Last updated: April 23, 2026
Who Supplies Ursodiol for Pharmaceutical Manufacturing?
Ursodiol (ursodeoxycholic acid; UDCA) is supplied to the pharmaceutical supply chain primarily in two forms: (1) API-grade ursodiol (bulk active pharmaceutical ingredient) and (2) intermediates/starting materials and chemical precursors used to manufacture UDCA. The commercial landscape is split between API manufacturers and contract manufacturers that handle crystallization, milling, packaging, and regulatory batch production for branded and generic products.
What types of suppliers exist in the ursodiol value chain?
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API manufacturers (UDCA synthesis and purification)
Produce API-grade ursodiol that is sold to branded/generic formulators and CDMOs.
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Regulatory-grade finishers (crystallization, micronization, packaging)
Handle conversion of bulk API into marketable forms (particle size control, packaging, labeling) under GMP.
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Intermediates and raw-material suppliers (chemical precursors)
Provide bile-acid related precursors and processing inputs used upstream in UDCA manufacture.
Which companies supply ursodiol API or related manufacturing supply?
Ursodiol sourcing is dominated by Asia-based and global chemical/pharma ingredient manufacturers, with multiple firms appearing across public regulatory listings for UDCA products and API supply. The most consistently identified supplier set includes the following companies.
API suppliers and distributors (global)
| Company |
Supplier role in ursodiol supply chain |
Common supply pathway |
| Hangzhou Pingchuang Pharmaceutical Co., Ltd. |
UDCA/API supplier |
Bulk API sales into generic and brand supply chains |
| Hunan Erkang Pharmaceutical Co., Ltd. |
UDCA/API supplier |
API supply into contract manufacturing and distributors |
| Hebei Huarui Pharmaceutical Co., Ltd. |
UDCA/API supplier |
API ingredient supply for solid oral generics |
| Shaanxi Huike Biological Technology Co., Ltd. |
UDCA/API supplier |
API ingredient supply for pharma manufacturers |
| Zhejiang Garden Biotech Co., Ltd. |
UDCA and bile-acid ingredient supplier |
Ingredient supply and formulation support for pharma |
| Shandong Freda Pharmaceutical Co., Ltd. |
UDCA/API supplier |
API supply and GMP batch availability for generics |
Specialty and bile-acid focused manufacturers
| Company |
Supplier role |
Typical offering |
| Keaixin Bio-Chemical Co., Ltd. |
Bile-acid related ingredient supplier |
UDCA-focused ingredient batches for pharma use |
| Liaoning Wangyuan Pharmaceutical Co., Ltd. |
API ingredient supplier |
Ursodiol API bulk |
| Zhejiang Hisun Pharmaceutical Co., Ltd. |
Large-scale ingredient/pharma supplier |
Ingredient supply chain presence for bile-acid derivatives |
How do suppliers deliver ursodiol to drug manufacturers?
Typical commercial delivery and batch handling
Ursodiol API is generally provided as bulk API in GMP packaging (drums or bags) with documentation aligned to regulatory requirements, then finished by tablet/capsule manufacturers or CDMOs.
Common downstream processing:
- Crystallization and purification control (particle properties can affect dissolution and stability)
- Milling/micronization when required by product specification
- Packaging under GMP and provision of CoA, impurity profiles, and stability data packages
Regulatory documentation commonly required by customers
- Certificate of Analysis (CoA) for each batch
- Impurity specifications and analytical methods summary
- Stability summary (where required by the dossier)
Where can buyers verify ursodiol supplier status?
Drug regulatory and listing sources
The two most practical ways to validate supplier identity and linkage to marketed products are:
- FDA Orange Book listings (for finished products) to identify listed NDA/ANDA holders and infer the supply chain ecosystem for UDCA products.
- Drug Master Files (DMFs) and API listing ecosystems used for referencing API sources in generic submissions.
Because supplier identification can be product-dependent (a given API supplier may support multiple finished-product dossiers), buyers typically triangulate using:
- Finished-product manufacturers’ supplier qualification packages (from RFP disclosures or procurement systems)
- Regulatory dossier linkages (DMF references and API manufacturing site listings)
- Market intelligence from distributors and ingredient catalogs
What should procurement teams ask suppliers for ursodiol?
Minimum qualification package for API procurement
Procurement should require:
- GMP manufacturing status and latest inspection/schedule summaries (where available through audits)
- Impurity profile and specification alignment to the target monograph (commonly USP/EP-style requirements)
- CoA format, data fields, and release testing suite
- Stability protocol and retest period justification
Quality risk points tied to ursodiol
- Particle size/dissolution behavior (especially for direct-to-market generic formulations)
- Hydroxylation and bile-acid impurity suite (process dependent)
- Lot-to-lot consistency across crystallization and purification routes
Key Takeaways
- Ursodiol supply is structured around API manufacturers, GMP finishers, and upstream bile-acid precursor suppliers.
- Supplier lists in the UDCA market repeatedly surface multiple Asian API manufacturers and bile-acid ingredient specialists that provide bulk API into global generic and branded finished-product supply chains.
- Procurement should validate sourcing through regulatory dossier linkages and enforce API specification, impurity profile, and lot release documentation as hard requirements.
FAQs
Who typically supplies ursodiol API?
API suppliers for ursodiol are usually chemical/pharma ingredient manufacturers that provide bulk UDCA under GMP, with some firms also supporting finishing steps like crystallization or packaging.
Is ursodiol sourced from a single global supplier?
No. Ursodiol API supply is distributed across multiple manufacturers, and finished-product supply relies on qualified alternate sources for continuity and cost control.
Do ursodiol suppliers also provide intermediates?
Many upstream bile-acid and chemical suppliers provide intermediate materials or process inputs used to manufacture UDCA.
How do drug manufacturers validate an API supplier for ursodiol?
They use qualification audits, spec/CoA package review, and regulatory dossier linkage evidence (such as API references in submissions), then lock a supplier through quality agreements.
What documentation matters most when buying ursodiol API?
Batch CoA, impurity specifications and profiles, GMP status, analytical method documentation, and stability/retest period support.
Sources (APA)
[1] FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (n.d.). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
[2] European Medicines Agency. (n.d.). Public information on medicinal products and manufacturing/authorization context. https://www.ema.europa.eu/
[3] WHO. (n.d.). Quality assurance and GMP-related guidance references for APIs (general framework). https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/quality-assurance
[4] Manufacturer and supplier listings for ursodiol/UDCA in pharmaceutical ingredient catalogs and business registries (company profile pages). (n.d.). Examples include supplier profile pages for Hangzhou Pingchuang Pharmaceutical Co., Ltd., Hunan Erkang Pharmaceutical Co., Ltd., Hebei Huarui Pharmaceutical Co., Ltd., Shaanxi Huike Biological Technology Co., Ltd., Zhejiang Garden Biotech Co., Ltd., Shandong Freda Pharmaceutical Co., Ltd., Keaixin Bio-Chemical Co., Ltd., and Liaoning Wangyuan Pharmaceutical Co., Ltd.
