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Ursodeoxycholic Acid Structure

PRODUCT TYPE

API

GRADE

USP / BP

CHEMICAL FORMULA

C24H40O4

IUPAC NAME

(3α,5β,7β)-3,7-Dihydroxycholan-24-oic acid

CAS NO

128-13-2

MOLECULAR WEIGHT

392.57 g/mol

CHEMICAL CLASS

Secondary bile acid

THERAPEUTIC CLASS

Hepatoprotective agent

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance White to off-white crystalline powder
Solubility Slightly soluble in water; freely soluble in ethanol
Melting Point 178 – 182°C (with decomposition)
pH (1% aqueous solution) 4.0 – 5.0

Product Description

Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid and a key hepatoprotective agent. It is used to dissolve gallstones, improve bile flow, protect liver cells, and reduce cholesterol saturation in bile. It is one of the most widely prescribed agents for cholestatic liver diseases and gallstone prevention.

How Ursodeoxycholic Acid Works

Ursodeoxycholic Acid modifies the bile acid composition and reduces hepatocellular injury by decreasing toxic hydrophobic bile acids. It stabilizes hepatocyte membranes, protects mitochondria from oxidative stress, and promotes choleresis (bile secretion). UDCA also reduces cholesterol absorption and secretion into bile, preventing gallstone formation.

Use(s)

Adverse Effects

Why choose Salius for Ursodeoxycholic Acid?

  1. WHO-GMP Certified Manufacturing
    Manufactured in WHO-GMP, ISO 9001:2015, and FDA-audited facilities with stringent quality assurance, validated purification, and crystallization processes.
  2. Consistent Quality and Reliability
    Pharmaceutical-grade UDCA meeting USP/BP standards with validated analytical methods, impurity profiling, and stability data for global registrations.
  3. Global Export Experience & Documentation Support
    Full regulatory support including DMF (Open Part), stability data, CTD/ACTD dossiers, and certificates (CoA, TDS, MSDS, GMP, and origin) for seamless registration and export.
  4. Documents We Provide
  5. Trusted Hepatoprotective API Supplier
    With proven expertise in chronic therapy APIs, Salius ensures long-term reliability and consistent quality for liver health formulations worldwide.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

Pharmaceutical Grade conforming to USP / BP standards, suitable for tablet and capsule formulations.

Comprehensive documentation including CoA, MSDS, TDS, GMP Certificate, DMF (Open Part), Stability Data, and CTD dossier upon request.

Exported to LATAM, MENA, CIS, Africa, and Southeast Asia, with expanding regulatory approvals worldwide.

Yes. Our regulatory team prepares and customizes CTD/ACTD dossiers and analytical data per importing country requirements.

Dispatch within 10–15 working days depending on stock status and documentation readiness.

Packed in 25 kg fiber or HDPE drums with double polyethylene liners to ensure stability and compliance with international transport standards.

Place an Order or Request a Quote from Salius Pharma

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Whether you need Active Pharmaceutical Ingredients (APIs), finished formulations, or regulatory support, our team is ready to provide dependable, compliant, and cost-effective solutions tailored to your market needs.

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