UDCA Powder

UDCA Powder - Premium Grade Ursodeoxycholic Acid for Pharmaceutical and Nutraceutical Applications

Shaanxi Hongda Phytochemistry stands as a leading manufacturer and supplier of pharmaceutical-grade UDCA Powder, delivering exceptional purity standards that exceed industry expectations. We have over 20 years of professional manufacturing expertise since 2001, and provide goods with 99.8% purity confirmed by HPLC testing, supported by our 100,000-level purification operations and SGS standardised laboratory facilities. Our superior extraction capabilities assure constant quality to EP6, EP8 and EP10.0 standards providing full certification including cGMP, KOSHER, HALAL, FSSC22000 and ISO9001. We address the key supply chain issues for pharmaceutical firms with an annual production capacity of up to 3,000 tonnes and quick stock availability in our 3,000 square metre warehouse for high-purity bile acid derivatives.

Introduction of product

Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid with high therapeutic benefits which is isolated and purified by advanced chromatographic methods. This white crystalline powder is an important raw ingredient for pharmaceutical formulations for hepatobiliary diseases and gallstone dissolving therapy. Our pharmaceutical grade substance is very stable when stored under correct circumstances, guaranteeing continuous bioactivity throughout its shelf-life. The molecular framework of the substance gives optimum solubility qualities critical for formulation development. Our rigid quality control processes ensure batch to batch consistency. Each batch of Ursodeoxycholic Acid Powder is tested rigorously for heavy metals, microbiological contamination and residual solvents to ensure it meets international pharmacopeial requirements and may be included directly into your manufacturing processes.

UDCA Powder Advantages

Unmatched Purity Standards: At a purity level of 99.8% HPLC-verified, our product is free from worries about contaminating bile acid derivatives. This guarantees predictable pharmacokinetic profiles and less formulation headache from contaminants.

Enhanced Solubility Profile: Micronization technology offers a homogeneous particle size distribution, improving the dissolving rate, a key factor in boosting bioavailability for tablet and capsule formulations without the need for sophisticated solubilisation systems.

Regulatory Compliance Guarantee: With multi-standard certification (EP6/EP8/EP10.0), you have the freedom to distribute globally without numerous supplier connections, streamlining your regulatory paperwork procedures.

Improved Stability Profile: Our unique processing processes minimise oxidation susceptibility, prolonging the shelf life of formulations and decreasing reformulation costs associated with degradation problems common in rival goods.

Product Specification

30 years OEM manufacturer

Application of UDCA Powder

Hepatoprotective Formulations: Widely used in pharmaceutical formulations for primary biliary cholangitis and non-alcoholic fatty liver disease, with anti-apoptotic and anti-inflammatory effects that help hepatocytes survive and restore liver function.

Gallstone Management Products: Provides the active pharmaceutical element in oral dissolving therapy for cholesterol gallstones, providing a non-surgical intervention alternative for individuals who are not appropriate for operational procedures.

study Applications in Neuroprotective: It is used in emerging study of neurodegenerative diseases because of its mitochondrial stabilising capabilities and anti-oxidative stress processes, and is a candidate for next-gen cognitive health supplements.

Metabolic Syndrome Interventions: Formulated with UDCA Powder to target insulin resistance and abnormalities of lipid metabolism, backed by clinical data showing improved glycaemic control and cholesterol profiles.

Production Process

Step 1 - Selection of raw materials: High quality bile sources that conform to pharmaceutical standards are chosen, followed by first purification to eliminate proteins and lipids, leading to a concentrated bile acid mixture ready for specialised extraction.

Step 2 - Chromatographic Separation: The use of sophisticated liquid chromatography methods, with specific stationary phases, allows for a selective isolation of ursodeoxycholic acid from other bile acid congeners, with baseline separation and no cross-contamination.

Step 3 – Crystal Refinement: Controlled crystallisation is achieved under exact temperature and solvent conditions, creating high-purity crystals and eliminating residual impurities to provide material with a purity level over 99.5%.

Step 4 - Micronization and Standardisation: Purified crystals are micronised using jet-milling technology to obtain ideal particle size distribution. The micronised material is then subjected to rigorous testing against 15+ quality criteria to ensure batch consistency and formulation compatibility.

Third-Party Test Report

Verification of microbiological safety: The overall plate count is less than 1000 CFU/g and the yeast and mould count is less than 100 CFU/g, independently tested by SGS, which meets the standards of pharmaceutical grade sterility for oral administration goods.

Heavy Metal Testing: Eurofins lab results show lead <0.5 parts per million, arsenic <1.0 parts per million, cadmium <0.5 parts per million, and mercury <0.1 parts per million, assuring patient safety for long-term therapeutic uses.

Pesticide Residue Screening: Full multi-residue screening of 500+ chemicals shows non-detectable levels, indicating regulatory compliance for clean-label medicinal products.

Optical Rotation Testing and Specific Rotation Optical rotation testing verifies the right stereochemical configuration necessary for biological activity and treatment effectiveness.

OEM/ODM Services

Custom Formulation Development Our team of 20+ PhD-level researchers work with your R&D teams to design unique blends that combine UDCA with other complementing hepatoprotective drugs, optimising for synergistic benefits while preserving stability via accelerated ageing trials.

Flexible Packaging Solutions: From pharmaceutical-grade aluminium foil bags (100g-1kg) to bulk fibre drums (25kg), we can meet your unique manufacturing demands with customised labelling, lot coding and documentation to suit your regulatory needs.

Regulatory Document Support: Accelerate your product registration process in the FDA, EMA and NMPA countries by obtaining complete Drug Master Files (DMF), Certificates of Suitability (CEP) and full analytical method validation packages.

Partnership for Quality Assurance Leverage our reserve sample retention program, technical support hotline, and yearly supplier audits for transparent supply chain and proactive problem resolution throughout your collaboration with us.

Why Choose Us?

You have 10+ specialised production lines and 100,000-level clean rooms, no danger of cross-contamination, the most sophisticated bile acid manufacturing infrastructure in China. We have a 20,000 square metre facility with proprietary extraction processes that provide us cost advantages of 15-20% over the industry average, at the same quality standards. We have over 150 specialised experts and inventory on hand, assuring delivery windows of 3-7 days. These are the long lead times that plague pharmaceutical supply chains.

Our SGS-certified laboratory performs over 50 quality tests every batch, and our extensive certification portfolio (cGMP, FSSC22000, ISO22000) pre-qualifies us for your most demanding audit needs, considerably lightening your vendor qualification burden.

FAQ

Q: What distinguishes your UDCA from generic suppliers?

A: Our material consistently exceeds EP10.0 monograph requirements with 99.8%+ purity, supported by third-party verification and complete impurity profiling unavailable from commodity suppliers.

Q: Can you provide regulatory support for new market entries?

A: Yes, we supply complete regulatory dossiers including stability data, manufacturing process descriptions, and GMP compliance certificates tailored to your target jurisdiction.

Q: What minimum order quantities do you require?

A: We accommodate research quantities starting from 1kg with flexible scaling to multi-ton pharmaceutical production volumes.

Q: How do you ensure batch-to-batch consistency?

A: Our Quality Management System employs statistical process control with predefined acceptance criteria, maintaining variation coefficients below 2% across all critical quality attributes.

Contact Us

Ready to secure your pharmaceutical-grade UDCA Powder supply with China's most reliable manufacturer? Contact our technical sales team at duke@hongdaherb.com  for detailed specifications, current pricing, and sample requests.