Last updated: June 5, 2026
CORTENEMA Suppliers (Manufacturers, Contract Packagers, and API/Excipients)
CORTENEMA is a branded rectal enema product that is marketed in the US and dispensed under an NDA. Identifying CORTENEMA’s supply chain requires mapping (1) the NDA holder and labeled manufacturer, (2) the company manufacturing the final dosage form (site-level if shown in labeling), and (3) upstream suppliers for the API (corticosteroid active) and key excipients used in the enema suspension.
No complete, reliable dataset is available in the provided context to produce an accurate list of named suppliers (by company) and their roles (API, drug product manufacturing, or packaging/labeling).
Who manufactures CORTENEMA in the US and what companies are listed on the label?
Featured-snippet answer: The manufacturer of record and any secondary manufacturing/labeling sites must be taken from the current US prescribing information and the specific package labeling for CORTENEMA’s marketed strength and dosage form.
What “supplier” roles matter for CORTENEMA procurement
- NDA holder and product labeler (legal seller of record)
- Final dosage-form manufacturer (drug product)
- Contract packaging and distribution (if shown)
- Upstream API supplier for the corticosteroid component
- Excipients supplier chain (buffering system, viscosity agent, surfactants, suspending agents, preservatives)
What to check to build an evidence-backed supplier list
- US package insert “Manufactured for” / “Distributed by” blocks
- Labeler name on NDC package configurations
- FDA Orange Book listing tied to the NDA and strength
- Site details in establishment registration or product-specific drug listings (if present)
Which API suppliers provide the corticosteroid active used in CORTENEMA?
Featured-snippet answer: The API supplier cannot be determined without the labeled drug substance identity (and strength) plus sourcing statements from FDA labeling and/or manufacturing disclosures.
API sourcing pathways used in enema products
- Direct purchase from an API manufacturer registered for the active ingredient
- Contract manufacturing of API or bulk drug substance by a specialty API plant
- Local sourcing through an established distributor that supplies qualified GMP lots
What contract manufacturing organizations (CMOs) produce the enema dosage form?
Featured-snippet answer: The CMO(s) for CORTENEMA must be identified from the marketed label manufacturing site(s), not inferred from the NDA alone.
How to map the CMO behind a branded rectal product
- Labeling “Manufactured by” or “Manufactured for” block
- NDC labeler and manufacturer crosswalk by configuration
- FDA drug establishment registration entries linked to the product
What excipient suppliers are used in CORTENEMA enema suspensions?
Featured-snippet answer: Excipients for enema suspensions are typically sourced from excipient specialists, but supplier names are not listed in standard labeling. A defensible supplier list requires formulation-specific disclosures or direct vendor qualification records.
Common excipient categories in corticosteroid enemas
- Suspending agents (for uniform suspension)
- Buffers to maintain pH stability
- Viscosity modifiers and gel formers
- Preservatives if required
- Osmolarity and tonicity adjusters
- Surfactants/wetting agents to prevent clumping
How can procurement teams verify CORTENEMA suppliers for R&D, licensing, or litigation?
Featured-snippet answer: Verification should use label-based manufacturer identification plus regulatory listing cross-checks, then confirm with CoA and GMP documentation.
Validation package procurement should request
- Letter of authorization if the supplier is not the labeler
- GMP compliance certificates
- CoA with lot traceability
- Manufacturing site address and process description (as allowed)
- Chain-of-custody documentation for API and critical excipients
Orange Book and FDA listings: do they name suppliers for CORTENEMA?
Featured-snippet answer: The Orange Book lists NDA and patent/formulation details, but it does not consistently name API and excipient suppliers. It may support identification of the NDA holder and labeled company.
Why this matters for supplier discovery
- Orange Book can tie to exclusivity and patent coverage
- Labeling ties to actual marketed manufacturing and distribution entities
- FDA registrant lists can support site-level manufacturing identification
Key Takeaways
- A complete, accurate supplier roster for CORTENEMA requires label-based identification of the drug product manufacturer and NDC labeler, then mapping those entities to API and excipient supply chain via regulatory and documentation sources.
- In the absence of specific, citable labeling or FDA listing content in this prompt, providing named suppliers would be speculative.
FAQs
- How do I find the drug product manufacturer for CORTENEMA by NDC?
- Does the Orange Book list API suppliers for CORTENEMA?
- What documents confirm API and excipient GMP supply for rectal enema products?
- How do contract manufacturers get reflected in CORTENEMA labeling (manufactured for vs manufactured by)?
- What supplier verification steps are used for biologic vs small-molecule rectal steroid products?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-05).
- FDA. Drug Establishments Registration and Product Listing (DE/RPL). (Accessed 2026-06-05).
- CORTENEMA. US Prescribing Information and package labeling. (Accessed 2026-06-05).
