Suppliers and packagers for generic pharmaceutical drug: DEOXYCHOLIC ACID

DEOXYCHOLIC ACID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333	NDA	Kythera Biopharmaceuticals Inc.	61168-101-03	2 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS	2015-06-08
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333	NDA	Kythera Biopharmaceuticals Inc.	61168-101-04	4 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01)	2015-06-08

Deoxycholic Acid Suppliers 2026: Who Supplies Bulk API, Key Intermediates, and Finished-Drug Ingredients

Last updated: May 29, 2026

Deoxycholic acid is supplied as bulk active ingredient (API), commonly via global chemical manufacturers and specialty ingredient firms. For finished drug supply chains, the same supplier universe typically covers analytical reference standards and bulk material used in encapsulated, oral, and injectable dosage forms, subject to GMP and regulatory documentation. Below is the practical supplier map used by buyers for bulk purchasing and regulatory submissions.

Which companies supply deoxycholic acid bulk API?

Major supplier categories:

• Bulk chemical/API manufacturers (chemicals or API-grade deoxycholic acid for pharmaceutical clients)
• Specialty ingredient companies (pharma-grade material, often with documentation packages)
• Regional distributors/agents (source from listed manufacturers and handle logistics, CoA, and compliance)

Top-tier supplier footprint to screen in tenders

Use these as a starting supplier universe for qualification. In practice, buyers shortlist by (1) GMP status for API manufacture, (2) impurity profile reporting, (3) batch traceability and CoA format, (4) DMF/CEP support if relevant, and (5) supply continuity.

• TCI Chemicals (US/EU distribution footprint)
  Strong presence for research and some pharma-grade bulk supply channels; buyers typically qualify via documentation and quality agreements.
• Cayman Chemical
  Known for bile acid reference standards and research-grade offerings; some pharma workflows source through Cayman for standards and method qualification.
• Merck KGaA / MilliporeSigma
  Frequent provider of biochemical standards and pharma-leaning reagents; buyers confirm grade, documentation, and lead times for API-like uses.
• Santa Cruz Biotechnology
  Common for bile acid standards and reagents; qualification depends on target specification grade.
• Santa Cruz / Cayman / Sigma channel suppliers
  Often used for analytical standards and method development rather than commercial API unless GMP documentation is confirmed.

What supplier type fits commercial API procurement?

For commercial-grade supply, the strongest candidates are suppliers that explicitly market:

• GMP manufacturing for API (or manufacturing under an accepted quality system)
• pharmaceutical-grade specifications (USP/EP or internal pharma spec with impurity limits)
• repeatable batch quality and robust change-control reporting

How do deoxycholic acid suppliers differ by grade (USP/EP vs research grade)?

Featured snippet answer: Buyers usually split deoxycholic acid sourcing into “analytical/reference” and “pharma-grade bulk,” with different documentation expectations.

Common grade buckets

• Reference standard grade
  Best for HPLC/LC-MS method validation. Lower emphasis on GMP batch documentation for commercial API use.
• Pharmaceutical grade bulk (API) Requires GMP alignment, tighter impurity controls, and full batch documentation.
• Food/pharma intermediate-grade
  Some suppliers offer “cosmetic or nutraceutical” grade material, which may not map cleanly to FDA/EMA API expectations.

Which distributors stock deoxycholic acid under pharma documentation?

Many “distributors” are resellers or agents. For pharma procurement, they matter less than the underlying manufacturer, but they influence:

• Lead times
• Incoterms and packaging
• CoA format and batch traceability availability
• Regulatory support packages

Buyer screening criteria for distributors/agents

• Evidence of GMP-grade chain of custody
• Willingness to provide full CoA per shipment
• Ability to support audits (or provide audit summaries)
• Consistent spec for impurities and residual solvents
• Change control communications for sourcing shifts

What manufacturing routes affect supplier qualification for deoxycholic acid?

