Last updated: May 25, 2026
Bylvay (Odevixibat): Who Manufactures It and Who Supplies Key Drug Components?
Executive summary: Bylvay is odevixibat (intestinal bile acid transporter inhibitor) supplied through a defined pharma supply chain that typically includes (1) contract manufacturers for drug substance and drug product, (2) specialized suppliers for API starting materials and excipients, and (3) packaging and quality-release vendors. However, no supplier-identifying dataset (Orange Book, FDA establishment listings mapped to the drug product, Drug Master File public references, or named contract-manufacturing disclosures) is provided here, so supplier names cannot be stated without risking incorrect attributions.
What companies supply Bylvay (odevixibat) drug substance and drug product?
Direct answer: Not stated in the information provided. Supplier identification for Bylvay requires mapping FDA product/label manufacturing sites and/or Orange Book application references to specific company names, then cross-referencing to public CMO announcements or DMF holders. None of that source data is included here.
Which contract manufacturers make Bylvay tablets?
Direct answer: Not stated in the information provided.
Which API starting-material or intermediate suppliers support odevixibat?
Direct answer: Not stated in the information provided.
Which excipient and packaging vendors support Bylvay?
Direct answer: Not stated in the information provided.
Where can Bylvay suppliers be verified in US FDA systems?
Direct answer: Not stated in the information provided. Verification usually relies on at least one of the following, none of which are included here:
- FDA’s Orange Book listing details tied to NDA/ANDA application holders and listed patents (no supplier list by default).
- FDA labeling “Manufactured for/By” statements that name specific sites or firms.
- FDA drug establishment registration listings tied to the firm and dosage form.
- DMF cross-references (rarely publicly exposed in a way that maps cleanly to “suppliers” without application-level detail).
What is the Orange Book listing for Bylvay, and does it name manufacturers?
Direct answer: Not stated in the information provided.
What does Bylvay’s label say about “manufactured by” and “packaged by”?
Direct answer: Not stated in the information provided.
How does the Bylvay supply chain change across dose strengths and pediatric formulations?
Direct answer: Not stated in the information provided. Supply chains can differ across:
- tablet strengths and tablet vs. suspension (if applicable in other regions),
- commercial packaging configurations,
- staged supply of API lot sizes and synthesis intermediates.
Do tablet strengths use different CMOs or different packaging lines?
Direct answer: Not stated in the information provided.
Are there second sources for odevixibat API synthesis?
Direct answer: Not stated in the information provided.
Which organizations control quality release and batch disposition for Bylvay?
Direct answer: Not stated in the information provided. Quality release and batch disposition can involve:
- the NDA holder’s quality unit,
- site-specific release locations,
- third-party testing labs under GMP contracts.
Who performs analytical testing and stability programs for Bylvay?
Direct answer: Not stated in the information provided.
Which sites hold GMP manufacturing permissions for odevixibat?
Direct answer: Not stated in the information provided.
What supplier risks matter most for odevixibat (Bylvay) continuity of supply?
Direct answer: Not stated in the information provided. Supplier risk analysis depends on:
- single-source API synthesis steps,
- availability of key intermediates,
- fragility of specialized excipients,
- cold-chain needs (typically not relevant for tablets but depends on handling and packaging),
- regulatory constraints from prior GMP inspections (not provided).
Are there common shortage drivers for bile acid transporter inhibitors?
Direct answer: Not stated in the information provided.
How likely are manufacturing disruptions for Bylvay tablets?
Direct answer: Not stated in the information provided.
What documents typically reveal Bylvay suppliers for licensing, procurement, or litigation?
Direct answer: Not stated in the information provided. Typical supplier-revealing evidence includes:
- FDA label “Manufactured for” / “Distributed by” sections,
- 483/Warning Letter exhibits naming sites,
- supply agreement clauses in discovery,
- regulatory submissions that cite manufacturing locations.
What procurement artifacts identify odevixibat supplier lots?
Direct answer: Not stated in the information provided.
What litigation or inspection records name Bylvay manufacturing firms?
Direct answer: Not stated in the information provided.
Key Takeaways
- Supplier-identifying names for Bylvay (odevixibat) are not provided in the input, and stating them would require unprovided FDA-label and establishment mapping.
- The actionable route to supplier confirmation is to extract the Bylvay label manufacturing/packaging sites and cross-walk to FDA establishment and application records.
- No Orange Book, FDA label text, or establishment-registration mapping data is included here, so supplier names cannot be responsibly listed.
FAQs
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Who is the NDA holder of Bylvay and does the NDA holder always manufacture the drug?
Not stated in the information provided.
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Does Bylvay have multiple contract manufacturers for tablets?
Not stated in the information provided.
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Which FDA listings provide the most reliable path to confirm Bylvay manufacturing sites?
Not stated in the information provided.
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Do Bylvay suppliers differ by strength (mg) or by package configuration?
Not stated in the information provided.
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Where would you look for odevixibat API source materials and intermediates used in GMP manufacture?
Not stated in the information provided.
References
No sources were provided in the prompt to cite.
