Poxi-100 is formulated as a dispersible tablet containing cefpodoxime proxetil as the active ingredient, ensuring rapid dissolution in water for convenient administration. The formulation is designed to maintain chemical stability and optimal bioavailability, with excipients selected to enhance tablet disintegration and uniformity. The dispersible form facilitates ease of use, particularly in pediatric and geriatric populations, while the tablet’s physicochemical properties support consistent dosing and prolonged therapeutic efficacy. The formulation adheres to pharmaceutical standards for solubility, disintegration time, and dissolution rate, ensuring compatibility with diverse patient needs and dosage 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 production process for Poxi-100 includes precision tablet compression, coating, and packaging, with dedicated lines for sterile processing where required. The facility supports scalable production, enabling seamless transition from small batches to bulk supply while maintaining product quality. Advanced quality control systems, including automated tablet inspection and in-process testing, ensure adherence to stringent pharmaceutical specifications. The manufacturing environment is maintained at controlled temperature and humidity levels to preserve the integrity of active pharmaceutical ingredients (APIs) and excipients.
Available Strengths and Packaging
Composition: Cefpodoxime Proxetil Dispersible 100mg Tab
Packaging: 10x10 Alu Alu
Poxi-100 is available in a 100mg strength, packaged in 10x10 Alu Alu blister packs. The Alu Alu packaging ensures moisture resistance, light protection, and tamper-evidence, making it ideal for storage and transportation. This packaging format is widely adopted in pharmaceutical supply chains for its reliability in maintaining product stability and compliance with regulatory requirements.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include formulation development, API sourcing, and full-scale production of finished dosage forms, with flexibility to accommodate custom specifications. We support global markets by adhering to international regulatory standards, ensuring products meet the requirements of diverse regions. Our team collaborates closely with clients to streamline supply chain integration, reduce time-to-market, and deliver cost-effective solutions for bulk supply and export.
Quality Assurance
Our quality assurance framework encompasses rigorous batch testing, analytical validation, and continuous process monitoring to ensure product consistency and safety. Each batch of Poxi-100 undergoes testing for potency, purity, dissolution, and microbial contamination, with results documented in compliance with ICH and FDA guidelines. Advanced analytical techniques, including High-Performance Liquid Chromatography (HPLC) and UV spectroscopy, validate the API content and stability. Quality control measures are integrated at every stage of production, from raw material sourcing to final packaging, ensuring adherence to global pharmaceutical quality standards.
Regulatory Compliance
We maintain strict compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 17025 standards for laboratory accreditation. Our processes align with regulatory frameworks in key markets, including the FDA, EMA, and PIC/S, ensuring products meet international requirements for export and distribution. Documentation, including batch records, stability data, and regulatory filings, is prepared to support compliance with local and global authorities. This commitment to regulatory adherence enables seamless market entry and long-term supply chain reliability.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply capabilities to meet the demands of global pharmaceutical buyers. Our logistics partnerships ensure timely delivery to over 50 countries, with export capabilities tailored to meet regional regulatory and logistical requirements. The facility’s production capacity supports large-scale orders, while inventory management systems ensure supply chain resilience. We prioritize transparency in sourcing, production, and delivery, offering customized solutions for exporters and distributors seeking consistent, high-quality supply.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in cGMP-compliant production, global regulatory compliance, and scalable manufacturing. Our commitment to quality, combined with flexible supply options and responsive customer support, positions us as a reliable partner for bulk supply and export. With a proven track record in delivering high-standard pharmaceutical products, we offer competitive pricing, timely delivery, and end-to-end solutions to meet the evolving needs of the global market.
Bulk Supply Inquiry
We offer seamless bulk supply capabilities for Poxi-100. For inquiries regarding large-scale procurement, please contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Poxi-100 adhere to?
Poxi-100 is manufactured in compliance with cGMP, ISO 9001:2015, and WHO guidelines, ensuring adherence to global pharmaceutical quality standards.
Can Poxi-100 be customized for different packaging formats?
Yes, we offer flexible packaging solutions, including Alu Alu blister packs, to meet specific market requirements.
What regulatory approvals are required for exporting Poxi-100?
Our products comply with FDA, EMA, and PIC/S regulations, enabling seamless export to international markets.
How does your facility ensure product sterility?
Sterile processing is conducted in ISO Class 7 cleanrooms, with rigorous validation protocols to maintain contamination-free environments.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with scalable production to meet large-scale demands.
Can you provide documentation for regulatory submissions?
Yes, we supply comprehensive documentation, including batch certificates, stability data, and regulatory filings.
How do you ensure the stability of Poxi-100 during storage?
The Alu Alu packaging and controlled manufacturing conditions ensure product stability under standard storage conditions.
What is your lead time for production and delivery?
Lead times vary based on order size, but we prioritize timely delivery with a standard production cycle of 4–6 weeks.
Can you support private label manufacturing for Poxi-100?
Yes, we offer private label solutions, allowing clients to brand the product while maintaining quality and compliance.
How do you handle quality deviations during production?
Our quality control team conducts real-time monitoring and corrective actions to address deviations, ensuring batch integrity and compliance.