Supplier qualification depends on chemistry control more than branding. Buyers typically assess:

• Starting material availability
• Hydrolysis/oxidation/epimerization control
• Purification method robustness (crystallization, chromatography)
• Impurity strategy (epimers, oxidation products, bile-acid analogs)

Practical route-linked quality risks

• Epimer impurities (stereochemical variants)
• Oxidation-related degradation products
• Residual solvents and process byproducts
• Batch-to-batch polymorphism risk (affecting dissolution and stability in formulations)

What regulatory documentation should you require from deoxycholic acid suppliers?

If sourcing for pharmaceutical development or commercial supply, buyers typically require:

• GMP certificates for API manufacture (or equivalent)
• CoA + specification for incoming material
• Impurity profiles and analytical methods
• DMF/CEP references (when applicable)
• Stability data (for drug substance handling; more relevant for release specs)

Which dosages/products use deoxycholic acid and how does that change supplier selection?

Deoxycholic acid is used in bile-acid related indications and also in formulations where bile acids serve as active ingredient or adjunct. Supplier selection changes depending on whether procurement is:

• API for drug product manufacturing (strict GMP API documentation)
• Finished drug supply (procurement shifts to finished dosage manufacturers and their API sourcing)
• Compounding or clinical supply (often treated as development-grade API with rapid availability)

Which suppliers can support deoxycholic acid reference standards and analytical qualification?

For method development and stability work, buyers often source reference material from:

• Cayman Chemical
• MilliporeSigma (Merck)
• TCI Chemicals
• Santa Cruz Biotechnology

These suppliers reduce timeline risk for analytical work, but commercial-scale API sourcing still requires GMP-grade qualification through the supplier chain.

What is the commercial supplier landscape and how many global sources exist?

The commercial landscape is fragmented:

• Some suppliers focus on standards/research reagents
• Fewer suppliers offer repeatable GMP API bulk with full pharma documentation

In practice, buyers typically maintain:

• A primary GMP-qualified supplier
• A secondary qualified source for continuity
• A standards supplier for analytical method robustness

Key Takeaways

• Deoxycholic acid is sourced from a mix of GMP-capable API manufacturers and reference/reagent suppliers.
• For commercial API use, prioritize suppliers that can provide GMP-grade documentation, full impurity profiles, and consistent specifications.
• Common recognizable suppliers for bile acids and standards include MilliporeSigma, TCI Chemicals, Cayman Chemical, and Santa Cruz, but commercial API qualification requires explicit GMP and pharma-quality readiness.
• Distributor sourcing matters less than confirming the underlying manufacturer and quality documentation chain.

FAQs

1) Who supplies deoxycholic acid for pharmaceutical manufacturing in the US?

Screen for suppliers advertising GMP API manufacturing and provide pharma-grade CoAs, impurity data, and audit support; many recognizable reagent suppliers will still require grade confirmation for API use.

2) What are typical lead times for deoxycholic acid bulk orders?

Lead times vary by grade and GMP status, with standards often faster and GMP pharma-grade API subject to longer qualification and batch scheduling.

3) Can deoxycholic acid be sourced from multiple qualified suppliers?

Yes. Buyers commonly qualify a primary and secondary supplier to reduce supply continuity risk, provided impurity profiles and specifications are aligned.

4) Do deoxycholic acid suppliers provide method development support?

Some suppliers provide analytical methods or typical COA panels for buyers’ characterization, but pharma qualification still requires independent verification in the buyer’s process.

5) How do buyers qualify deoxycholic acid incoming material?

Qualification typically includes receipt of CoA/spec, verification of identity/purity/impurities, checking impurity trends, and confirming suitability for the intended formulation (dissolution and stability work).

References

1. Merck KGaA. MilliporeSigma product listings for deoxycholic acid.
2. TCI Chemicals. Deoxycholic acid product listings and specification pages.
3. Cayman Chemical. Deoxycholic acid product and reference standard listings.
4. Santa Cruz Biotechnology. Deoxycholic acid product listings and specifications.