Last updated: May 26, 2026
Odevixibat supply is concentrated around a small number of contract manufacturing and pharmaceutical supply participants tied to the product’s branded launch and ongoing commercialization. The drug’s supply chain hinges on three layers: (1) active pharmaceutical ingredient (API) manufacture, (2) dosage-form and fill-finish operations for oral solid products, and (3) secondary packaging and distribution. Suppliers vary by geography and pack configuration, and the operating risk for continuity comes from single-site manufacturing in oral-solid fill and from any API bottleneck.
Which companies supply odevixibat (Ocaliva) in the US?
Odevixibat’s commercial US supply is tied to the marketing authorization holder and its listed manufacturing and distribution participants on FDA regulatory submissions and on the product labeling. In practice, US “suppliers” break into:
- API manufacturers (process and intermediates)
- Finished dose manufacturers (tablet and/or capsule manufacturing, if applicable to the product form)
- Packager-distributors (bottling, blisters, unit cartons, case packs)
- Labelers and logistics distributors
Odevixibat is marketed under the brand name Ocaliva. The product’s controlled supply is typically centralized under the product owner’s approved manufacturing network. Publicly indexed supplier rosters for odevixibat should be pulled from:
- FDA product labeling (Highlights of Prescribing Information, section “How Supplied/Storage and Handling”)
- FDA appointment letters and manufacturing change supplements (prior approval and CBE variations)
- Orange Book records tied to the NDA and listed drug
Practical supplier mapping for diligence
- Start with the NDA holder’s listed manufacturing sites (finished dosage and packaging) for Ocaliva.
- Cross-check the manufacturing site identifiers with establishment registration numbers in FDA’s registration and listing system.
- Confirm whether API is manufactured by the same site group or by a dedicated API vendor, then track intermediates for risk exposure.
Who makes the odevixibat active pharmaceutical ingredient (API)?
API sourcing is usually done through one or more specialized chemical manufacturers under GMP contracts. For odevixibat, API supply should be evaluated by three diligence lenses:
- Route dependency: steps/intermediates that are unique to odevixibat
- Site dependency: whether API is made at one site or multiple qualified sites
- Change history: whether the API manufacturer has issued recent manufacturing process change submissions
What to verify in records
- GMP manufacturing site names tied to odevixibat API in FDA approvals and supplements
- Whether there is a named “manufacturer” vs “responsible for release” distinction
- Whether the API site has had warning letters, import alerts, or repeated 483 observations
Which contract manufacturers produce odevixibat tablets/capsules (finished dose)?
Finished dose suppliers for oral solid products typically include:
- Tablet or capsule manufacturing plants
- Hold-time and in-process testing labs
- Fill-finish or blister/packaging lines
- Warehousing and distribution logistics
For odevixibat, the finished-dose suppliers are those listed in the FDA-approved labeling for Ocaliva and in manufacturing supplement records tied to the NDA. Supply continuity risk often comes from the packaging step for oral solids, since blistering, bottle filling, and serialization lines can be single-site.
What to check
- Site counts per dosage form (and per strength)
- Whether packaging lines share the same production area and whether they can reconfigure quickly
- Lead times for excipients and any controlled release components (if used)
Where is odevixibat packaged and distributed?
Secondary packaging and distribution suppliers are listed on product labeling and on distribution authorization elements. In US commercialization, the packager-distributor may be different from the finished-dose manufacturer.
For diligence, map:
- Packaging supplier per strength and pack type
- Serialization and labeling vendor
- Distributor of record (often a national or regional logistics entity)
Supply risk checkpoints
- Serialization line capacity
- Regional distribution warehouse dependency
- Port of entry and customs clearance partners for international sourcing
What are the Orange Book listings for Ocaliva and what do they imply for supplier continuity?
Orange Book listing(s) tie the NDA to listed patents and (for generics) to whether alternative manufacturers can use design space or formulation workarounds. For odevixibat, supplier continuity is independent of Orange Book exclusivity, but litigation and generic planning can change manufacturing behavior. If a company is preparing a generic or 505(b)(2), it may secure parallel manufacturing capacity or qualify additional sites.
Key diligence implication
- When patents near expiration, finished-dose and packaging suppliers often qualify backup plants to reduce launch risk, which can change supplier availability and pricing.
How does supply chain risk show up for odevixibat (oral solid manufacturing barriers)?
Even when multiple manufacturers exist on paper, the practical bottlenecks are:
- API intermediate availability for odevixibat’s synthesis
- Granulation/spray-drying or coating steps tied to the drug’s specific formulation characteristics (if relevant to the dose form)
- Blend uniformity controls and potency testing capacity
- Packaging line downtime risk (blister/bottle filling)
Common failure modes
- Single qualified blister line for one NDC strength
- Limited vendor capacity for critical excipients
- API batch rejection leading to short-term supply constraints
Which suppliers are likely to be used for international odevixibat supply?
International supply networks typically use:
- Local packager-distributors under the marketing authorization holder
- Contract manufacturers for finished dose in the approved region (or import into the region)
For global diligence, evaluate:
- Whether the region licenses local packaging only or also local manufacturing
- Whether regulatory submissions name the same GMP site identifiers across regions
- Whether supply interruptions in one region force cross-border import
What supplier contracts matter most for continuity of supply (API, finished dose, packaging)?
The contract structure that most affects continuity is usually split across:
- Long-term API supply agreements (with multi-year pricing and volume commitments)
- Finished dose manufacturing with defined release site responsibilities
- Packaging and labeling contracts with serialization compliance obligations
Commercial lever
- A supplier with strong change-control maturity (QMS, tech transfer readiness, and validation documentation) reduces requalification risk if a backup site is used.
Key Takeaways
- Odevixibat (Ocaliva) supply is concentrated in a tightly controlled GMP manufacturing network covering API, finished dose, and packaging/distribution.
- The operational definition of “suppliers” for due diligence is the set of FDA-listed manufacturing and packaging sites tied to Ocaliva’s approved product labeling and NDA supplements.
- The highest continuity risk typically comes from single-site packaging capacity and any API intermediate bottleneck.
- Supplier mapping should be done from FDA labeling and approval history records tied to the odevixibat NDA, then validated against GMP establishment registrations.
FAQs
1) Who is the marketing authorization holder for odevixibat (Ocaliva) and how does that affect supplier identification?
The product owner controls the approved manufacturing network and is the anchor for mapping FDA-listed manufacturing and packaging sites to real suppliers.
2) What documents show odevixibat manufacturing sites?
FDA-approved labeling and manufacturing supplement records tied to the odevixibat NDA show the named manufacturing, packaging, and release sites.
3) Are there multiple API suppliers for odevixibat?
API supply often has one primary site plus secondary qualified options, but the definitive answer comes from NDA approval history and site-level listings.
4) Can packaging suppliers differ by strength or NDC?
Yes. Oral-solid products often have separate packaging line qualification per strength and pack format, so NDC-level mapping is important.
5) What changes are most likely to disrupt odevixibat supply?
API process changes, packaging line downtimes, and excipient vendor disruptions, especially if only one qualified site exists for a critical step.
References (APA)
- U.S. Food and Drug Administration. Ocaliva (odevixibat) prescribing information and related FDA labeling records. (FDA Product Labeling).
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA Orange Book).
- U.S. Food and Drug Administration. Drug Establishments Current Registration Site Data. (FDA Establishment Registration and Listing).
