Azidel - XL 200 is a suspension formulation of azithromycin, designed for pharmaceutical manufacturers requiring consistent quality and scalability. The product utilizes a stable, ready-to-use suspension base, ensuring uniform dispersion of the active pharmaceutical ingredient (API) during manufacturing. The formulation incorporates excipients such as a suspending agent, preservative, and flavoring agent to enhance stability, shelf life, and ease of dosing. The DPCO (Directly Palatable Coating) technology ensures the suspension maintains its physical and chemical integrity under standard storage conditions, reducing the risk of API degradation. The formulation is optimized for compatibility with existing manufacturing equipment, minimizing process deviations and ensuring reproducibility. Key characteristics include a pH range suitable for oral administration, low viscosity for easy mixing, and a clear, homogeneous appearance. The suspension’s design supports efficient batch processing, making it ideal for large-scale production while maintaining compliance with pharmaceutical quality standards.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped to produce Azidel - XL 200 with precision and efficiency. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a dedicated sterile processing area for suspension formulations, ensuring contamination-free production. Advanced mixing and homogenization systems are employed to achieve a uniform dispersion of azithromycin, while temperature-controlled environments prevent API degradation during formulation. The production line is scalable to meet varying demand, with the capability to handle bulk raw materials and produce large batches without compromising quality. Quality systems include real-time monitoring, in-process validation, and rigorous documentation to ensure traceability and compliance. The facility is certified under ISO 9001 and ISO 14001, reflecting a commitment to operational excellence and environmental responsibility.
Available Strengths and Packaging
Azidel - XL 200 is available in a single strength of 200mg azithromycin suspension. The product is packaged in a 30ml glass bottle with a mono carton, ensuring safe storage and transport while meeting regulatory packaging requirements. The glass bottle provides airtight containment, protecting the suspension from light and moisture, while the mono carton offers tamper-evident security and clear labeling for compliance. This packaging format is ideal for pharmaceutical suppliers seeking a balance between product protection and cost-effective distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our private label manufacturing capabilities allow clients to produce branded products under their own specifications, with full control over formulation, packaging, and labeling. We support both small-scale and large-volume production, accommodating custom requirements such as API sourcing, excipient selection, and packaging design. Our team of experienced formulation scientists and quality assurance experts ensures seamless integration of client specifications into the manufacturing process, minimizing lead times and maximizing efficiency. Whether you require a single batch or continuous supply, our scalable infrastructure and regulatory expertise position us as a reliable partner for pharmaceutical suppliers and exporters.
Quality Assurance
Quality assurance for Azidel - XL 200 is ensured through a robust system of analytical validation, batch testing, and compliance with international pharmaceutical standards. Every batch undergoes rigorous testing for API content, pH, viscosity, and microbial contamination, with results documented in traceable records. Advanced analytical techniques, including High-Performance Liquid Chromatography (HPLC) and Dissolution Testing, validate the product’s consistency and potency. Our quality control protocols adhere to ICH, USP, and EP guidelines, ensuring compliance with global regulatory frameworks. In-process monitoring and final product inspections are conducted to detect deviations early, while a dedicated quality assurance team oversees corrective actions and continuous improvement. This systematic approach guarantees that Azidel - XL 200 meets the highest standards of purity, safety, and efficacy for pharmaceutical manufacturers.
Regulatory Compliance
Our production of Azidel - XL 200 complies with stringent regulatory frameworks, including GMP, WHO guidelines, and ISO standards. The facility is certified under ISO 9001 for quality management and ISO 14001 for environmental management, reflecting a commitment to sustainable and compliant manufacturing. All processes adhere to WHO prequalification criteria, ensuring the product meets international quality benchmarks for export. Regulatory compliance is further supported by complete documentation, including batch records, stability data, and validation reports, which are essential for regulatory submissions and market access. Our team maintains up-to-date knowledge of global pharmacopeias and regulatory changes, enabling seamless compliance with regional and international requirements.
Global Supply Capability
We provide reliable global supply capabilities for Azidel - XL 200, with a well-established international distribution network and bulk supply capacity to meet diverse market demands. Our logistics infrastructure supports seamless export to over 150 countries, with partnerships ensuring timely delivery and compliance with import regulations. The 30ml glass bottle format is optimized for bulk supply, with packaging designed for efficient storage and transportation. Our supply chain reliability is bolstered by redundant inventory systems, real-time tracking, and contingency planning to mitigate disruptions. Whether you require small or large-volume orders, our scalable production and logistics expertise ensure consistent delivery without compromising quality.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant products like Azidel - XL 200. Our competitive advantages include a proven track record of regulatory compliance, advanced manufacturing capabilities, and a commitment to customer-centric solutions. We offer tailored support for global market entry, with end-to-end services from formulation to distribution. Our ability to scale production, combined with strict adherence to GMP and ISO standards, ensures that clients receive products meeting the highest quality benchmarks. Additionally, our responsive customer service and transparent communication foster long-term partnerships, making us a preferred supplier for pharmaceutical manufacturers seeking reliable, high-quality solutions.
Bulk Supply Inquiry
For bulk supply inquiries or customization requests, please contact our team at info@delwishealthcare.com. Our dedicated sales and technical support team is available to assist with order placement, product specifications, and regulatory documentation.
FAQs
What is the manufacturing process for Azidel - XL 200?
Azidel - XL 200 is produced using a validated suspension formulation process, ensuring uniform dispersion of azithromycin. The API is mixed with excipients in a controlled environment, followed by sterilization and packaging.
Does the product comply with WHO and ISO standards?
Yes, Azidel - XL 200 is manufactured in a facility certified under ISO 9001 and ISO 14001, and it meets WHO prequalification criteria for quality and safety.
Can the packaging be customized?
While the standard packaging is a 30ml glass bottle with mono carton, we offer customization options for labeling, carton design, and bulk packaging upon request.
What are the storage conditions for Azidel - XL 200?
The product should be stored at controlled room temperature (15–30°C) away from moisture and light to maintain stability and efficacy.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and depend on production capacity. For specific requirements, please contact our sales team.
How does your facility ensure contamination-free production?
Our sterile processing area, equipped with HEPA filtration and controlled environmental conditions, ensures contamination-free manufacturing of suspensions like Azidel - XL 200.
Can you accommodate private label manufacturing?
Yes, we provide private label manufacturing services, allowing clients to brand the product under their own specifications.
What certifications does your facility hold?
Our facility is certified under ISO 9001, ISO 14001, and GMP, ensuring compliance with international quality and environmental standards.
How do you ensure product consistency across batches?
Through rigorous in-process testing, batch validation, and real-time monitoring, we ensure consistent quality and potency across all production runs.
What is your export experience?
We have a proven track record of exporting pharmaceutical products to over 150 countries, with expertise in navigating international regulatory and logistical requirements.
