High-Quality UDCA Medication Manufacturers & Companies

Leading the Global Biopharmaceutical Supply Chain with Certified Ursodeoxycholic Acid APIs and High-Purity Plant-Derived Extract Solutions

Deep-Dive: The Role of UDCA (Ursodeoxycholic Acid) in Modern Pharmacotherapy

Ursodeoxycholic Acid (UDCA), a naturally occurring secondary bile acid, has evolved into a cornerstone therapeutic agent for hepatology and gastroenterology. Originally discovered in bear bile, modern biotechnology and pharmaceutical chemistry allow manufacturers to produce UDCA through chemical synthesis and enzymatic conversion from primary bile acids, eliminating dependency on animal products. This shift ensures consistent quality, strict impurity control, and scaling capabilities that comply with international standards.

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Primary Biliary Cholangitis (PBC)

UDCA acts as a hydrophilic bile acid, displacing toxic hydrophobic bile acids from the hepatic pool. This action stabilizes hepatocyte membranes and reduces micro-inflammation, slowing the progression of hepatic fibrosis in PBC patients.

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Gallstone Dissolution

For patients with cholesterol gallstones who are ineligible for surgery, oral UDCA decreases biliary cholesterol saturation. This allows cholesterol to gradually disperse from the stones into the bile phase, facilitating dissolution.

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FXR & Neuroprotection

Recent research highlights UDCA's role in modulating the Farnesoid X Receptor (FXR) and cytoprotective properties. Emerging clinical trials explore its potential in neurodegenerative conditions, metabolic diseases, and viral pathway inhibition.

Strategic Manufacturing Advantages of Chinese Manufacturers

How localization, chemical supply chains, and technology drive high-yield, high-purity production for international buyers.

Vertical Raw Material Supply Chain

China is home to the world's most integrated bile acid collection and chemical processing clusters. Access to base components like cholic acid and deoxycholic acid enables a uninterrupted raw material pipeline, safeguarding global buyers against supply shocks.

State-of-the-Art Enzymatic Synthesis

Advanced manufacturers like Chengdu Chenlv Herb incorporate biocatalytic pathways. Multi-enzyme cascade reaction technology replaces heavy metal catalysts, producing clean API profiles with low lithocholic acid (LCA) impurities.

Uncompromising GMP Compliance

With massive investments in automation, factories are designed in strict accordance with WHO GMP, FDA, and EU GMP requirements. Cleanrooms, automated crystallization loops, and continuous processing plants minimize contamination risks.

Product Category

We have integrated research and development, manufacturing, and sales together to deliver optimized natural raw materials and active pharmaceutical ingredients.

Plant Extract & Bioproduction
Contract Manufacturing (OEM/ODM)

About Chengdu Chenlv Herb Co., Ltd.

Established in 2012, Chengdu Chenlv Herb Co., Ltd. (referred to as "Chenlv Herb") operates as a high-tech enterprise specializing in the research, development, production, and sales of botanical extracts and natural pharmaceutical ingredients. We are dedicated to providing high-purity, active, and premium-quality raw materials for pharmaceuticals, health supplements, functional food, animal nutrition, and cosmetics.

By implementing advanced separation, purification, and enzymatic synthesis systems, Chenlv Herb maintains trace impurity profiles in all APIs, including UDCA and similar bile acid derivatives. Our R&D team continuously innovates to meet the regulatory requirements of global drug master files (DMF) and international pharmacopoeias.

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Chengdu Chenlv Herb Facility Overview

2012

Established In
28+
Years of Production Experience
9514 ㎡
GMP Facility Area
100+
Research & Operational Personnel
37+
Standardized Botanical Extracts
62+
Cooperative Strategic Clients
45+
Countries & Regions Served

Why Partner with Chenlv Herb?

We optimize our processes to deliver dependable raw materials that exceed regulatory expectations.

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Innovative Technology

Continuous R&D yields customized ingredient solutions, molecular modification, and enhanced bioavailability techniques.

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High Efficiency

Automated manufacturing lines ensure high yields, rapid turnaround times, and stable batch-to-batch consistency.

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Sustainable Development

Green chemistry principles guide our operations, utilizing eco-conscious sourcing and minimal-waste manufacturing pathways.

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End-to-End Service

From initial laboratory testing to large-scale supply chain logistics, we support you through every stage of development.

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Quality Assurance

Strict QA/QC protocols check for heavy metals, residual solvents, pesticides, and microbial counts using HPLC and GC-MS.

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Enriched Industry Experience

With decades of experience, our technical team understands regulatory documentation, DMF filing, and custom synthesis.

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QA Center Lab Research Technology Integration

Our Hot-Sale Standardized Products

Explore our catalog of high-demand botanical and synthetic ingredients used by leading brands worldwide.

