Last updated: May 29, 2026
ROWASA (mesalamine) supplier landscape: who manufactures, supplies, and controls distribution in the US
ROWASA (mesalamine) is an oral/rectal 5-ASA product supplied for ulcerative colitis. The supplier landscape is determined by (1) the NDA holder that controls labeling and distribution, (2) the contract manufacturer(s) producing drug substance and drug product, and (3) any authorized distributors and wholesaler networks used for US fulfillment.
No complete, citable supplier list with named manufacturers for ROWASA drug substance, finished dosage form, and labeled US supply chain is provided in the available information.
What companies supply ROWASA (mesalamine) in the US market?
Featured snippet answer: The market supplier(s) for ROWASA are the NDA holder and any contract manufacturers producing and/or packaging the finished rectal product, supported by authorized distribution channels.
Which entities typically appear as ROWASA suppliers
- NDA holder that controls label ownership and FDA regulatory reporting
- Contract manufacturing organizations (CMOs) for drug product (formulation, fill-finish, labeling, packaging)
- Upstream suppliers for mesalamine drug substance
- Wholesalers and logistics partners used for national distribution
What prevents a named supplier map here
A named supplier map requires a source-backed dataset (e.g., FDA Drugs@FDA “Applicant/Manufacturer” fields, Orange Book “Manufacturing Site,” label section “Manufactured for/Distributed by,” or corporate filings). That information is not present in the provided input, so a supplier roster cannot be produced without risking factual error.
Who manufactures ROWASA 4 g/60 mL enema and how is it packaged?
Featured snippet answer: The manufacturer of the ROWASA enema is the labeled “Manufactured for/Distributed by” entity and the underlying manufacturing site(s), which are typically shown on the package label and in FDA listing records.
Dosage form and packaging dependencies
ROWASA is a rectal enema presentation; supplier identity can differ across:
- primary container and closure system
- carton/labeling and lot distribution
- different manufacturing sites for the same labeled product
Why a manufacturer-by-manufacturer list is missing
No ROWASA label or FDA listing data is included in the available content, so the exact manufacturer(s) and fill-finish site(s) cannot be stated.
What is the Orange Book status of ROWASA and what does it imply for suppliers?
Featured snippet answer: Orange Book listings identify NDA and relevant product patents and exclusivity, but do not always enumerate the full CMO network. Supplier identification still requires label or FDA manufacturing-site records.
Orange Book does not fully replace supplier sourcing
Even when an Orange Book record exists, supplier mapping to:
- drug substance (mesalamine)
- intermediate materials
- fill-finish and packaging
- contract logistics
often requires label and establishment-level manufacturing details.
No Orange Book record provided
No Orange Book record details (application number, listed drug, manufacturing sites) are included here.
Are there ROWASA generics or authorized alternatives that change the supplier ecosystem?
Featured snippet answer: Competition and supply continuity can shift supplier pressure, but identifying alternatives requires knowing ROWASA’s current regulatory and market status.
How alternatives typically affect supply
- Generics reduce leverage of original sourcing and can add CMOs across competitors
- Authorized generics or relabeled products can route through different manufacturers and packaging facilities
- Temporary shortages can trigger re-labeled supply from alternate sites, changing “supplier” even when the labeled company is constant
No competitor/regulatory status included
The provided input does not contain information on generics, shortages, or authorized alternatives.
How do you identify the actual ROWASA supplier from FDA label language and Drugs@FDA fields?
Featured snippet answer: Use the ROWASA package label “Manufactured for” / “Distributed by” sections and the Drugs@FDA/NDC records that list applicant/manufacturer and establishment information.
Typical data fields used in supplier attribution
- Drugs@FDA application “Applicant” and “Manufacturer”
- FDA listing for the NDC that includes labeler and manufacturing site
- Package insert and carton label “Manufactured for/Distributed by”
- FDA establishment registration or site-specific cGMP data (where available)
No label or NDC-level record is included
Without the ROWASA NDC or label text in the provided material, the required fields cannot be extracted.
Key Takeaways
- ROWASA supplier identification depends on label “Manufactured for/Distributed by” entities, plus FDA listing and manufacturing site records.
- The provided information does not include the FDA label, Drugs@FDA, Orange Book, or NDC establishment fields needed to name specific ROWASA suppliers.
- A named supplier list cannot be produced without introducing factual risk.
FAQs
- What does the ROWASA enema label say about “Manufactured for” vs “Distributed by”?
- How do I find the ROWASA NDC and use it to trace FDA manufacturing-site data?
- Do ROWASA shortages cause alternate manufacturing sites or relabeled supply?
- Can mesalamine drug-substance suppliers differ from finished-product enema manufacturers?
- How do generics and shortages change which companies supply rectal mesalamine in the US?
References
- FDA. Drugs@FDA database. (Accessed via provided content not included).
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via provided content not included).
