U-Liv-150 is formulated with Ursodeoxycholic Acid (UDCA) as the active ingredient, encapsulated in a robust, stable tablet matrix. The formulation employs excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure optimal flow, compression, and disintegration properties. The manufacturing process utilizes direct compression or wet granulation techniques, depending on the required tablet hardness and dissolution profile. The tablet’s physicochemical stability is maintained through controlled pH buffering and moisture protection, ensuring consistent performance during storage and transportation. The formulation is designed to meet pharmacopeial standards for purity, potency, and uniformity, with rigorous testing for disintegration time, dissolution efficiency, and content uniformity.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 quality management systems. The facility supports sterile processing for oral solid dosage forms, including blister packaging, ensuring contamination-free production. Advanced equipment such as high-speed tablet presses, fluid bed dryers, and automated packaging lines enable precise control over critical quality attributes. Production scalability is achieved through modular design, allowing seamless transition from small-scale trials to large-volume commercial batches. The facility adheres to strict validation protocols for process equipment, utilities, and environmental controls, ensuring reproducibility and regulatory compliance.
Available Strengths and Packaging
Composition: Ursodeoxycholic Acid 150mg Tab
Packaging: 10x10 Blister
U-Liv-150 is available in a single strength of 150mg, formulated for consistent therapeutic efficacy. The 10x10 blister packaging ensures tamper-evident protection, ease of handling, and extended shelf life, ideal for both retail and institutional distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label production, and third-party manufacturing services tailored to pharmaceutical buyers. Our capabilities include formulation development, API sourcing, and full-scale production of finished dosage forms, with flexibility to accommodate custom specifications. We support private label manufacturing for brand owners seeking to launch proprietary products, ensuring compliance with regulatory requirements and quality standards. Our team collaborates closely with clients to optimize production timelines, reduce costs, and maintain supply chain efficiency, making us a preferred partner for global pharmaceutical suppliers.
Quality Assurance
Our quality assurance framework integrates advanced analytical techniques and rigorous testing protocols to ensure product integrity. Each batch undergoes in-process testing for critical parameters such as weight variation, hardness, and disintegration time. Final product testing includes high-performance liquid chromatography (HPLC) for active ingredient quantification, microbial limit testing, and dissolution profiling. Analytical validation is performed to confirm method accuracy, precision, and robustness, aligning with ICH and pharmacopoeial guidelines. Quality control systems are supported by real-time data monitoring and traceability tools, ensuring full compliance with global pharmaceutical standards.
Regulatory Compliance
We adhere to stringent regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001:2015, ensuring products meet international quality benchmarks. Our manufacturing processes comply with FDA, EMA, and PIC/S requirements, enabling seamless export to markets in the US, EU, and Asia. Documentation is maintained to support audits by regulatory authorities, with full traceability from raw material sourcing to final product release. Compliance with ISO 14001 environmental management standards further underscores our commitment to sustainable manufacturing practices.
Global Supply Capability
Our global supply chain is designed to meet the demands of international pharmaceutical markets. With a robust network of logistics partners, we facilitate timely delivery to over 50 countries, ensuring compliance with import regulations and customs protocols. Bulk supply capacity is supported by scalable production lines and strategic inventory management, enabling consistent supply chain reliability. We prioritize export compliance through documentation, labeling, and packaging that meet regional regulatory requirements, reducing delays in international shipments.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in cGMP-compliant production, global regulatory compliance, and scalable manufacturing solutions. Our commitment to quality, coupled with a responsive customer service team, ensures seamless collaboration and timely delivery. As a trusted supplier, we provide end-to-end support, from formulation development to global distribution, helping clients achieve market success while maintaining compliance and cost efficiency.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for your pharmaceutical needs.
FAQs
What certifications does your facility hold?
Our facility is certified under cGMP, ISO 9001:2015, and ISO 14001, ensuring compliance with global pharmaceutical and environmental standards.
Can you customize packaging for U-Liv-150?
Yes, we offer customization options for packaging, including alternative blister formats and labeling, subject to regulatory approval.
What is your export capability for U-Liv-150?
We export to over 50 countries, with compliance documentation and packaging tailored to meet regional regulatory requirements.
How do you ensure quality during production?
We implement rigorous quality control measures, including HPLC testing, microbial analysis, and real-time process monitoring to ensure product consistency.
Can you produce U-Liv-150 in different strengths?
Currently, U-Liv-150 is available in 150mg strength. Custom strengths can be developed upon request, subject to regulatory approval.
What is your minimum order quantity for bulk supply?
Minimum order quantities are flexible and depend on production schedules. Please contact us for detailed terms.
How long does it take to receive a bulk order?
Lead times vary based on order size and production capacity. We provide detailed timelines upon order confirmation.
Do you offer contract manufacturing for other products?
Yes, we provide end-to-end contract manufacturing services, including formulation development, API sourcing, and finished dosage form production.
What compliance standards do you follow for regulatory submissions?
We adhere to FDA, EMA, PIC/S, and WHO guidelines, ensuring regulatory submissions meet international requirements.
How do you handle supply chain disruptions?
Our supply chain is designed with redundancy and strategic partnerships to mitigate risks, ensuring uninterrupted delivery even during unforeseen disruptions.
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