Suppliers and packagers for generic pharmaceutical drug: CHENODIOL

CHENODIOL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lgm Pharma	CHENODIOL	chenodiol	TABLET;ORAL	091019	ANDA	Travere Therapeutics	68974-876-40	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68974-876-40)	2015-12-28
Mirum	CTEXLI	chenodiol	TABLET;ORAL	219488	NDA	Mirum Pharmaceuticals Inc.	79378-310-90	100 TABLET, FILM COATED in 1 BOTTLE (79378-310-90)	2025-04-04

Suppliers and packagers for generic pharmaceutical drug: CHENODIOL

Last updated: May 24, 2026

CHENODIOL Suppliers List (Manufacturers, API Sources, Private-Label Options)

Chenodiol (chenodeoxycholic acid, CDCA) supply is dominated by specialty ingredient manufacturers and contract pharmaceutical supply chains that handle bile acid API and finished-dose distribution. It is typically sourced either as chenodeoxycholic acid API or as finished chenodiol tablets/capsules sold into institutional and specialty pharmacy channels, depending on country-specific approvals.

Who supplies chenodiol (chenodeoxycholic acid) to pharmacies and wholesalers?

Chenodiol supply is handled through two primary procurement routes:

• API route: Contract manufacturers and specialty distributors buy chenodeoxycholic acid (CDCA) as API, then formulate and package finished product under local marketing authorizations (or under contract packaging arrangements).
• Finished-dose route: Wholesalers procure finished chenodiol through national marketing authorization holders and parallel distributors, especially where local formulation capacity is limited.

Procurement reality: CDCA is not a high-volume primary-care drug. Supply reliability tends to track specialty chemical production and region-specific finished product availability.

What supplier types exist for chenodiol?

1. API producers (bile acid / steroidal acid specialty chemical manufacturers)
2. Finished-dose marketers (regional MA holders)
3. Contract manufacturers (CMC and packaging for tablets/capsules)
4. Specialty wholesalers (institutional distribution and hospital pharmacies)

How do you identify the right chenodiol supplier for sourcing?

Use the following supplier documentation fields when mapping vendor eligibility:

• GMP manufacturing site(s) for API or finished dosage form
• DMF status for API (where applicable in the target jurisdiction)
• CoA and batch traceability cadence
• Stability package coverage for intended shelf-life and storage conditions
• Regulatory status aligned with the target market’s approved drug submission

What manufacturers make chenodeoxycholic acid (CDCA) API?

Chenodeoxycholic acid API is produced by specialty chemical and pharmaceutical-grade bile acid manufacturers. In practice, sellers for chenodiol supply chains include:

• Bile acid API manufacturers supplying CDCA to pharma formulation houses
• Distributors that act as regional importers of API or finished chenodiol

Key business point: many “chenodiol suppliers” list API supply, but only some can support commercial finished-dose needs (tablet/capsule packaging, local labeling, regulatory dossier alignment).

Which supplier documents matter for API vendor qualification?

• GMP certificate for the CDCA site (API and, if offered, drug product)
• Impurity profile specifications (bile acid isomers and oxidation-related impurities are typical control points)
• Analytical methods alignment with pharmacopeia (USP/EP/JP where required)
• Risk controls for cross-contamination, especially for steroid-related intermediates

Which companies distribute finished chenodiol tablets/capsules?

Finished chenodiol distribution is usually managed by:

• Regional MA holders (drug product authorization holders)
• Wholesalers and specialty distributors authorized for controlled cold chain is not typically required, but handling and storage conditions still matter for bile acids
• Parallel trade operators where permitted by local law

Supplier selection criteria that drive successful procurement:

• Guaranteed availability windows (lead times and safety stock)
• Batch-to-batch consistency and stability compliance
• Ability to provide regulatory and traceability packs (CoA, CoC, import documents)

Is chenodiol API the same as chenodeoxycholic acid for sourcing?

Yes in substance, but not in regulatory and commercial terms.

• Chemically, chenodiol = chenodeoxycholic acid (CDCA).
• Commercially, supply differs by whether vendors provide:
  • API (used for local formulation by licensed manufacturers), or
  • Finished drug product (tablet/capsule with local labeling, packaging, and regulatory submission).

How does supplier availability vary by country?

Availability for chenodeoxycholic acid and chenodiol finished product depends on:

• whether a local marketing authorization exists for chenodiol in that country,
• whether regional wholesalers hold inventory,
• whether API supply is sourced through one or two qualified CDCA producers.

Commercial implication: procurement lead times can expand quickly if the local distributor relies on a single importer or a single API producer batch stream.

What are the key risks when sourcing chenodiol from suppliers?

1. Regulatory mismatch risk
   • Ordering API when the intended use requires finished-dose regulatory status.
2. Quality drift risk
   • Variation in impurity profile across vendors or sites.
3. Supply interruption risk
   • CDCA production often runs on specialty schedules.
4. Documentation risk
   • Missing batch traceability, inadequate CoA depth, or incomplete stability data for finished-dose use.

Key Takeaways

• Chenodiol supply typically comes either through CDCA API producers or regional finished-dose marketing/distribution channels.
• Vendor qualification should prioritize GMP coverage, DMF readiness (where applicable), impurity specifications, CoA depth, batch traceability, and stability alignment.
• Country-specific marketing authorization and wholesaler network strongly affect availability and lead times.

FAQs

1. What documentation should I require from a chenodeoxycholic acid (CDCA) API supplier?
2. How can I tell whether a “chenodiol supplier” is offering API versus finished tablets?
3. What lead times are typical for specialty bile acid API like CDCA?
4. What quality specifications matter most for chenodiol/bile acid impurities?
5. What procurement strategy reduces stockout risk for chenodiol in smaller markets?

References

1. USP Dictionary of Medical Terms. (n.d.). Chenodeoxycholic acid. U.S. Pharmacopeia.
2. European Pharmacopoeia. (n.d.). Chenodeoxycholic acid monograph. European Directorate for the Quality of Medicines.