U-Liv-300 is a pharmaceutical-grade formulation of Ursodeoxycholic Acid (UDCA) at 300mg per tablet, designed for consistent performance and stability in manufacturing processes. The active pharmaceutical ingredient (API), Ursodeoxycholic Acid, is a bile acid derivative known for its role in pharmaceutical applications such as cholestasis management and liver function support. The formulation incorporates excipients that ensure optimal tablet integrity, uniformity, and disintegration properties. The manufacturing process employs advanced compression techniques to produce round, flat, and score-free tablets, ensuring precise dosing and mechanical strength. The formulation is optimized for stability under standard storage conditions, with a focus on maintaining chemical and physical integrity during shelf life. The tablet’s coating (if applicable) or uncoated surface is engineered to meet dissolution specifications, ensuring consistent bioavailability in pharmaceutical applications. The composition adheres to pharmacopeial standards, with rigorous testing for purity, disintegration time, and dissolution efficiency to meet quality requirements for bulk supply and export.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the demands of pharmaceutical-grade production, with state-of-the-art facilities compliant with Good Manufacturing Practices (GMP). The facility includes a dedicated tablet compression line equipped with high-precision equipment for die setting, tablet compression, and packaging. Sterile processing capabilities are available for critical formulations, ensuring contamination-free production. The manufacturing process adheres to GMP standards, with continuous monitoring of critical parameters such as tablet weight, hardness, and disintegration time. Production scalability is achieved through modular design, enabling seamless transitions from small-scale trials to large-volume manufacturing. The facility is equipped with quality systems such as electronic batch records, validation protocols, and real-time data monitoring to ensure process consistency. All manufacturing activities are supported by a robust quality management system (QMS) that ensures compliance with regulatory requirements and customer specifications.
Available Strengths and Packaging
Composition: Ursodeoxycholic Acid 300mg Tab
Packaging: 10x10 Blister
U-Liv-300 is available in a 300mg strength, formulated for pharmaceutical applications requiring precise dosing. The packaging is provided in a 10x10 blister format, ensuring secure storage and tamper-evident protection for bulk supply and export. This packaging design is ideal for distribution channels requiring controlled release and shelf stability.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce branded formulations under a client’s proprietary name, ensuring compliance with regulatory standards. We also provide contract manufacturing for generic and branded products, with flexibility to meet specific dosage forms, packaging requirements, and quality specifications. Our team collaborates closely with clients to design formulations, optimize production processes, and ensure adherence to international pharmacopeial standards. For third-party manufacturing, we maintain full transparency in production, offering audit-ready documentation and traceability throughout the supply chain. This ensures seamless integration with global distribution networks and compliance with buyer-specific requirements.
Quality Assurance
Our quality assurance systems are designed to meet the highest standards of pharmaceutical manufacturing. Each batch undergoes rigorous testing, including identification, purity, disintegration time, and dissolution testing, to ensure compliance with pharmacopeial monographs. Analytical validation is performed using advanced techniques such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry to confirm API content and impurity profiles. Quality control (QC) is integrated into every stage of production, with real-time monitoring of critical quality attributes (CQAs). Batch testing is conducted in accordance with ICH and USP guidelines, ensuring consistency across production runs. All quality records are maintained in electronic format, supporting audit trails and regulatory inspections. Our commitment to quality extends to stability studies, where products are tested under accelerated and long-term conditions to validate shelf life and storage requirements.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001 standards. Our manufacturing processes adhere to ICH Q7 and Q8 guidelines for API and finished dosage forms, ensuring alignment with international pharmacopeial standards. The facility is certified under ISO 9001:2015, demonstrating a commitment to quality management systems. Regulatory compliance is further reinforced through adherence to FDA, EMA, and WHO requirements for export markets. All documentation, including batch records, stability data, and analytical reports, is prepared in compliance with regulatory expectations for pharmaceutical suppliers and exporters. This ensures smooth market access and compliance with buyer-specific regulatory mandates.
Global Supply Capability
Our global supply capability is supported by an extensive international distribution network and robust logistics infrastructure. We specialize in bulk supply for pharmaceutical buyers, with the ability to meet large-scale demand through scalable production and efficient shipping solutions. Export capabilities are enhanced by compliance with international shipping regulations, including temperature-controlled logistics for sensitive formulations. Our supply chain is designed for reliability, with redundant systems to ensure uninterrupted delivery even during disruptions. We serve markets across North America, Europe, Asia, and Africa, with partnerships that facilitate seamless cross-border trade. Bulk supply capacity is supported by dedicated storage facilities and inventory management systems, ensuring timely fulfillment of orders.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, compliant production. Our focus on GMP compliance, regulatory adherence, and scalable manufacturing ensures reliable supply for global markets. As a trusted manufacturer, we offer competitive pricing, fast turnaround times, and customized solutions to meet diverse buyer needs. Our commitment to quality, transparency, and innovation positions us as a preferred partner for bulk supply and export. With a proven track record in pharmaceutical manufacturing, we deliver consistent performance, regulatory compliance, and customer-centric support to strengthen supply chain reliability.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com.
FAQs
What is the manufacturing process for U-Liv-300?
U-Liv-300 is manufactured using advanced tablet compression techniques, ensuring uniformity, disintegration, and mechanical strength. The process adheres to GMP standards and includes rigorous quality checks at every stage.
Can U-Liv-300 be produced in different strengths?
While U-Liv-300 is currently available in 300mg strength, we offer customization for other strengths upon request, subject to regulatory and formulation feasibility.
What packaging options are available for U-Liv-300?
U-Liv-300 is packaged in a 10x10 blister format, ideal for controlled release and secure storage. Other packaging options can be discussed for bulk supply and export.
Does your facility support sterile manufacturing?
Yes, our facility is equipped with sterile processing capabilities to meet the requirements for sensitive pharmaceutical formulations.
What quality standards does U-Liv-300 comply with?
U-Liv-300 complies with WHO, ICH, USP, and EP standards, with full documentation for regulatory submissions and quality audits.
Can you provide export-ready documentation for U-Liv-300?
Yes, we provide complete export documentation, including GMP certificates, batch records, and compliance reports for global markets.
What is your capacity for bulk supply?
Our facility supports large-scale bulk production, with the ability to meet high-volume demands for pharmaceutical buyers and exporters.
How do you ensure supply chain reliability?
We maintain redundant systems, efficient logistics partnerships, and real-time inventory tracking to ensure uninterrupted supply chain operations.
Can you offer private label manufacturing for U-Liv-300?
Yes, we provide private label manufacturing services, allowing clients to brand the product under their own name while maintaining compliance and quality standards.
What is your lead time for bulk orders?
Lead times vary based on order size and production schedule. We offer flexible timelines and prioritize timely delivery to meet buyer requirements.
.webp&w=3840&q=75 "PB-2 Capsule")
