Panol LSR is a dual-action pharmaceutical formulation combining Pantoprazole EC (40mg) and Levosulpride SR (75mg) in a single capsule. Pantoprazole, a proton pump inhibitor (PPI), is formulated as enteric-coated tablets to ensure optimal gastric pH stability and targeted release in the duodenum. Levosulpride, a prokinetic agent with sustained-release (SR) properties, is designed to provide prolonged therapeutic efficacy by modulating gastrointestinal motility. The combination leverages advanced excipient compatibility and controlled-release technology to ensure uniform drug dispersion, dissolution, and bioavailability. Formulation development focused on maintaining chemical stability, minimizing excipient interference, and achieving a homogeneous blend for consistent manufacturing. The capsule formulation is engineered for robustness in storage and transport, with a pH-resistant coating to preserve active ingredient integrity.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The facility includes high-speed tablet compression lines, advanced coating systems for enteric-coated and sustained-release formulations, and automated capsule filling equipment to ensure precision in dosage uniformity. Sterile processing capabilities are available for critical components, supported by ISO Class 7 cleanrooms and validated aseptic techniques. Production scalability is achieved through modular manufacturing lines capable of handling bulk supply demands for global markets. Quality systems include real-time monitoring, in-process controls, and comprehensive documentation to ensure compliance with regulatory requirements.
Available Strengths and Packaging
Composition: Pantoprazole EC 40mg + Levosulpride SR 75mg Cap
Packaging: 10x10 Alu Alu
Panol LSR is available in a fixed-dose strength of 40mg Pantoprazole EC combined with 75mg Levosulpride SR, packaged in 10x10 aluminum blister packs. The Alu Alu packaging ensures moisture resistance, light protection, and tamper-evidence, making it ideal for bulk supply and distribution. Each blister pack contains 10 capsules, with 10 packs per box, ensuring efficient storage and logistics management. The packaging design meets international pharmaceutical standards for stability and shelf-life compliance.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer end-to-end 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 trademark, and contract manufacturing for OEM/ODM requirements. We specialize in handling complex combinations like Panol LSR, ensuring adherence to regulatory guidelines while maintaining cost-efficiency. Our team supports customization of dosage forms, packaging, and labeling, with flexibility to scale production for bulk supply. Whether you require a single batch or large-scale commercialization, we provide seamless integration of quality control, regulatory compliance, and supply chain logistics.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to global pharmaceutical standards. Each production batch undergoes comprehensive testing, including High-Performance Liquid Chromatography (HPLC) for active ingredient quantification, dissolution testing for release profile validation, and microbial limit checks for sterility. In-process controls monitor critical parameters such as tablet hardness, disintegration time, and content uniformity. Final product testing ensures compliance with USP, EP, and pharmacopoeial standards. We maintain detailed batch records and traceability systems to support regulatory audits and supply chain transparency.
Regulatory Compliance
Panol LSR is manufactured in full compliance with cGMP, WHO guidelines, and ISO 9001 standards. Our facility is certified by regulatory authorities such as the FDA, EMA, and PIC/S, ensuring adherence to international quality frameworks. We maintain documentation for regulatory submissions, including stability data, analytical reports, and manufacturing process validations. Our compliance extends to export requirements, with support for registration in target markets and adherence to local labeling regulations. This ensures seamless integration into global supply chains and meets the needs of pharmaceutical exporters and distributors.
Global Supply Capability
We provide reliable bulk supply and export capabilities through a well-established international distribution network. Our logistics partners facilitate timely delivery to over 50 countries, with options for air, sea, and land transport. Bulk supply capacity is supported by scalable production lines and inventory management systems to meet large-volume orders. Supply chain reliability is ensured through real-time tracking, contingency planning, and compliance with international trade regulations. We prioritize consistency in quality, delivery timelines, and cost-efficiency to support long-term partnerships with pharmaceutical buyers.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in complex formulations, regulatory compliance, and bulk supply efficiency. Our commitment to cGMP standards, advanced manufacturing technology, and global distribution networks ensures competitive advantage. We offer tailored solutions for private label and OEM requirements, with transparent pricing and flexible order volumes. Our dedicated support team provides guidance on regulatory submissions, quality assurance, and supply chain optimization, making us a strategic partner for pharmaceutical manufacturers seeking reliable, scalable solutions.
Bulk Supply Inquiry
For bulk supply inquiries, contact our sales team at info@delwishealthcare.com to discuss customization options, pricing, and logistics for Panol LSR and other formulations.
FAQs
What manufacturing standards does Panol LSR comply with?
Panol LSR is manufactured under cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical quality standards.
Can Panol LSR be produced in different packaging formats?
Yes, we offer customization for packaging, including Alu Alu blister packs and other formats, to meet regional and market-specific requirements.
What is the shelf life of Panol LSR?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data validated per ICH guidelines.
Does your facility support sterile manufacturing?
Yes, our ISO Class 7 cleanrooms and aseptic processing capabilities ensure sterile manufacturing for critical components.
Can you handle private label manufacturing for Panol LSR?
Absolutely. We provide private label solutions, including branding, labeling, and packaging customization for global markets.
What quality tests are performed on Panol LSR?
Each batch undergoes HPLC analysis, dissolution testing, microbial limit checks, and physical property assessments to ensure compliance.
Are you certified for international export?
Yes, our facility is certified by FDA, EMA, and PIC/S, with support for export documentation and regulatory registration.
How do you ensure supply chain reliability?
We use real-time tracking, logistics partnerships, and contingency planning to guarantee timely and consistent bulk supply.
Can you scale production for large-volume orders?
Our modular manufacturing lines and inventory systems support scalable production for bulk supply and global distribution.
What is the minimum order quantity for Panol LSR?
Minimum order quantities are flexible, with options for small trials and large-scale commercial orders based on client requirements.
