UDCA Powder

UDCA Powder: Premium Ursodeoxycholic Acid from Shaanxi Hongda Phytochemistry

Elevate your liver health formulations with our premium UDCA Powder—a high-purity ursodeoxycholic acid API clinically proven to manage primary biliary cholangitis (PBC), dissolve cholesterol gallstones, and support metabolic health. Sourced from rigorously controlled cGMP facilities, this crystalline powder delivers ≥99% HPLC-verified purity with minimal impurities (≤0.1% cholic acid). Trusted by leading pharmaceutical manufacturers worldwide, our bulk UDCA Powder ensures batch-to-batch consistency and full compliance with USP/EP, FDA, and EMA standards. Whether you're developing capsules, tablets, or suspensions, this versatile ingredient integrates seamlessly into your production workflow while meeting global pharmacopeial requirements.

Hongda UDCA Powder Manufacturers & Suppliers

At Shaanxi Hongda, we take pride in our cutting-edge production capabilities for product. Our 20,000 square meter facility houses multiple production lines, allowing us to fulfill diverse customization requests. With a dedicated team of over 200 professionals, including 20+ engineers, we guarantee consistent quality and timely delivery.

Why Partner With Us for UDCA Powder?

≥99% Purity & Rigorous Impurity Control

Every batch undergoes third-party HPLC testing to verify ≥99% purity—exceeding USP/EP standards. Our patented synthesis technology minimizes critical impurities like cholic acid (<0.1%) and heavy metals (≤10 ppm), ensuring safer patient outcomes and reduced regulatory risk.

Global Regulatory Compliance Made Simple

Manufactured in FDA-inspected, cGMP/ISO 9001-certified facilities. Full documentation includes:

• Batch-specific Certificates of Analysis (CoA)
• ICH Q3D-compliant heavy metal reports
• DMF/ASMF filings for faster market entry

Formulation-Ready Properties

• Optimal particle size (≤200µm) for uniform blending
• Soluble in ethanol, lipids, and alkaline solutions
• Neutral taste profile for patient adherence

Eco-Conscious & Scalable Supply

Green chemistry processes reduce waste by 30%, while 500+ MT annual capacity guarantees on-time bulk deliveries—even for 50+ MT orders.

Product Parameters

Product Process

Our UDCA Powder production follows a rigorous process:

1. Raw material selection and testing
2. Extraction and purification
3. Crystallization and drying
4. Milling to fine powder
5. Quality control and testing
6. Packaging under controlled conditions

Each step is carefully monitored to ensure the highest quality product for our global clients.

Benefits for Global Buyers

• Reliable supply chain with large inventory
• Competitive factory-direct pricing
• Customization options to meet specific needs
• Comprehensive documentation and certifications
• Expert technical support and formulation guidance
• Fast response times and flexible order quantities
• Stable quality across batches for consistent results
• Long-term partnership opportunities

UDCA Powder Benefits

• Supports liver and gallbladder health
• Aids in dissolving certain types of gallstones
• Improves bile flow and composition
• Potential therapeutic effects in various liver diseases
• High bioavailability and safety profile
• Versatile for pharmaceutical and nutraceutical applications
• Stable under proper storage conditions
• Well-researched and clinically proven efficacy

UDCA Powder Applications

It is widely used in pharmaceutical formulations for treating liver and biliary tract disorders. It's a key ingredient in medications for gallstones, primary biliary cirrhosis, and other hepatic conditions. In the nutraceutical sector, product is incorporated into high-end supplements targeting liver health and digestive wellness. Research is ongoing for its potential in treating metabolic and neurological disorders, expanding its application scope.

Primary Biliary Cholangitis (PBC) Management​​​​​​​

Formulate evidence-based PBC therapies with UDCA’s ability to:

• Reduce alkaline phosphatase (ALP) by 40–50% at 13–15 mg/kg/day doses
• Slow disease progression in early-stage patients
• Combine with glucocorticoids for PBC-AIH overlap syndrome

Cholesterol Gallstone Dissolution:Leverage UDCA’s mechanism to:

• Reduce biliary cholesterol saturation by 70%
• Dissolve radiolucent stones <15mm diameter

Metabolic & Hepatoprotective Support:Develop innovative formulations targeting:

• Non-alcoholic steatohepatitis (NASH) with antioxidant effects
• Prevention of biliary stent obstruction (58% risk reduction)
• Hepatocellular carcinoma preneoplastic lesion inhibition

Quality Assurance

Our SGS-certified laboratory ensures every batch of product meets stringent quality standards.

Certification

We hold Kosher, Halal, cGMP, FSSC22000, ISO22000, ORGANIC (EU/NOP), Vegan, SC, and FDA certifications.

OEM/ODM Services

Customize your product products with our flexible manufacturing capabilities.

Packaging and Delivery

Secure packaging in 25kg drums, with temperature-controlled shipping available.

FAQ

Q: What is the minimum order quantity for product?
A: We offer flexible order quantities to meet your needs. Please contact us for details.

Q: Can you provide stability data for your product?
A: Yes, we provide comprehensive stability data and COAs upon request.

Q: Is your product suitable for pharmaceutical grade applications?
A: Absolutely. Our product meets EP and USP standards for pharmaceutical use.

Q: Do you offer samples before bulk orders?
A: We provide samples for quality evaluation. Contact us to arrange sample shipping.

Q: What is the lead time for bulk product orders?
A: Typical lead time is 3-7 working days, depending on order volume.

Q: Can you assist with regulatory documentation for different markets?
A: Yes, our team can provide necessary documentation to support your regulatory filings.

Contact Us

Ready to elevate your products with premium UDCA Powder? Contact our expert team at duke@hongdaherb.com for personalized assistance and quotations. Experience the Hongda difference in quality, reliability, and service.