Advanced biochemical inputs engineered to meet the stringent pharmaceutical standards of the Kansai biomedical region.
Osaka has historically served as the epicenter of Japan’s pharmaceutical innovations. From the traditional medicine merchants of Doshomachi to the modern biotechnology hubs in the Kansai Science City, Osaka hosts pioneering multinational companies and research centers. The demand for highly pure, reliable APIs—particularly Cholic Acid series products—is accelerating. Bile acids are no longer viewed merely as digestive surfactants; they are now recognized as critical ligands for nuclear receptors (such as FXR and TGR5), essential components in lipid nanoparticle (LNP) drug delivery systems, and key ingredients in advanced diagnostic reagents.
In Osaka's research institutions, primary and secondary bile acids like Chenodeoxycholic Acid (CDCA) and Ursodeoxycholic Acid (UDCA) serve as essential scaffolds for therapeutic molecules targeting non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and various metabolic syndromes. Achieving high purity, low endotoxin levels, and batch-to-batch consistency is critical to meeting Japan's strict PMDA (Pharmaceuticals and Medical Devices Agency) regulatory standards. Our cholic acid series meets these challenges directly, providing Osaka's laboratories and production facilities with reliable chemical inputs.
The global market for Cholic Acid and its derived salts is expanding due to advances in biotechnology and drug delivery systems. Globally, the pharmaceutical sector remains the largest consumer, driven by the synthesis of Ursodeoxycholic Acid (UDCA) and Tauroursodeoxycholic Acid (TUDCA). These compounds protect neurons and liver tissue, making them key candidates for treating neurodegenerative diseases and cholestatic liver disorders.
Additionally, the transition from traditional extraction methods (derived from bovine or porcine bile) to highly controlled, sustainable, and bio-based synthetic biology pathways is reshaping the global supply chain. Concerns over Bovine Spongiform Encephalopathy (BSE) and other zoonotic pathogens have driven global procurement managers to prioritize raw materials with complete traceability and verified safety profiles. Modern facilities must adhere to strict quality management systems to guarantee that natural extraction processes are clean, sustainable, and free from contaminants.
Chengdu Chenlv Herb Co., Ltd. uses China's raw material access and advanced processing infrastructure to supply high-purity bile acid derivatives. Our production facilities, located in Sichuan, benefit from direct access to raw materials and a highly integrated chemical processing network. This geographic advantage helps us maintain a stable supply chain, mitigating the raw material shortages that often affect European and North American manufacturers.
Our production efficiency is supported by automated extraction technologies, closed-loop solvent recovery systems, and advanced crystallization processes. By optimizing crystallization yields and using high-throughput HPLC purification, we can offer competitive pricing without compromising quality. Chengdu Chenlv Herb's facilities operate under strict ISO, Kosher, and Halal certifications, ensuring that every batch shipped to Japan meets or exceeds international pharmacopeia standards (USP, EP, JP).
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Leveraging high-purity natural extracts for diverse industrial sectors
Chenlv Herb provides one-stop contract manufacturing services
Our company is certified by ISO9001, ISO22000, HALAL, KOSHER and FDA, among others.
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Essential guidance for procurement managers, formulation scientists, and QA directors.
We implement a strict origin-tracing protocol for all bovine and porcine crude bile inputs. Each batch undergoes chemical sterilization, purification, and multi-stage crystallization. This process eliminates lipid residues and denaturation elements, ensuring compliance with global TSE/BSE-free standards.
Cholic acid is a primary bile acid with three hydroxyl groups (3α, 7α, 12α). Chenodeoxycholic acid (CDCA) lacks the 12α-hydroxyl group and acts as a potent FXR agonist. Deoxycholic acid is a secondary bile acid with hydroxyls at 3α and 12α, often used in cell lysis and aesthetic fat-dissolving formulations.
Our UDCA features a purity profile of ≥99.0% by HPLC. We control impurity levels, ensuring single impurities stay below 0.1% and total impurities remain under 0.5%, in accordance with EP and USP requirements.
We provide full documentation for Japan's PMDA import clearances, including DMF numbers, Certificates of Analysis (COA) with method validation, BSE/TSE declaration statements, and comprehensive Allergen sheets.
Yes. Our micronization facility can process dry crystals to meet specific requirements (e.g., D90 < 10 microns), helping to optimize dissolution rates in aqueous tablet formulations.
Using our partner logistics network, air cargo shipments to Kansai International Airport (KIX) typically arrive in 3-5 working days. Ocean freight shipments to the Port of Osaka generally take 12-15 days.
Complete selection of bile-derived APIs and biochemical reagents for research, clinical, and industrial manufacturing.
Optimize your project timelines with our supply chain solutions, high-purity bile acid derivatives, and comprehensive regulatory documentation.
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