Ursodeoxycholic Acid 128-13-2 — China API Manufacturer | USP/EP/JP R&D to Production

China Manufacturing Landscape for Ursodeoxycholic Acid

Ursodeoxycholic Acid (UDCA, CAS 128-13-2) is a naturally occurring bile acid used therapeutically for the dissolution of gallstones, treatment of primary biliary cholangitis (formerly primary biliary cirrhosis), and management of various cholestatic liver diseases. Listed on the WHO Model List of Essential Medicines, UDCA represents one of the highest-volume bile acid APIs produced globally. China dominates world UDCA production, with Chinese manufacturers supplying an estimated 80% or more of the global market. Our production facility is among the leading Chinese producers, exporting pharmaceutical-grade UDCA to finished dosage manufacturers across more than 50 countries.

China’s commanding position in UDCA manufacturing is rooted in two key advantages: abundant access to animal bile (primarily from cattle and poultry) as the natural starting material for chenodeoxycholic acid (CDCA) extraction, and advanced biochemical/chemical conversion technology for the stereoselective epimerization of CDCA to UDCA. These integrated capabilities, refined over decades, provide unmatched production economics and supply security for international pharmaceutical customers.

Manufacturing Process & Facility

Our UDCA manufacturing process begins with extraction of crude bile acids from animal bile through precipitation, saponification, and acidification steps, followed by chromatographic separation to isolate high-purity chenodeoxycholic acid (CDCA). The key transformation—stereoselective epimerization of the 7α-hydroxyl group in CDCA to the 7β-configuration in UDCA—is accomplished through either chemical oxidation-reduction sequence (via 7-keto-lithocholic acid intermediate) or enzymatic biotransformation using immobilized 7α-hydroxysteroid dehydrogenase/7β-hydroxysteroid dehydrogenase enzyme systems.

Final purification involves multiple recrystallization steps from optimized solvent systems to achieve pharmacopeial-grade purity and the required crystal form. The production facility encompasses bile acid extraction workshops, chemical/enzymatic conversion suites, crystallization equipment, and dedicated packaging areas operating under NMPA certification. Annual UDCA production capacity exceeds 300 metric tons, making our facility one of the largest dedicated UDCA manufacturing sites globally.

Quality Standards & Multi-Pharmacopeial Compliance

UDCA API from our facility meets USP, EP, and JP pharmacopeial monograph specifications simultaneously. HPLC purity consistently exceeds 99.0%, with the critical CDCA (7α-epimer) impurity controlled below 0.3% and total related bile acid impurities below 1.0%. Assay by HPLC consistently falls within 98.0-102.0% on the dried basis. Specific optical rotation is verified as a key identity and stereochemical purity indicator for each production batch.

Quality testing encompasses HPLC assay and related bile acid profiling, specific optical rotation, loss on drying, sulfated ash, residual solvents by headspace GC, elemental impurities by ICP-MS, heavy metals, microbial limits testing, and endotoxin testing for injectable-grade material. TSE/BSE risk assessment documentation is provided given the animal-derived starting material origin. ICH Q1A stability studies support a 60-month shelf life when stored under recommended conditions.

Regulatory Documentation

Our UDCA regulatory documentation portfolio is among the most complete in the industry. Active US FDA Type II DMF, EU ASMF, EDQM CEP (Certificate of Suitability to European Pharmacopoeia monographs), and WHO Prequalification documentation are all maintained current. CTD Module 3.2.S packages include full process description, control strategy documentation, impurity qualification with toxicological justification, viral safety evaluation for the animal-derived starting material, and complete stability data. TSE/BSE compliance documentation per EMEA/410/01 Rev.3 is provided as standard. Our regulatory affairs team has extensive experience supporting customer filings worldwide and provides responsive technical support throughout the registration lifecycle.

Packaging & Logistics

UDCA API is packaged in double PE bag-lined fiber drums in standard configurations of 25 kg and 50 kg net weight. Custom packaging for smaller quantities (1 kg, 5 kg) in HDPE containers is available upon request. The product is stable at room temperature and does not require cold chain handling, enabling cost-effective sea freight shipping for bulk commercial orders (typical transit 20-30 days to major destination ports). Air freight is available for urgent or sample shipments with 5-10 business day international delivery. Complete export documentation including CoA, MSDS, phytosanitary certificates, TSE/BSE declarations, and veterinary health certificates (for animal-derived products) is provided. FOB, CIF, CFR, and DDP Incoterms are all supported.

Competitive Pricing & Supply Reliability

As one of the largest-volume UDCA producers globally, our pricing reflects genuine economies of scale and vertical supply chain integration. Multi-ton annual supply agreements benefit from the most competitive pricing available in the market, with guaranteed price stability mechanisms for contracts exceeding 12 months. Standard lead times are 1-2 weeks from maintained stock for quantities up to 5 metric tons, and 3-4 weeks for larger campaign orders. Our strategic raw material procurement program, which includes long-term contracts with bile suppliers across multiple provinces, ensures uninterrupted production capability regardless of seasonal or market fluctuations in raw material availability.

Ursodeoxycholic Acid Specifications