Home / PharmaZell / Bile Acids
Bile acid APIs and derivatives
We are a global leader in high-purity bile acid APIs and derivatives, offering sustainable enzyme-based manufacturing, global regulatory strength, and secure, vertically integrated supply.
Global supply and manufacturing excellence
PharmaZell is a trusted global manufacturer of high-purity bile acid APIs and derivatives. Our extensive product portfolio includes Ursodeoxycholic Acid (UDCA), Chenodeoxycholic Acid (CDCA), Cholic Acid, and a growing range of bile acid derivatives. With decades of experience and sustainable enzyme-based production, we deliver reliable partnerships backed by regulatory excellence, technical depth, and a fully traceable, vertically integrated supply chain.
| Active Ingredient | CAS Number | Therapeutic areas | Monograph | Available grades | Regulatory Documentation | Produced in |
|---|---|---|---|---|---|---|
| Ursodeoxycholic Acid Ursodiol UDCA | 128-13-2-SP | Gallstone Dissolution, Primary Biliary Cholangitis | EP, IP, JP, USP | Micronized Milled Standard |
BR DMF** CEP (DUAL) EU DMF IN REG. CERTIFICATE JP DMF** KR DMF** US DMF# |
GRO, VIZ |
| Cholic Acid | 81-25-4-SP | Building Block for Bile Acid Derivatives | INTERMEDIATE | Standard | CEP (BSE/TSE) | VIZ |
| Sodium Deoxycholate | 302-95-4-SPD | Culture Media & Diagnostics | EXCIPIENT | Standard | CEP (BSE/TSE)** | VIZ |
| Glycocholic acid | 475-31-0-SPD | EXCIPIENT | EXCIPIENT | Standard | CEP (BSE/TSE) | VIZ |
Vertically integrated for reliability
Our bile acid supply chain is fully vertically integrated and bovine-derived, managed through our Pharmachol subsidiaries. We collect raw bile from audited partner slaughterhouses across the USA, Brazil, India, Australia, and South Africa — ensuring complete control, traceability, and risk diversification. This structure guarantees robust supply continuity and compliance for rare disease APIs and other tightly regulated markets.
Pharmaceutical-grade APIs for regulated markets
We apply proprietary green enzyme technology to manufacture bile acid APIs at globally approved sites (EMA, US FDA, CDSCO, PMDA, ANVISA, KFDA). Our processes minimize solvent use and chemical inputs, delivering sustainable, compliant products that meet EP, USP, and JP standards. We supply UDCA, CDCA, and Cholic Acid in multiple formats, with full regulatory documentation (CEP, DMF, JDMF).
Expanding portfolio of bile acid derivatives
PharmaZell continues to expand its bile acid derivative range for pharmaceutical and diagnostic use. Products include Sodium Cholate (non-GMP grade), Deoxycholic Acid, Sodium Deoxycholate, Bile Salts No. 3, and Glycocholic Acid. Custom specifications and GMP-grade options are available, supporting innovation across rare diseases, niche therapies, and early-stage R&D.
Why partner with us?
Fully traceable, vertically integrated sourcing
Enzyme-based, sustainable manufacturing
Global compliance with major agencies (FDA, EMA, PMDA, etc.)
Custom particle sizes and specifications available
Partner with us today
From global commercial supply to rare disease development, PharmaZell is your partner for reliable, sustainable bile acid APIs.