Ofladel - OZ is a dual-ingredient tablet formulated with Ofloxacin (200mg) and Ornidazole (500mg), combining a fluoroquinolone antibiotic with a nitroimidazole antiprotozoal agent. The formulation leverages advanced excipient selection to ensure optimal tablet integrity, uniform drug distribution, and stability under varying storage conditions. Ofloxacin, a synthetic broad-spectrum antibiotic, is incorporated using direct compression techniques to maintain its crystalline structure and bioavailability. Ornidazole, a prodrug with antiprotozoal activity, is blended with excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to enhance flow properties and disintegration rates. The tablet’s design ensures rapid dissolution in gastrointestinal fluids, facilitating consistent therapeutic delivery. The combination of these two active ingredients targets both bacterial and protozoal pathogens, making it a versatile option for pharmaceutical manufacturers seeking to address complex infection profiles.
Manufacturing Capability
Our manufacturing infrastructure is engineered to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities equipped for sterile and non-sterile tablet manufacturing. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a controlled environment to ensure product purity and consistency. Advanced tablet compression machinery, including high-speed tabletting machines and precision coating systems, enables the production of high-quality tablets with precise dosing accuracy. For sterile processing, we employ isolator-based systems and laminar airflow technology to prevent cross-contamination, ensuring compliance with ISO 7 and ISO 5 standards. Our production scalability allows for flexible batch sizes, accommodating both small-scale trials and large-volume commercial runs. Quality systems are integrated throughout the manufacturing process, with real-time monitoring of critical parameters such as tablet hardness, disintegration time, and weight variation. This ensures that every batch meets international quality benchmarks and regulatory requirements.
Available Strengths and Packaging
Ofladel - OZ is available in a single strength: Ofloxacin 200mg + Ornidazole 500mg. The product is packaged in 10x10 blister packs, designed for secure storage and easy dispensing. The blister format provides tamper-evident protection, ensuring product integrity during transportation and shelf life. Each blister pack is manufactured using high-barrier materials to safeguard against moisture and light degradation, maintaining the stability of the active pharmaceutical ingredients.
Contract Manufacturing / Third Party Manufacturing
As a trusted 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 dosage forms. We support both domestic and international clients by providing end-to-end solutions, from raw material sourcing to finished product distribution. Our contract manufacturing division adheres to global regulatory standards, ensuring compliance with cGMP, WHO, and ISO guidelines. Whether you require small-batch prototyping or large-scale commercial production, our flexible manufacturing infrastructure enables seamless scalability. Additionally, we offer turnkey services for third-party manufacturers seeking to expand their product portfolios, including formulation development, stability testing, and regulatory documentation support.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, continuous batch testing, and adherence to international pharmaceutical standards. Every production batch undergoes comprehensive quality control checks, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to ensure bioavailability, and microbial limit testing for contamination assurance. In-process controls monitor critical parameters such as tablet weight, hardness, and disintegration time, while final product inspections verify compliance with pharmacopeial monographs. We maintain a dedicated quality assurance team that conducts regular audits and participates in external proficiency testing programs to ensure ongoing excellence. Our facility is certified under ISO 9001:2015, reflecting our commitment to systematic quality management. All quality data is documented and traceable, providing pharmaceutical buyers with transparency and confidence in product consistency.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001 and ISO 14001 standards. Our manufacturing processes are aligned with the requirements of the U.S. FDA, European Medicines Agency (EMA), and other major regulatory bodies, enabling seamless export to international markets. All documentation, including batch records, stability reports, and deviation investigations, is prepared in accordance with regulatory expectations. Our facility is registered with the FDA and EMA, and we maintain active certifications for pharmaceutical production. Additionally, we support clients in navigating regulatory submissions, providing technical documentation and compliance support for market authorization in target regions.
Global Supply Capability
Our global supply chain is designed to deliver reliable, timely, and cost-effective bulk supply to pharmaceutical buyers worldwide. With a well-established international distribution network, we serve markets across Asia, Africa, Latin America, and Europe, ensuring seamless logistics and compliance with import regulations. Our bulk supply capacity is supported by scalable production capabilities, enabling large-volume orders without compromising quality or consistency. We prioritize supply chain reliability through strategic partnerships with logistics providers and real-time tracking systems, ensuring transparent and efficient delivery. Our export capabilities are further strengthened by adherence to international trade standards, including HS code compliance and documentation for customs clearance. For pharmaceutical distributors and exporters, we offer customized supply solutions to meet specific market demands, including regional regulatory requirements and packaging specifications.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant pharmaceutical products. Our commitment to cGMP, ISO certification, and regulatory compliance ensures that your products meet global market standards. With a proven track record in manufacturing complex combination products, we provide reliable bulk supply, competitive pricing, and technical support to enhance your business operations. Our flexible manufacturing capabilities allow for rapid adaptation to market needs, while our dedicated customer service team ensures seamless collaboration throughout the production lifecycle. By choosing us, you gain access to a trusted partner that prioritizes quality, innovation, and long-term partnership in the pharmaceutical industry.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is ready to assist with custom manufacturing, packaging solutions, and global distribution requirements.
FAQs
What certifications does your facility hold?
Our facility is certified under cGMP, ISO 9001:2015, and ISO 14001, ensuring compliance with international pharmaceutical standards.
Can you accommodate custom packaging for Ofladel - OZ?
Yes, we offer customization options for packaging, including blister packs, bottles, and cartons, to meet specific market requirements.
What is the shelf life of Ofladel - OZ?
The product has a shelf life of 24 months when stored under recommended conditions (15–30°C, 60% RH).
Do you provide regulatory documentation for export?
Yes, we supply complete regulatory documentation, including batch certificates, stability reports, and compliance certificates for global markets.
Can you produce Ofladel - OZ in different strengths?
Currently, Ofladel - OZ is available in a single strength (Ofloxacin 200mg + Ornidazole 500mg). Custom formulations can be discussed upon request.
What is your minimum order quantity for bulk supply?
We offer flexible bulk supply options, with minimum order quantities tailored to your production needs.
How do you ensure product quality during manufacturing?
Our quality assurance system includes in-process controls, batch testing, and third-party audits to ensure consistent product quality.
Can you support private label manufacturing for Ofladel - OZ?
Yes, we provide private label manufacturing services, allowing you to brand the product under your own trademark.
What is your export capability for Ofladel - OZ?
We have a global export network and can supply to over 50 countries, adhering to regional regulatory and logistical requirements.
How do you handle supply chain disruptions?
Our supply chain resilience is supported by diversified sourcing, strategic inventory management, and real-time tracking systems to minimize disruptions.
