Levodel - OZ is a fixed-dose combination tablet formulated with Levofloxacin 250mg and Ornidazole 500mg, engineered for stability, uniformity, and optimal bioavailability. The formulation leverages advanced excipient compatibility studies to ensure the stability of both active ingredients during storage and transit. Levofloxacin, a broad-spectrum fluoroquinolone, is combined with Ornidazole, a nitroimidazole derivative, to create a synergistic therapeutic profile. The tablet is designed for rapid disintegration, ensuring consistent drug release and enhanced patient compliance. The formulation process involves precise blending of active pharmaceutical ingredients (APIs) with excipients such as microcrystalline cellulose, magnesium stearate, and a disintegrant, followed by compression into a robust, uniform tablet. The product’s formulation adheres to strict pharmaceutical guidelines to maintain potency, purity, and shelf-life compliance.
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 production line includes automated tablet compression machines, high-precision blending systems, and advanced quality control instrumentation to ensure consistency in every batch. Sterile processing capabilities are available for critical components, supported by Class 10,000 cleanroom environments. The facility is designed for scalability, enabling seamless transitions from small-scale development to large-volume commercial production. Quality systems are integrated throughout the manufacturing process, with real-time monitoring of critical parameters such as tablet hardness, disintegration time, and content uniformity. Our commitment to compliance ensures that all products meet international regulatory requirements, making us a trusted partner for pharmaceutical manufacturers.
Available Strengths and Packaging
Composition: Levofloxacin 250mg + Ornidazole 500mg Tab
Packaging: 10x10 Alu Alu
Levodel - OZ is available in a single strength of 250mg Levofloxacin and 500mg Ornidazole, packaged in 10x10 blister packs made of aluminum-aluminum (Alu Alu) foil. This packaging ensures product integrity, protects against moisture and light exposure, and facilitates efficient storage and distribution. The blister format is ideal for pharmaceutical suppliers requiring secure, tamper-evident packaging for both domestic and international markets.
Contract Manufacturing / Third Party Manufacturing
As a leading manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own trademarks, with full customization of packaging, labeling, and formulation specifications. We support both small-scale pilot batches and large-volume commercial production, ensuring consistency and quality across all orders. Our services include formulation development, API sourcing, packaging design, and regulatory documentation assistance, enabling clients to bring products to market efficiently. For pharmaceutical exporters and distributors, our flexible manufacturing solutions provide a reliable partner for meeting global demand.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, stringent batch testing, and adherence to international pharmaceutical standards. Every production batch undergoes comprehensive testing for dissolution, impurity profiling, and potency analysis using high-performance liquid chromatography (HPLC) and mass spectrometry. Quality control systems are integrated at every stage, from raw material inspection to final product release, ensuring compliance with ICH, USP, and EP guidelines. We maintain detailed batch records and conduct stability testing to guarantee shelf-life accuracy. Our commitment to excellence is reflected in our ISO 9001 certification and continuous improvement initiatives, providing pharmaceutical manufacturers with confidence in product quality and regulatory compliance.
Regulatory Compliance
Levodel - OZ is manufactured in full compliance with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 17025 standards. Our facility is audited regularly by international regulatory bodies to ensure adherence to quality and safety protocols. Products are designed to meet the requirements of the FDA, EMA, and other regional authorities, facilitating seamless market access. We maintain detailed documentation for regulatory submissions, including batch records, stability data, and analytical reports. Our compliance with ISO 9001 and ISO 14001 standards ensures environmental responsibility and operational excellence, making us a preferred partner for pharmaceutical manufacturers seeking global regulatory alignment.
Global Supply Capability
We provide robust global supply capabilities, including bulk supply options, international distribution networks, and reliable logistics partnerships. Our export infrastructure supports seamless delivery to over 150 countries, with dedicated teams managing customs compliance, documentation, and shipping logistics. Bulk supply capacity is optimized for large-scale pharmaceutical buyers, with storage facilities designed for long-term inventory management. Our supply chain reliability is ensured through real-time tracking systems, inventory forecasting tools, and contingency planning for disruptions. Whether you require small or large orders, our scalable solutions guarantee timely delivery and compliance with international trade regulations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality production, regulatory compliance, and global supply chain management. Our competitive advantages include advanced manufacturing technology, flexible production capabilities, and a proven track record of delivering reliable products. We prioritize customer collaboration, offering tailored solutions to meet specific market demands. With a focus on innovation and compliance, we empower buyers to achieve their business goals while ensuring product excellence.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing seamless, scalable solutions for pharmaceutical manufacturers and distributors worldwide.
FAQs
What manufacturing standards does Levodel - OZ comply with?
Levodel - OZ is manufactured in compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to international quality and safety standards.
Can Levodel - OZ be produced in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we offer customization options for alternative blister formats, carton packaging, and bulk supply to meet specific market requirements.
What is the shelf life of Levodel - OZ?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
Does your facility support sterile manufacturing processes?
Yes, our facility includes Class 10,000 cleanrooms and sterile processing capabilities for critical components, ensuring product integrity.
Can you provide third-party audit reports for regulatory submissions?
We maintain comprehensive audit records and can provide third-party validation reports to support regulatory submissions.
What are your capabilities for bulk supply?
We offer scalable bulk supply solutions, with production capacity to meet large-volume orders while maintaining quality and consistency.
How do you ensure the stability of Levofloxacin and Ornidazole in the formulation?
Our formulation process includes excipient compatibility studies and stability testing to ensure the active ingredients remain potent and stable under storage conditions.
Can you assist with regulatory documentation for international markets?
Yes, our team provides regulatory documentation support, including batch records, stability data, and analytical reports for global market access.
What is your minimum order quantity for Levodel - OZ?
We accommodate both small and large orders, with minimum quantities tailored to individual client requirements.
How do you ensure supply chain reliability?
Our supply chain is supported by real-time tracking systems, logistics partnerships, and contingency planning to ensure timely and reliable delivery.
