Last updated: May 30, 2026
RAVICTI (glycerol phenylbutyrate) suppliers: manufacturers, contract manufacturing, and API sources
RAVICTI (glycerol phenylbutyrate, “GPB”) is supplied in the US by Horizon Pharma and its affiliates through United States distribution channels controlled by its marketing authorization holder(s). The product’s supply chain depends on GPB active pharmaceutical ingredient (API) manufacturing and finished-dose production (liquid formulation) under contract or internal GMP sites. No complete, auditable supplier list (API makers, contract packagers, and finished-dose CMO names) can be produced from the available information provided in this request.
Who are the API and finished-dose manufacturers (CMO) for RAVICTI?
A complete supplier map requires linking:
- the RAVICTI NDA holder/labeler to
- the site-specific GMP manufacturing data (FDA facility registrations, drug product labeler/manufacturer fields, and inspection history) and
- the Orange Book / FDA application manufacturing disclosures that specify who makes the API and who fills/finishes the drug product.
This request contains no such facility, labeler, or application-level details, so a verified “API supplier + CMO supplier” roster cannot be listed without risking factual errors.
What roles exist in RAVICTI’s supply chain?
- API manufacturer (GPB synthesis and purification)
- Drug product manufacturer (liquid formulation, blending, fill-finish, packaging)
- Distributor/labeler (US market authorization and shipment channels)
What is the Orange Book labeler/manufacturer information for RAVICTI?
Orange Book listings typically help identify:
- NDA number
- proprietary name and active ingredient
- application and patent/exclusivity linkages
However, supplier identity is not reliably derivable from patent listings alone, and this request does not include:
- the Orange Book record
- labeler name(s)
- the manufacturer fields
A supplier list cannot be produced from absent Orange Book data.
What FDA manufacturing facilities are registered for RAVICTI (drug product and API)?
FDA facility registration and drug establishment data can identify:
- registered manufacturing sites
- roles (API, drug product, repackaging, etc.)
- business names tied to facility addresses
This request includes no facility identifiers, addresses, or FDA establishment numbers, so no definitive supplier names can be enumerated.
How many companies supply RAVICTI in the US market?
Without:
- FDA establishment datasets,
- current labeler/manufacturer fields from product labeling, and
- verified distributor/wholesaler sourcing data,
a “number of suppliers” would be speculative.
Which companies are likely contract manufacturers of glycerol phenylbutyrate?
The likely set could include global chemical and pharmaceutical manufacturing groups, but selecting names requires actual linkage to:
- FDA-registered facilities for GPB API and/or RAVICTI finished product,
- NDA/CMC disclosures, or
- inspection outcomes tied to specific site names.
No such linkage data is present in the request.
What distributors and wholesalers supply RAVICTI to US hospitals and pharmacies?
Distributor coverage is determined by:
- labeler distribution agreements,
- wholesaler network coverage,
- site-of-distribution logistics.
A factual list of distributors cannot be generated without the labeler and distribution channel data.
What supply risks exist for RAVICTI (API concentration, single-site fill-finish, or seasonal constraints)?
Supply risk assessment depends on:
- number of qualified GMP sites,
- whether API and drug product are made at the same or different sites,
- historical inspection and supply disruption records,
- documented regulatory actions.
This request provides no supply-chain structure.
Key takeaways
- RAVICTI supplier identification requires FDA facility registrations and labeling/CMC manufacturing disclosures.
- The request provides no NDA/labeler fields, FDA establishment identifiers, or facility site data.
- A verified supplier list (API makers and finished-dose CMOs) cannot be produced from the information provided.
FAQs
- What company holds the RAVICTI US NDA/labeler position?
- Which FDA-registered facilities manufacture RAVICTI drug product?
- Who manufactures glycerol phenylbutyrate (GPB) API for RAVICTI?
- How can I find RAVICTI contract manufacturing sites from FDA data?
- What evidence supports a given supplier’s role in RAVICTI manufacturing (inspection reports, labeling, registration)?
References
- No sources were provided in the request.
