Ursodeoxycholic Acid

Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid used extensively in the treatment of various liver and gallbladder conditions. Recognized for its hepatoprotective and choleretic properties, UDCA is primarily prescribed to dissolve cholesterol gallstones, treat primary biliary cholangitis (PBC), and support liver function in chronic cholestatic conditions. Given the increasing global demand for high-quality UDCA formulations, third-party manufacturing has become a strategic imperative for pharmaceutical brands seeking reliable, cost-effective production solutions.

BluepillExpress, a global leader in pharmaceutical manufacturing and export services, offers robust third-party manufacturing services for Ursodeoxycholic Acid. With world-class infrastructure, strict regulatory compliance, and customizable production options, we empower pharmaceutical businesses to bring top-tier liver care products to market efficiently and safely.

About BluepillExpress

BluepillExpress is a certified third-party pharmaceutical manufacturer and exporter, committed to delivering scientifically formulated and GMP-compliant healthcare products. We cater to domestic and international pharmaceutical brands by offering end-to-end third-party manufacturing solutions across a wide range of therapeutic segments, including hepatology, cardiology, endocrinology, gastroenterology, and more.

With certifications such as WHO-GMP, ISO, and compliance with international pharmacopeias (USP, BP, EP, and IP), BluepillExpress ensures that every batch of Ursodeoxycholic Acid meets the highest standards of safety, purity, efficacy, and consistency.

Therapeutic Applications of Ursodeoxycholic Acid

Ursodeoxycholic Acid is widely prescribed by hepatologists and gastroenterologists for the treatment of:

• Cholesterol Gallstones: UDCA helps dissolve small, non-calcified gallstones in patients who are not candidates for surgery.
• Primary Biliary Cholangitis (PBC): It is the first-line therapy for this autoimmune liver disease, helping to slow disease progression and improve liver function.
• Cystic Fibrosis-Associated Liver Disease: Used to enhance bile flow and reduce liver enzyme levels.
• Non-Alcoholic Fatty Liver Disease (NAFLD): UDCA is sometimes used off-label to manage NAFLD and its progression to NASH.
• Intrahepatic Cholestasis of Pregnancy (ICP): UDCA relieves pruritus and improves liver function in pregnant women with ICP.

By offering scalable manufacturing solutions, BluepillExpress enables pharma companies to address these critical therapeutic needs in various global markets.

Dosage Forms and Strengths Offered

At BluepillExpress, we offer a wide range of Ursodeoxycholic Acid dosage forms and strengths for third-party manufacturing, customized to suit diverse market demands:

• Tablets: 150 mg, 300 mg
• Capsules: 150 mg, 300 mg
• Oral Suspensions: 250 mg/5 mL, especially useful for pediatric or geriatric populations
• Custom formulations: Available on request for specialized markets

We ensure all products are formulated for optimal bioavailability and patient compliance, with film-coated, sugar-free, or enteric-coated options available upon request.

Manufacturing Excellence at BluepillExpress

1. State-of-the-Art Facilities

Our manufacturing units are equipped with modern production lines, automated filling systems, cleanroom environments, and dedicated quality control labs. We maintain separate areas for APIs and finished formulations to avoid cross-contamination, in accordance with GMP standards.

2. Quality Control & Assurance

Quality assurance is at the heart of our third-party manufacturing model. Every batch of Ursodeoxycholic Acid undergoes stringent in-process and post-production quality checks, including:

• Identification and assay by HPLC
• Microbial load testing
• Dissolution and disintegration studies
• Heavy metal and impurity profiling
• Stability studies under ICH conditions

We also provide complete COA (Certificate of Analysis), MSDS (Material Safety Data Sheet), and batch-wise documentation with every shipment.

3. Regulatory Compliance

BluepillExpress adheres to all relevant national and international regulatory norms. Our production is aligned with:

• WHO-GMP guidelines
• ISO 9001:2015 standards
• Schedule M of Indian Drugs and Cosmetics Act
• Compliance with USFDA, MHRA, TGA, and ANVISA guidelines for international exports

We also provide support with dossier preparation, including CTD, ACTD, and regulatory filing for market authorization in various countries.

Customization and Private Labeling

We offer highly flexible private labeling and custom branding services. Whether you’re launching your own brand of liver health supplements or adding to an existing portfolio, we can support you with:

• Customized artwork, logo, and packaging design
• Blister packing, bottle filling, or strip packaging
• Multi-language labeling as per country-specific requirements
• Market-specific brand naming support
• Customized shipping and export documentation

Our goal is to help you build your brand identity while ensuring product integrity.

Why Choose BluepillExpress for Ursodeoxycholic Acid Manufacturing?

Proven Track Record

With years of industry experience and a trusted presence in over 50 countries, BluepillExpress has successfully partnered with pharmaceutical companies across continents for quality-focused third-party manufacturing.

High-Quality Raw Materials

We source Ursodeoxycholic Acid APIs from certified and audited vendors to guarantee purity, efficacy, and consistency.

Scalable Production

Whether your requirement is 10,000 units or 1 million units, we can scale production without compromising turnaround time or product quality.

Timely Delivery

Our supply chain management systems and inventory controls ensure timely procurement, manufacturing, and dispatch to meet your go-to-market timelines.

Competitive Pricing

We optimize production costs without compromising quality, allowing you to maintain healthy margins and market competitiveness.

Global Export Support

BluepillExpress is a trusted export partner for pharmaceutical brands around the world. We handle:

• International freight forwarding
• Regulatory document submission
• Certificate of Pharmaceutical Product (CoPP) issuance
• Embassy attestation
• Third-party inspection and laboratory testing as per import country requirements

We also provide shipping solutions via air or sea with appropriate temperature-controlled logistics for heat-sensitive products.

Packaging Options

We understand that packaging is as important as the formulation. Our Ursodeoxycholic Acid products are available in:

• Alu-Alu and Blister Packs
• HDPE and PET Bottles (for tablets, capsules, and suspensions)
• Custom Carton Packaging with tamper-evident sealing
• Secondary packaging with serialization and barcoding

Packaging is customizable based on brand requirements and regional compliance norms.

Contract Manufacturing Process at BluepillExpress

Our contract manufacturing process for Ursodeoxycholic Acid is transparent, collaborative, and streamlined:

1. Requirement Analysis: Understanding your product specifications, market needs, and packaging preferences.
2. Quotation & Agreement: Finalizing product cost, MOQs, and delivery schedules.
3. Documentation: Signing non-disclosure agreements (NDAs), MOUs, and required regulatory documents.
4. Production & Quality Testing: Manufacturing in GMP-certified units, with rigorous QC/QA protocols.
5. Packaging & Branding: Customized primary and secondary packaging with your brand identity.
6. Dispatch & Logistics: Prompt delivery with tracking, export compliance, and after-sales support.

Partner With BluepillExpress Today

In a global pharmaceutical landscape where quality, speed, and regulatory alignment are paramount, BluepillExpress stands as your reliable partner for Ursodeoxycholic Acid third-party manufacturing. Our client-centric approach, technological innovation, and commitment to regulatory excellence make us the manufacturer of choice for brands looking to scale sustainably and compliantly.

Whether you’re a startup entering the hepatology segment or an established player expanding into international territories, BluepillExpress provides the foundation, flexibility, and quality assurance your brand deserves.