Cepodel-O is a fixed-dose combination tablet formulated with Cefpodoxime Proxetil 200mg and Ofloxacin 200mg, designed for pharmaceutical manufacturers seeking a stable, high-quality antibiotic formulation. The tablet formulation incorporates excipients such as microcrystalline cellulose, calcium hydrogen phosphate dihydrate, and magnesium stearate to ensure optimal disintegration, dissolution, and tablet integrity. The combination of Cefpodoxime, a third-generation cephalosporin, and Ofloxacin, a fluoroquinolone, provides synergistic antibacterial activity against a wide range of Gram-positive and Gram-negative pathogens. The formulation is engineered to maintain stability under varied storage conditions, ensuring consistent potency and shelf life. The tablet’s physicochemical properties, including uniform content uniformity and robust binding, are critical for meeting pharmaceutical specifications and enabling scalable manufacturing.
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 process for Cepodel-O includes advanced tablet compression technology, ensuring precise dosing and uniformity. Sterile processing capabilities are maintained through dedicated cleanroom environments, with controlled temperature, humidity, and particulate levels to prevent contamination. The facility supports large-scale production, enabling seamless scalability to meet bulk supply demands. Quality systems are integrated throughout the manufacturing lifecycle, with real-time monitoring of critical parameters such as tablet hardness, disintegration time, and weight variation. Our pharmaceutical manufacturers adhere to rigorous validation protocols to ensure reproducibility and compliance with global regulatory requirements.
Available Strengths and Packaging
Composition: Cefpodoxime 200mg + Ofloxacin 200mg Tab
Packaging: 10x10 Alu Alu
Cepodel-O is available in a single strength of 200mg for both active ingredients, packaged in 10x10 aluminum blister packs. The aluminum packaging ensures protection against moisture, light, and microbial ingress, maintaining product integrity during storage and transportation. This packaging format is ideal for pharmaceutical suppliers requiring secure, tamper-evident packaging for bulk supply and distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted pharmaceutical manufacturer, we offer comprehensive contract manufacturing and third-party manufacturing services tailored to meet the needs of global buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own trademarks, with full flexibility in formulation, packaging, and labeling. We support both small-scale pilot batches and large-volume production, ensuring compliance with regulatory standards and client specifications. Our services cater to pharmaceutical exporters and distributors seeking reliable, cost-effective solutions for market entry. By leveraging our expertise in API sourcing, formulation development, and packaging, we enable partners to streamline their supply chains and enhance competitiveness in international markets.
Quality Assurance
Our quality assurance systems are designed to ensure consistency, safety, and compliance with pharmaceutical standards. Every batch of Cepodel-O undergoes rigorous testing, including in-process controls for particle size, moisture content, and dissolution profiles. Analytical validation methods, such as HPLC and UV spectrophotometry, are employed to confirm active ingredient content and purity. Quality control measures also include microbial limit testing, heavy metal analysis, and dissolution testing to meet pharmacopeial requirements. Our pharmaceutical manufacturers maintain detailed documentation for traceability and regulatory audits, ensuring adherence to Good Manufacturing Practices (GMP) and international quality benchmarks.
Regulatory Compliance
Cepodel-O is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 standards. Our facility is certified by regulatory authorities in multiple jurisdictions, enabling seamless export to global markets. We adhere to strict documentation protocols, including batch records, stability data, and regulatory filings, to support compliance with FDA, EMA, and other international frameworks. Our pharmaceutical manufacturer ensures that all products meet pharmacopeial standards, with regular audits and inspections to maintain regulatory alignment. This commitment to compliance positions us as a reliable supplier for pharmaceutical exporters and contract manufacturers requiring trusted, compliant products.
Global Supply Capability
Our global supply chain is designed to meet the demands of international pharmaceutical buyers, with robust export capabilities and a well-established distribution network. We offer bulk supply options to accommodate large orders, supported by a logistics infrastructure that ensures timely delivery to key markets. Our pharmaceutical manufacturer maintains strategic partnerships with freight forwarders and customs brokers to facilitate smooth cross-border shipments. The facility’s production capacity allows for scalable supply, with flexibility to adjust output based on market demand. Our supply chain reliability is further enhanced by real-time tracking systems and contingency planning, ensuring uninterrupted delivery even in challenging conditions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, compliant manufacturing. As a trusted manufacturer and supplier, we offer competitive pricing, fast turnaround times, and tailored solutions to meet diverse market needs. Our commitment to GMP compliance, regulatory alignment, and supply chain reliability ensures that clients receive products that meet global standards. By partnering with us, buyers gain access to a scalable, reliable source of Cepodel-O, supported by a dedicated team focused on excellence in pharmaceutical manufacturing.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com. Our pharmaceutical manufacturer is equipped to handle large-scale orders, ensuring timely delivery and compliance with international standards.
FAQs
What is the manufacturing process for Cepodel-O?
Cepodel-O is manufactured using advanced tablet compression technology, with strict adherence to cGMP and ISO standards to ensure consistency and quality.
Can Cepodel-O be customized for private labeling?
Yes, our private label manufacturing services allow clients to brand the product under their own trademark, with full customization options.
What regulatory certifications does your facility hold?
Our facility is certified under GMP, ISO 9001:2015, and complies with WHO and FDA guidelines, ensuring global regulatory alignment.
What is the shelf life of Cepodel-O?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Can you provide bulk supply options for Cepodel-O?
Yes, we offer bulk supply capabilities to meet the demands of pharmaceutical exporters and distributors.
What quality control measures are in place for Cepodel-O?
Every batch undergoes rigorous testing, including dissolution, microbial limit, and heavy metal analysis, to ensure compliance with pharmacopeial standards.
How do you ensure packaging integrity for Cepodel-O?
The 10x10 Alu Alu packaging is designed to protect the product from moisture, light, and contamination, ensuring stability during transportation.
What is the minimum order quantity for Cepodel-O?
Minimum order quantities are flexible and can be customized based on the buyer’s requirements and production capacity.
Can you support export to specific regions?
Yes, our global supply network enables seamless export to all major markets, with compliance documentation tailored to regional regulations.
How do you handle supply chain disruptions?
We maintain contingency plans, including diversified suppliers and logistics partners, to ensure uninterrupted supply chain reliability.
