Moxidel - CV 375 is formulated as a fixed-dose combination of Amoxycillin and Potassium Clavulanate, ensuring stable and consistent therapeutic efficacy. The formulation employs advanced excipient selection to enhance tablet hardness, disintegration, and dissolution profiles while maintaining chemical stability. Amoxycillin, a broad-spectrum penicillin derivative, is combined with Clavulanate Potassium, a beta-lactamase inhibitor, to overcome resistance mechanisms in Gram-positive and Gram-negative pathogens. The manufacturing process utilizes wet granulation and direct compression techniques to achieve uniform drug distribution, with excipients such as microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate ensuring optimal flow properties and tablet integrity. The final product meets stringent pharmaceutical specifications for dissolution, content uniformity, and physical appearance, ensuring compatibility with global supply chain requirements.
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 facility supports both sterile and non-sterile pharmaceutical production, with dedicated cleanrooms for tablet compression and coating. Advanced equipment, including high-speed tabletting machines, fluid bed dryers, and high-performance liquid chromatography (HPLC) systems, ensures precision in formulation and quality control. Production scalability is achieved through modular design, enabling seamless transitions from small-scale trials to large-volume manufacturing. Quality systems include rigorous validation protocols for equipment, processes, and analytical methods, ensuring reproducibility and regulatory compliance.
Available Strengths and Packaging
Composition: Amoxycillin 250mg + Potassium Clavulanate 125mg Tab
Packaging: 10x1x6 Strip
Moxidel - CV 375 is available in a single strength formulation, optimized for pharmaceutical manufacturers requiring standardized dosing. The 10x1x6 Strip packaging ensures efficient storage, transportation, and retail display while maintaining product integrity.
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 formulation development, API integration, and finished dosage form manufacturing, with flexibility to meet diverse market demands. We support global clients by adhering to regulatory frameworks and providing end-to-end solutions, from raw material sourcing to packaging and labeling. Our team collaborates closely with buyers to ensure compliance with local and international standards, enabling seamless entry into new markets.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmacopeial standards. Each batch undergoes comprehensive testing for potency, dissolution, impurities, and microbial contamination using methods aligned with ICH, USP, and EP guidelines. Advanced analytical tools, including HPLC, UV-Vis spectroscopy, and mass spectrometry, ensure accuracy in quality control. Traceability is maintained through detailed documentation, with batch-specific records accessible for regulatory audits. Continuous improvement programs and regular internal audits reinforce our commitment to excellence in pharmaceutical manufacturing.
Regulatory Compliance
We ensure full compliance with GMP, WHO guidelines, and ISO standards (ISO 9001, ISO 14001) to meet global regulatory requirements. Our processes align with FDA, EMA, and PIC/S guidelines, enabling seamless approval for markets in the EU, US, and Asia-Pacific regions. Documentation is maintained in accordance with ICH Q10 and GMP for pharmaceutical products, ensuring transparency and traceability. Regular audits by third-party agencies and regulatory bodies confirm our adherence to international quality benchmarks.
Global Supply Capability
Our export capabilities are supported by a robust international distribution network, enabling reliable delivery to over 50 countries. Bulk supply capacity is optimized through efficient logistics partnerships and scalable production lines, ensuring timely fulfillment of large orders. Supply chain reliability is guaranteed through real-time tracking systems, inventory management, and contingency planning for disruptions. We prioritize compliance with import regulations and customs protocols to facilitate smooth cross-border transactions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, cost-effective production. Our competitive advantages include ISO-certified facilities, compliance with global regulatory standards, and flexible manufacturing solutions. We offer tailored support for market entry, with a focus on sustainability, innovation, and customer-centric service. Our commitment to excellence ensures that buyers receive products meeting the highest quality and regulatory benchmarks.
Bulk Supply Inquiry
We provide bulk supply capabilities for Moxidel - CV 375. For inquiries, contact our sales team at info@delwishealthcare.com.
FAQs
What certifications does your facility hold?
Our facility is certified under ISO 9001:2015, ISO 14001:2015, and complies with GMP and WHO guidelines.
Can you customize packaging for specific markets?
Yes, we offer customized packaging solutions, including regional language labeling and compliance with local regulations.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with flexible scaling options for larger volumes.
How do you ensure product stability during storage?
Our formulation and packaging are designed to maintain stability under standard storage conditions (25°C, 60% RH).
Are your products compliant with FDA and EMA regulations?
Yes, all products meet FDA, EMA, and PIC/S requirements for international markets.
What is your lead time for production and delivery?
Lead times vary based on order size, but we typically deliver within 4–6 weeks for standard orders.
Can you provide documentation for regulatory approvals?
Yes, we supply complete documentation, including batch certificates, stability data, and regulatory compliance reports.
Do you support private label manufacturing?
Yes, we offer private label services, including branding, packaging, and compliance with local market requirements.
How do you handle quality deviations during production?
We implement corrective and preventive actions (CAPA) to address deviations, with full traceability and root-cause analysis.
What is your policy on raw material sourcing?
We source raw materials from approved suppliers, with rigorous testing for purity, potency, and compliance with pharmacopeial standards.
