Ofladel Susp is a meticulously formulated suspension containing Ofloxacin at a concentration of 50mg per 5ml, ensuring consistent dosing and stability during storage. The formulation is designed to meet stringent pharmaceutical requirements, with excipients selected for compatibility, solubility, and shelf-life preservation. The suspension’s physical and chemical properties are optimized for uniform dispersion, ensuring ease of manufacturing and consistent product quality. The formulation process involves advanced homogenization techniques to achieve a stable, microbially inert suspension, suitable for large-scale production. The product’s pH and osmolarity are carefully balanced to maintain stability under varying storage conditions, while its viscosity is tailored for efficient mixing and dispensing during manufacturing. The absence of preservatives or stabilizers that could compromise sterility ensures compliance with pharmaceutical standards for parenteral and oral suspensions.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to produce pharmaceutical suspensions with precision and scalability. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a Class 10,000 cleanroom environment for sterile processing, ensuring contamination-free production. Advanced equipment, including high-shear homogenizers and automated filling systems, enables consistent quality and efficiency in large-scale manufacturing. The production process is fully scalable, accommodating both small batch trials and bulk supply demands without compromising product integrity. Quality systems are integrated throughout the manufacturing workflow, with real-time monitoring of critical parameters such as temperature, pH, and particulate matter. The facility is certified under ISO 9001 and ISO 14001, ensuring adherence to international quality and environmental management standards.
Available Strengths and Packaging
Composition: Ofloxacin 50mg/5ml Suspension
Packaging: 60ml With Outer
Ofladel Susp is available in a 60ml single-dose packaging with an outer carton, ensuring secure transport and storage. The 50mg/5ml concentration is ideal for bulk supply, offering flexibility in dosing and formulation. The packaging design is optimized for stability, with airtight seals and tamper-evident features to maintain product integrity.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce under a client’s brand name, ensuring full customization of packaging, labeling, and formulation. We also provide flexible contract manufacturing solutions for both generic and branded products, with the ability to scale production based on market demand. Our team collaborates closely with clients to ensure compliance with regulatory requirements and to meet specific formulation specifications. Whether you require a single batch or long-term supply, our expertise in pharmaceutical manufacturing ensures timely delivery of high-quality products.
Quality Assurance
Our quality assurance systems are designed to meet the highest standards of pharmaceutical excellence. Every batch of Ofladel Susp undergoes rigorous testing, including identification, potency, and dissolution testing, to ensure compliance with pharmacopeial standards. Analytical validation is performed using advanced techniques such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry to confirm purity and consistency. Microbial testing, including sterility checks and endotoxin analysis, ensures the product is free from contamination. All quality control measures are documented and traceable, with batch-specific records maintained for regulatory audits. Our commitment to quality is reinforced by regular internal audits and third-party inspections to ensure continuous improvement.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and International Organization for Standardization (ISO) standards. Our manufacturing processes adhere to ICH (International Council for Harmonisation) guidelines, ensuring alignment with regulatory requirements across markets. The facility is certified under ISO 9001 for quality management and ISO 14001 for environmental management, reflecting our dedication to sustainable practices. Additionally, we maintain compliance with FDA, EMA, and other regional regulatory bodies, enabling seamless export to international markets. All documentation, including batch records and certificates of analysis, is prepared in accordance with regulatory expectations, facilitating smooth approval processes for pharmaceutical buyers.
Global Supply Capability
Our global supply chain is designed to deliver reliable, timely, and scalable pharmaceutical solutions to international markets. With a well-established distribution network, we export to over 50 countries, supported by strategic partnerships with logistics providers and customs clearance experts. Bulk supply capacity is optimized through efficient production planning and inventory management, ensuring consistent availability for long-term contracts. Our supply chain is resilient, with redundant systems in place to mitigate disruptions and maintain operational continuity. Whether you require small-scale exports or large-volume bulk orders, our infrastructure supports seamless delivery while maintaining compliance with international shipping regulations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality suspensions with global compliance. Our commitment to cGMP, ISO certifications, and regulatory adherence ensures that your products meet the highest standards for international markets. The ability to scale production, combined with flexible contract manufacturing options, allows you to respond swiftly to market demands. Our transparent quality assurance processes and reliable supply chain infrastructure provide peace of mind, ensuring consistent product quality and timely delivery. Partnering with us offers a competitive edge through access to advanced manufacturing capabilities and a proven track record of regulatory compliance.
Bulk Supply Inquiry
We offer robust bulk supply capabilities for Ofladel Susp, tailored to meet the needs of pharmaceutical manufacturers and exporters. For inquiries regarding large-scale procurement, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Ofladel Susp comply with?
Ofladel Susp is manufactured in accordance with cGMP, ISO 9001, and WHO guidelines, ensuring compliance with global regulatory requirements.
Can Ofladel Susp be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own name with customized packaging and labeling.
What is the shelf life of Ofladel Susp?
The product has a shelf life of 24 months when stored under recommended conditions (2–8°C), as confirmed through stability testing.
Is Ofladel Susp suitable for export to international markets?
Yes, our compliance with FDA, EMA, and other regional regulations ensures seamless export to global markets.
What quality control measures are in place for Ofladel Susp?
Each batch undergoes rigorous testing, including HPLC, microbial analysis, and dissolution testing, to ensure product consistency and safety.
Can Ofladel Susp be produced in bulk quantities?
Yes, our scalable manufacturing infrastructure supports bulk production to meet large-scale supply demands.
What certifications does your facility hold?
Our facility is certified under ISO 9001, ISO 14001, and cGMP, reflecting our commitment to quality and sustainability.
How do you ensure supply chain reliability?
We maintain a resilient supply chain with redundant systems, strategic logistics partnerships, and real-time monitoring to ensure timely delivery.
What is the packaging specification for Ofladel Susp?
The product is packaged in 60ml single-dose containers with an outer carton, ensuring secure transport and storage.
How can I request a bulk supply of Ofladel Susp?
For bulk supply inquiries, please contact us at **info@delwishealthcare.com**.
