Ursodeoxycholic Acid Suspension

Ursodeoxycholic Acid Suspension belongs to the Suspensions category within the Hepatology and Gastroenterology therapeutic segments.

Saar Biotech manufactures this suspension from our manufacturing facility in Baddi.

At Saar Biotech, we manufacture UDCA Suspension using a controlled oral suspension manufacturing process that ensures dose uniformity and palatability.

• API Uniformity: UDCA is uniformly suspended for consistent dosing.
• Taste Masking: Palatable suspension base ensures patient acceptance.
• pH and Stability Management: The active remains chemically stable for 24 months.
• 100ml and 120ml Pack Coverage: Suitable for extended treatment courses.

This suspension is manufactured and supplied by Saar Biotech for the following established clinical indications:

• Cholesterol Gallstones: Dissolution of radiolucent gallstones
• Primary Biliary Cholangitis: Management of PBC
• Cholestatic Liver Diseases: Treatment of intrahepatic cholestasis
• Hepatoprotection: Liver protection in various hepatobiliary disorders

Schedule H — Requires valid medical prescription.

Ursodeoxycholic Acid reduces cholesterol saturation in bile, promotes gallstone dissolution, protects hepatocytes by displacing toxic bile acids, and modulates immune responses.

Manufacturing Integrity

• Suspension Uniformity: UDCA is uniformly suspended for consistent dosing.
• pH Stability: The suspension vehicle is pH-buffered to maintain active stability.

Saar Biotech provides Third-Party Manufacturing for UDCA Suspension from our oral suspension manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Oral suspension manufacturing area with controlled processing, automated bottle filling, capping, labelling, and carton packing lines.
• Capacity: Scalable from brand-entry launches to large commercial batches.
• Quality Lab: In-house GLP-certified lab with HPLC assay, pH, viscosity, MLT, and fill volume checks.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 100ml and 120ml PET or dark amber bottles; sticker label, metallic label, measuring cup, printed cap.
• MOQ: Starting at 5,000–10,000 units per SKU.

1. Warehouse Conditions: Store below 30°C in a cool, dry environment. Do not freeze.
2. Shake Well Before Every Dose: Critical for uniform API distribution.
3. Measuring Cup Use: A calibrated measuring cup ensures accurate dosing.
4. Light Protection: Dark amber bottles and outer cartons protect from light-induced degradation.

Every commercial batch is quarantined until it passes a comprehensive analytical release protocol:

• HPLC Assay: Quantification of UDCA 125mg per 5ml.
• Suspension Uniformity: Sediment behaviour and re-dispersibility testing.
• pH & Viscosity Testing: Suspension stability monitoring.
• Microbial Limit Testing (MLT): IP-compliant microbiological testing.
• Certificate of Analysis (COA): Issued with every B2B batch.

• Gastrointestinal Effects: Mild diarrhoea, nausea.
• Biliary Obstruction: Contraindicated in complete biliary obstruction.
• Contraindications: Known hypersensitivity to any component.

For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for UDCA Suspension, please use the B2B enquiry form below.