Last updated: April 26, 2026
What is BUPHENYL and what supply chain label applies?
BUPHENYL is the brand name for sodium phenylbutyrate, a therapy used in urea cycle disorders. In commercial supply chains, sourcing typically splits into:
- Brand product supply (labeler and marketing authorization holder for the finished drug product)
- API and intermediate supply (sodium phenylbutyrate and upstream phenylbutyrate-related intermediates, depending on regulatory and manufacturing structure)
Who are the known finished-product supplier/labeler entities for BUPHENYL?
BUPHENYL is marketed by Recordati Rare Diseases in multiple markets (including the US). The completed-drug supply is tied to the product’s regulatory label and distribution.
US brand product label (BUPHENYL)
- Marketing authorization holder / labeler: Recordati Rare Diseases, Inc. (US label entity)
- Active ingredient: sodium phenylbutyrate
- Product name: BUPHENYL
What suppliers typically sit behind the finished product?
For BUPHENYL, supplier identification in practice depends on whether you mean:
- Regulatory labeler and distributor (named on packaging and in labeling documents)
- Manufacturer of record (often shown in labeling as “Manufactured for” or “Distributed by”)
- API supplier (rarely listed in consumer-facing labeling; typically disclosed only in confidential submissions or through DMF listings)
Because your request is for “suppliers,” the most auditable category is labeler/manufacturer of record as shown in regulatory labeling and product monographs.
BUPHENYL supply in the US: practical sourcing targets
Use the label entity as the starting point for procurement, contract manufacturing inquiries, or market-entry mapping:
Target procurement and compliance anchor
- Recordati Rare Diseases, Inc. (brand labeler for BUPHENYL in the US)
Supplier diligence map (what to verify in procurement)
- Confirm the manufacturer of record on current US packaging and latest prescribing information (PI)
- Confirm the commercial pack distribution entity named on the carton/label
- Confirm whether the supplied material is finished dose sodium phenylbutyrate formulation or if distributors route through regional packaging partners
BUPHENYL in cross-border supply: how global suppliers are usually structured
Across geographies, branded urea cycle disorder drugs often operate through:
- A central brand owner (labeler)
- Local distributors that clear regulatory import requirements
- A limited set of manufacturing sites that produce finished dose product for multiple markets
For BUPHENYL, the primary “supplier” anchor remains the brand labeler, with manufacturing site specifics typically confirmed via the most recent labeling and regulatory listings for each country.
Key market decision points for supplier selection
1) Regulatory labeler governs compliant procurement
If you are building an R&D comparability plan, or buying for clinical use, the labeler is the anchor for:
- product identity and equivalence
- batch traceability expectations
- substitution controls across lots
2) Procurement risk shifts to the manufacturing-of-record
Operationally, the biggest supply risk comes from:
- changes in manufacturer of record
- packaging configuration differences
- lead-time volatility tied to the drug product manufacturing site
3) API sourcing matters mainly for development work
If you are developing generics or doing formulation work, API and intermediate sourcing becomes central. Brand labeling usually does not disclose API vendors, so supplier identification relies on DMF systems and confidential regulatory dossiers.
What suppliers can be stated from available public labeling sources?
Based on publicly available US labeling entity information:
- Recordati Rare Diseases, Inc. is the key supplier/labeler entity for BUPHENYL in the US.
No additional finished-product manufacturer names are stated in the available excerpt-level public data provided here.
Key Takeaways
- BUPHENYL is sodium phenylbutyrate, and the most auditable “supplier” starting point in public sources is the US labeler: Recordati Rare Diseases, Inc.
- For actual contracting and supply reliability, procurement must validate the manufacturer of record named on current packaging and the latest US prescribing information.
- For API-level supplier identification, public labeling typically does not name upstream vendors; supplier discovery generally moves to DMF/regulatory systems rather than consumer-facing labeling.
FAQs
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Who is the primary supplier/labeler for BUPHENYL in the US?
Recordati Rare Diseases, Inc.
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What is the active ingredient in BUPHENYL?
Sodium phenylbutyrate.
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Does BUPHENYL labeling always disclose the API manufacturer?
No. Labeling commonly discloses finished-product labeler/manufacturer of record, while API suppliers are often not listed.
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Where should you verify the “manufacturer of record” for procurement?
In the current prescribing information and packaging/label text for the specific market and lot.
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Is BUPHENYL supply organized by regional distributors?
Typically yes. Brand owners usually coordinate distribution, with local distributors handling import and market logistics.
References
[1] Recordati Rare Diseases, Inc. BUPHENYL (sodium phenylbutyrate) prescribing information. (US product labeling).
