Last updated: April 25, 2026
Who Supplies Uceris (Budesonide) in the Pharmaceutical Supply Chain?
Uceris is the brand name for budesonide used for ulcerative colitis. In practice, “suppliers” typically split into two layers: (1) manufacturers of the finished dosage form (the drug product under the brand), and (2) suppliers of key components (active pharmaceutical ingredient and critical excipients).
No complete, defensible list of specific suppliers can be produced from the information provided. A correct supplier map requires at minimum one of the following: the NDA/ANDA labeling-level manufacturer for Uceris drug product, the DMF/ASMF holders for the budesonide API, or FDA inspection/DMF cross-references tied to Uceris manufacturing sites. Without that, any named supplier list would be speculative.
What can be stated from the product context
- Active ingredient: budesonide (corticosteroid)
- Drug class: inhaled/oral glucocorticoid corticosteroid portfolio (for Uceris specifically, used for inflammatory bowel disease)
- Brand drug product: marketed as Uceris (extended-release formulation for ulcerative colitis)
What cannot be safely enumerated here
- Specific drug product manufacturing suppliers for Uceris tablets/granules/packaging
- Specific budesonide API suppliers
- Specific excipients or supplier sites used in Uceris formulations
- Specific contract manufacturing organizations (CMOs) tied to Uceris batches
Why supplier identification requires site- and filing-level data
A “supplier” list that holds up in due diligence must tie to one of these verifiable anchors:
- FDA label “Manufactured for” / “Distributed by” sections (for finished dose)
- Orange Book application holder and listed manufacturers (for drug product)
- DMF/ASMF references linked to budesonide source and formulation components
- Inspection history for the labeled manufacturing sites
Without these anchors, the supplier names cannot be validated to Uceris specifically.
Key Takeaways
- Uceris is budesonide for ulcerative colitis, but identifying named suppliers requires label-level and filing-level manufacturing data.
- The information provided does not include the label manufacturer, Orange Book listed manufacturers, or DMF/ASMF cross-references needed to build a defensible supplier map.
- Any attempt to list suppliers by name without those anchors would not meet due-diligence standards.
FAQs
1) What is Uceris?
Uceris is a branded budesonide product used for ulcerative colitis.
2) What does “supplier” mean for a branded drug like Uceris?
It usually refers to the finished dose manufacturer and, separately, API and excipient suppliers used in production.
3) Can I identify Uceris suppliers from the brand name alone?
Not reliably. Supplier identification requires the drug product label manufacturing/distribution statements and/or Orange Book and DMF/ASMF-linked manufacturing sites.
4) Where do defensible Uceris supplier names come from?
From FDA labeling, Orange Book manufacturing entries, and DMF/ASMF references tied to the exact Uceris product and dosage form.
5) Why is API supplier identification harder than brand-level manufacturing?
Budesonide API sources are typically managed through DMFs/ASMFs and can change across time, necessitating application- and site-level records.
References
[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Uceris entry and application details).
[2] FDA. Drug Labeling for Uceris (budesonide): manufacturer and distribution statements.
[3] FDA. DMF/ASMF database and DMF references linked to budesonide applications (site and reference relationships).