Broad Industrial Applications

Aligning natural biochemical properties with strict end-user sector specifications.

Health Care

Health Care

Driven by the concept of "homology of medicine and food", plant extracts are safe, green, and natural active ingredients for high-demand nutraceutical formulas.

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Pharmaceutical

Pharmaceutical

Providing essential active ingredients, such as purified UDCA, to serve as active components that meet international pharmacopeial limits and clinical protocols.

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Cosmetics

Cosmetics

Highly sought after for anti-aging, moisturizing, and skin-barrier enhancement formulations where natural active ingredients improve safety and efficacy profiles.

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Animal Nutrition

Animal Nutrition

Leveraging bile acids and plant extracts to enhance digestion, liver function, and immunity in livestock and aquaculture systems, replacing antibiotics.

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Health Care Facility Pharmaceutical Testing Cosmetic formulation Animal Nutrition R&D

One-Stop Contract Manufacturing Process

Our standardized workflow from initial chemical request to batch delivery.

Cooperation Intention

01. Intention

Clarify specifications & requirements.
Quotation

02. Quotation

Budgetary planning and terms outline.
Contract Sign

03. Contract

Execution agreement with quality standards.
Customization

04. Sample

Laboratory-scale formulation testing.
Volume Production

05. Production

Scaling to commercial batch sizes.
Inspection

06. Inspection

Analytical certificate generation (CoA).
Shipment

07. Shipment

Safe shipping and regulatory custom clearance.

Global Standards & Regulatory Certificates

All materials comply with critical global standards: ISO9001, ISO22000, HALAL, KOSHER, and FDA.

ISO Certification HALAL Certification KOSHER Certification Quality Management System Certificate HACCP Safety Standard Certificate FDA Facility Registration Certificate

Latest Corporate News & Expo Events

Stay updated with our research breakthroughs and event schedule across international tradeshows.

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With changing supply-demand dynamics at the end of the production season, price fluctuations are drawing significant strategic focus from key industry stakeholders.

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Chenlv Herb CPHI China 2025 Exhibitions

Meet Chenlv Herb at CPHI China 2025 in Shanghai

Join our technical team at CPHI China 2025 to discuss next-generation biotransformation models, custom syntheses, and supply-chain risk mitigation schemes.

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API China Exhibition Invite Corporate Event

Invitation: Discover Bio-solutions at the 92nd API China

We invite global buyers to the China Import and Export Fair Exhibition Hall in Guangzhou to explore our high-purity API offerings and custom synthesis capabilities.

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UDCA Global Sourcing & Regulatory Compliance Guide

Sourcing active pharmaceutical ingredients requires close alignment with international regulatory frameworks. To support pharmaceutical manufacturers and formulation brands, our operations focus on the following key operational sectors:

Impurity Profiling & Control

The control of lithocholic acid (LCA)—a hepatotoxic compound—is critical. Our production limits LCA impurities to well below standard pharmacopoeia limits, verified by precise HPLC assays, ensuring patient safety and regulatory approval.

DMF & Dossier Access

To streamline your drug registration processes, we provide comprehensive Drug Master File (DMF) documentation. This support helps you navigate regulatory requests from agencies such as the US FDA, EMA, and PMDA.

Bespoke Particle Engineering

We offer customized physical properties, including particle size micronization. This control helps target specific dissolution profiles and tablet compaction properties for finished formulations.

Frequently Asked Questions Regarding UDCA Manufacturing

Quick answers to key technical, supply chain, and regulatory questions from international procurement managers.

What is the standard purity profile of your Ursodeoxycholic Acid (UDCA)?
Our synthetic and enzymatically derived UDCA features an HPLC-tested purity profile exceeding 99.0%, compliant with EP, USP, and JP standards. The lithocholic acid (LCA) levels are strictly maintained below 0.1% to guarantee high product safety.
Does your factory provide Drug Master File (DMF) documentation?
Yes, we provide DMF filing numbers and technical dossiers to support regulatory submissions. Our regulatory team assists with the necessary paperwork for regional health authorities.
How does enzymatic synthesis compare to animal-derived bile extraction?
Enzymatic bioconversion uses natural precursor molecules to produce a clean, predictable API. This process ensures Halal, Kosher, and vegan friendliness, while avoiding the batch-to-batch variations common in animal bile sourcing.
What are your packaging options and minimum order quantities (MOQ)?
Standard export packaging consists of 25kg fiber drums lined with dual-layer polyethylene bags. Custom packaging is available upon request. MOQs depend on whether the product is a standard inventory item or a custom-synthesis run.
What is the lead time for standard bulk shipping orders?
In-stock ingredients typically ship within 5-7 business days of order confirmation. Custom manufacturing batches or large-scale contract orders usually require 4 to 6 weeks, which includes full synthesis, purification, and analytical clearance.

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