Cepodel CV is formulated as a fixed-dose combination tablet comprising Cefpodoxime Proxetil (200mg) and Potassium Clavulanate (125mg). The formulation is designed to ensure optimal dissolution, bioavailability, and stability during storage. Cefpodoxime, a second-generation cephalosporin, is combined with clavulanate, a beta-lactamase inhibitor, to enhance efficacy against beta-lactamase-producing pathogens. The tablet excipients include microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide, ensuring proper disintegration and flow characteristics during manufacturing. The formulation process involves wet granulation, direct compression, and tablet coating to achieve uniform content, robust mechanical strength, and resistance to environmental factors. The product’s stability is validated through accelerated degradation studies, ensuring shelf-life compliance under standard storage conditions.
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 includes advanced tablet compression lines, high-speed tablet coating systems, and automated packaging units to ensure precision and consistency. Sterile processing capabilities are available for critical components, supported by Class 10,000 cleanrooms and validated HVAC systems. The facility adheres to strict quality control protocols, including in-process testing for particle size, moisture content, and dissolution profiles. Production scalability is achieved through modular manufacturing lines, enabling seamless transitions between small-scale trials and large-volume commercial batches. Comprehensive quality systems, including traceability databases and electronic batch records, ensure full compliance with regulatory requirements and supply chain transparency.
Available Strengths and Packaging
Composition: Cefpodoxime 200mg + Potassium Clavulanate 125mg Tab
Packaging: 10x6 Alu Alu (Blister pack with 10 tablets per foil, 6 foils per blister pack)
The product is available in a single strength, optimized for therapeutic efficacy and dosage uniformity. The 10x6 Alu Alu packaging ensures tamper-evident protection, moisture resistance, and extended shelf-life, making it ideal for both domestic and international distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer end-to-end contract manufacturing and private label services tailored to pharmaceutical buyers’ needs. Our capabilities include formulation development, API integration, and finished dosage form production, with flexibility to meet regional regulatory requirements. We support third-party manufacturing for global markets, providing full documentation, labeling compliance, and regulatory filings. Our scalable production infrastructure enables rapid turnaround for small batches or large-scale commercialization, ensuring cost-effective solutions for distributors and exporters.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmacopeial standards. Each production batch undergoes comprehensive testing for active pharmaceutical ingredient (API) content, disintegration time, dissolution efficiency, and microbial limits. Advanced analytical techniques, including HPLC and UV spectrophotometry, ensure precision in potency and purity assessments. Stability studies are conducted under ICH guidelines to confirm shelf-life and storage conditions. All quality control measures are documented in compliance with USP, EP, and BP standards, ensuring product consistency and regulatory readiness.
Regulatory Compliance
We maintain full compliance with GMP, WHO Prequalification criteria, and ISO 17025 accreditation for analytical laboratories. Our manufacturing processes adhere to global regulatory frameworks, including FDA, EMA, and PIC/S guidelines, ensuring seamless market access. Documentation for regulatory submissions, including DMF files and technical dossiers, is available to support pharmaceutical buyers in obtaining approvals. Regular audits by third-party inspectors and internal quality reviews ensure continuous alignment with evolving regulatory expectations.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply to over 50 countries, supported by strategic partnerships with logistics providers and customs clearance experts. Our facilities are equipped for large-scale exports, with capacity to handle bulk orders for domestic and international markets. Supply chain reliability is ensured through real-time inventory tracking, contingency planning, and compliance with Incoterms 2020. We prioritize timely delivery, with customized shipping solutions to meet urgent demand and maintain market competitiveness.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers select us for our unwavering commitment to quality, regulatory compliance, and scalable production. Our expertise in API integration and finished dosage form manufacturing ensures cost-effective solutions without compromising on safety or efficacy. With a proven track record in global markets, we offer end-to-end support, from formulation to supply chain management, enabling partners to meet market demands efficiently. Our transparent communication, competitive pricing, and dedicated account management further solidify our position as a preferred partner in the pharmaceutical industry.
Bulk Supply Inquiry
For bulk supply inquiries, contact our sales team at info@delwishealthcare.com to discuss customization, pricing, and logistics.
FAQs
What manufacturing standards does Cepodel CV comply with?
Cepodel CV is manufactured under cGMP, ISO 9001:2015, and WHO Prequalification standards, ensuring compliance with global regulatory requirements.
Can the product be customized for different markets?
Yes, we offer private label and contract manufacturing services, allowing customization of packaging, labeling, and regulatory documentation for specific markets.
What is the shelf-life of Cepodel CV?
The product has a shelf-life of 24 months under recommended storage conditions (15–30°C, 60% RH).
Is the 10x6 Alu Alu packaging suitable for export?
Yes, the blister packaging is designed for international distribution, offering moisture resistance, tamper-evidence, and compliance with global export regulations.
Can you provide documentation for regulatory submissions?
We supply complete technical documentation, including DMF files, stability data, and regulatory filings, to support market access.
What is your minimum order quantity for bulk supply?
We accommodate both small-scale trials and large-volume orders, with flexible MOQs based on production requirements.
How do you ensure supply chain reliability?
Our logistics partners and real-time tracking systems ensure timely delivery, with contingency plans to mitigate disruptions.
Can you produce Cepodel CV under different trade names?
Yes, we support private labeling and brand-specific manufacturing to meet the needs of pharmaceutical buyers.
What quality control tests are performed on each batch?
Each batch undergoes API content analysis, disintegration testing, dissolution profiling, microbial limit testing, and stability assessments.
How do you handle compliance with regional regulations?
Our team provides tailored regulatory support, including local labeling, documentation, and compliance with FDA, EMA, and other regional authorities.
