is therefore compiled by linking:
- the FDA labeler for the Cortrosyn listing to the
- Orange Book applicant/holder and any approved generic entries for that same RLD.
When do generic Cortrosyn entrants risk supply gaps or launch-driven shortages?
Supply risk is driven by:
- contract manufacturing slots and sterile capacity,
- API availability and potency assay throughput,
- regulatory maintenance obligations,
- and market concentration in a limited number of sterile ACTH-capable plants.
A generic launch can tighten supply if:
- the reference product’s manufacturer diverts capacity,
- a second source is delayed by inspection or process changes,
- or distribution agreements change during shortages.
Which companies are likely to be Cortrosyn suppliers by FDA listing and dosage form?
A complete, litigation-grade supplier list requires product-by-product FDA listing extraction by:
- active ingredient: corticotropin,
- route: injectable,
- strength: per vial/ampule presentation,
- and dosage form: solution for injection.
Without tying to the exact FDA product listing for “Cortrosyn” and its specific strength, any named manufacturer list risks mixing:
- different corticotropin presentations,
- different labeler-of-record products,
- and non-substitutable ACTH comparators.
Cortrosyn supplier due-diligence checklist for procurement and contracting
To confirm supplier fit for hospitals, distributors, or payers:
- Match the FDA labeler of record to the procurement SKU.
- Confirm NDC and presentation (vial size, strength).
- Validate that the supplier can meet:
- cold-chain requirements,
- lead times,
- and batch-level availability.
- Check the Orange Book listing for the referenced RLD to understand generic substitution pressure and potential price changes.
- Review any FDA warning letters/consent decrees affecting sterile injectable production at the manufacturing site.
Key Takeaways
- “Cortrosyn suppliers” must be defined by the exact FDA-listed Cortrosyn strength and dosage form, because corticotropin sourcing differs by presentation.
- Orange Book status is the controlling framework for identifying the labeler/applicant tied to the reference listed product and for mapping competitive generics that affect supply.
- Supplier concentration risk is common in sterile injectable biologically active products like corticotropin, so procurement should anchor to NDC-level verified sourcing.
FAQs
What NDCs correspond to Cortrosyn and who are the labelers?
NDC-level verification is required because different strengths and presentations can have different labelers and manufacturing sites.
Is Cortrosyn available from multiple manufacturers in the US?
Availability depends on whether FDA has approved generic or follow-on versions for the same RLD and presentation.
What affects corticotropin supply during shortages?
Sterile injectable capacity, potency assay throughput, API lot release, and cold-chain logistics.
Can pharmacies substitute a generic corticotropin for Cortrosyn?
Substitution is constrained by FDA-rated equivalence for the same strength/dosage form and by state pharmacy substitution rules.
Do patent and exclusivity barriers affect Cortrosyn supply?
They can delay generic entry, which can keep supply dependent on the reference product manufacturer until barriers expire or are cleared.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
- FDA. Drug Product Labeling and Structured Product Labeling (SPL) database. (Accessed via FDA SPL/NDC listings).
