Ofladel - 200 is a formulated solid dosage form containing ofloxacin as the active ingredient, designed for stability, uniformity, and consistent pharmaceutical performance. The tablet formulation incorporates excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure optimal disintegration, flow properties, and compression characteristics. The manufacturing process employs advanced tablet compression techniques to achieve uniform thickness, weight, and hardness, ensuring compliance with pharmaceutical specifications. The product’s formulation is engineered for long-term stability under controlled storage conditions, with a shelf life of up to 24 months when stored at 25°C and 60% relative humidity. The chemical structure of ofloxacin, a broad-spectrum fluoroquinolone, is preserved through rigorous formulation controls to maintain therapeutic potency and avoid degradation during storage.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The production line for Ofladel - 200 includes automated tablet compression systems, high-efficiency mixing equipment, and advanced drying and packaging technologies to ensure precision and consistency. Sterile processing capabilities are available for critical dosage forms, supported by Class 100,000 cleanroom environments and validated HVAC systems. The facility adheres to strict quality control protocols, including real-time monitoring of critical process parameters such as tablet hardness, disintegration time, and active ingredient content. Production scalability is ensured through modular manufacturing units capable of handling bulk orders while maintaining compliance with regulatory requirements. Quality systems are integrated throughout the manufacturing process, with continuous validation of equipment, materials, and procedures to guarantee product integrity and safety.
Available Strengths and Packaging
Composition: Ofloxacin 200mg Tab
Packaging: Ofladel - 200
Ofladel - 200 is available in a single strength of 200mg, formulated as a standard tablet dosage form. The packaging is designed for efficient distribution and storage, with each package labeled to meet global regulatory requirements. The product is supplied in blister packs or cartons, ensuring tamper-evident sealing and protection against environmental contaminants. The packaging format is optimized for bulk supply, supporting seamless integration into pharmaceutical supply chains.
Contract Manufacturing / Third Party Manufacturing
As a leading manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to pharmaceutical buyers. Our capabilities include producing Ofladel - 200 under private brand names, enabling clients to meet regional market demands without compromising quality. We support customization of packaging, labeling, and dosage forms to align with specific regulatory and commercial requirements. Our team collaborates closely with clients to ensure compliance with global standards, including FDA, EMA, and WHO guidelines. Whether you require small-scale trials or large-volume production, our scalable infrastructure and expertise in pharmaceutical formulation ensure timely delivery of high-quality products.
Quality Assurance
Our quality assurance systems are designed to meet the stringent requirements of the pharmaceutical industry, with a focus on consistency, safety, and compliance. Every batch of Ofladel - 200 undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to ensure bioavailability, and microbial limit checks for sterility. Analytical validation of raw materials and finished products is conducted using validated methods, ensuring adherence to pharmacopeial standards. Quality control measures are integrated at every stage of production, from raw material sourcing to final packaging, with documented records for traceability. Our commitment to excellence is reinforced by regular audits, internal quality reviews, and continuous improvement initiatives to maintain the highest standards of product quality.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our manufacturing processes adhere to FDA, EMA, and PIC/S requirements, enabling seamless export to international markets. All documentation, including batch records, stability data, and quality control reports, is maintained in accordance with regulatory expectations. Our facility is regularly inspected by regulatory authorities, and we maintain certifications for pharmaceutical manufacturing, ensuring that Ofladel - 200 meets the safety and efficacy standards required for global distribution.
Global Supply Capability
Our global supply chain is designed to support reliable, timely delivery of Ofladel - 200 to markets worldwide. With a robust international distribution network, we ensure efficient logistics, including air, sea, and land transport, to meet urgent and bulk supply demands. The facility’s production capacity allows for large-scale manufacturing, accommodating orders ranging from small trials to high-volume exports. Our supply chain reliability is supported by partnerships with trusted logistics providers and real-time tracking systems to ensure transparency and compliance. We prioritize adherence to international trade regulations, including customs documentation and phytosanitary requirements, to facilitate smooth cross-border transactions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our proven expertise, compliance-driven approach, and commitment to quality. Our experience in producing Ofladel - 200 ensures that clients receive a product meeting the highest standards of safety and efficacy. As a trusted manufacturer, we offer competitive pricing, flexible production options, and tailored solutions to meet diverse market needs. Our global supply capability and regulatory compliance further enhance our value proposition, enabling partners to access international markets with confidence. By choosing us, you gain a reliable partner dedicated to innovation, quality, and long-term collaboration.
Bulk Supply Inquiry
We offer bulk supply capabilities for Ofladel - 200, supporting large-scale procurement for pharmaceutical buyers. For inquiries regarding bulk orders, please contact our sales team at info@delwishealthcare.com.
FAQs
What certifications does your facility hold?
Our facility is certified under GMP, ISO 9001:2015, and WHO GMP guidelines, ensuring compliance with global pharmaceutical standards.
Can you produce Ofladel - 200 under private label?
Yes, we offer private label manufacturing services, enabling clients to brand the product under their own name.
What are the available packaging formats for Ofladel - 200?
The product is supplied in blister packs or cartons, with options for customized labeling and packaging.
How do you ensure the quality of Ofladel - 200?
Each batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial analysis, to guarantee consistency and safety.
Can you support export to international markets?
Yes, our compliance with FDA, EMA, and WHO standards ensures seamless export to global markets.
What is the shelf life of Ofladel - 200?
The product has a shelf life of up to 24 months when stored at 25°C and 60% relative humidity.
How do you handle bulk supply orders?
We provide scalable production capabilities and logistics support to meet bulk supply demands efficiently.
What is your minimum order quantity?
Minimum order quantities are flexible and can be customized based on client requirements.
Do you offer contract manufacturing services?
Yes, we provide contract manufacturing solutions tailored to pharmaceutical buyers’ specifications.
How can I contact your sales team for bulk inquiries?
For bulk supply inquiries, please email **info@delwishealthcare.com**.
