Last updated: May 24, 2026
RHOFADE (eflornithine hydrochloride) is supplied through the U.S. prescription channel under Salix Pharmaceuticals/“Bausch Health” commercial ownership history, with manufacturing and distribution tied to branded-dermatology supply agreements. In the absence of specific, citable sourcing records tied to RHOFADE’s current FDA/Orange Book manufacturing site, label holder, and lot-distribution data, only supplier statements that are directly verifiable from published FDA labeling and listed manufacturer identities can be presented.
Who manufactures RHOFADE (eflornithine hydrochloride) for the U.S. market?
Answer: RHOFADE’s manufacturing is handled by the label’s listed manufacturer(s) for the marketed product strength and dosage form (topical cream). Supplier identification requires the FDA label’s “Manufactured for” / “Distributed by” lines or the FDA Orange Book “Applicant/Manufacturer” entries for the specific NDA. Without those published manufacturer lines being provided in the prompt, an exact supplier list cannot be stated.
What entities typically appear on RHOFADE labels as “manufactured for” or “distributed by”?
Common label patterns in U.S. branded dermatology products include:
- Labeler and marketing authorization holder (“Distributed by” or “Manufactured for”)
- Contract manufacturing organization (CMO) or internal manufacturing site (“Manufactured at”)
- Product distribution partner (often the same as labeler, sometimes separate)
What supplier types matter for RHOFADE procurement?
From a business procurement perspective, the relevant supplier categories are:
- NDA label holder (responsible party for regulatory labeling and product release under the NDA)
- CMO site (manufacturing, batch record execution, quality release support)
- Packaging supplier (tube/box components and labeling systems)
- Logistics distributor (wholesale distribution channels to wholesalers and specialty pharmacies)
What does the FDA Orange Book say about RHOFADE’s applicant and manufacturing sites?
Answer: The Orange Book lists the NDA applicant and provides listed patent and exclusivity data for the marketed product. It can also identify the NDA “Applicant” and manufacturer-related information tied to the approved product. A supplier list must be pulled from the specific NDA entry for RHOFADE, which is not provided in the prompt.
Why Orange Book manufacturing data is the cleanest supplier source
Orange Book data is structured for compliance:
- It ties the product to an NDA and labeler/applicant entity
- It can map to the approved product listing used by wholesalers and GPOs
- It supports litigation and licensing discovery because it is regulator-maintained
Who distributes RHOFADE to wholesalers and specialty pharmacies?
Answer: Distribution is performed under the labeler’s commercial organization and wholesale distribution model stated on the FDA-approved label (the “Distributed by” line). Without the label’s distributor identity included in the prompt, a specific distributor name cannot be stated.
What to look for in distributor language on the prescribing label
Procurement teams typically reconcile:
- “Distributed by” (U.S. commercialization entity)
- “Manufactured for” (labeler with regulatory responsibility)
- “Manufactured at” (site name and address)
- NDC packaging label details (tube size and imprint/lot identifiers)
Which suppliers support RHOFADE’s supply chain (API, excipients, and packaging)?
Answer: RHOFADE is formulated as a topical cream containing eflornithine hydrochloride. Supplier identities for API, key excipients, and packaging are only reliably determined by:
- FDA labeling “Manufactured at” and “Manufactured for” lines
- CMO vendor disclosures in regulatory submissions
- Public DS/DMF and site-name links from the NDA (not provided in the prompt)
API supplier disclosure: what exists publicly vs. what does not
- Public: company names and site addresses if explicitly listed on label/manufacturer lines.
- Often not public: API supplier identity unless included in label/manufacturing disclosures or linked DMFs with site names that are searchable and citable.
How does RHOFADE’s supply structure compare with other topical dermatology products?
Answer: Like most branded topical dermatology drugs, RHOFADE typically uses a labeler-managed supply chain with at least one CMO and one packaging line. Direct comparisons require product-specific label/manufacturer lines for each drug, which are not provided.
Typical competitive supply model in topical dermatology
- Brand labeler owns regulatory filing and commercial forecasting.
- One or more CMOs manufacture under batch-release arrangements.
- Packaging and labeling are outsourced to packaging contractors.
Key RHOFADE supplier findings (what can be stated from the prompt)
A precise list of named suppliers for RHOFADE (manufacturer/labeler/distributor, API source, and packaging suppliers) cannot be produced because the prompt does not provide:
- RHOFADE NDA number
- Orange Book applicant/manufacturer entries
- FDA label “Manufactured for/Distributed by/Manufactured at” lines
- NDC-specific labeler/manufacturer identifiers
Key Takeaways
- RHOFADE’s supplier identities must be pulled from the FDA-approved label (manufactured/distributed lines) and/or Orange Book listing tied to the specific NDA.
- Without the NDA/label manufacturer and distributor lines included in the prompt, a citable supplier roster cannot be generated.
- Procurement-grade supplier mapping for RHOFADE should reconcile labeler, CMO manufacturing sites, and NDC packaging labeler/distributor language.
FAQs
- What is the labeler and distributor name shown on the RHOFADE FDA prescribing label?
- Which manufacturing sites are listed for RHOFADE (eflornithine hydrochloride) on the package labeling?
- What is the NDA number and Orange Book applicant identity for RHOFADE?
- Do RHOFADE shortages typically originate from CMO manufacturing constraints or packaging bottlenecks?
- How should procurement teams validate supplier identity for RHOFADE batches (NDC, lot, and COA traceability)?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database accessed via RHOFADE-specific NDA entry required).
- FDA. Prescribing Information for RHOFADE (eflornithine hydrochloride) topical cream. (Label “Manufactured for/Distributed by/Manufactured at” lines required).
