Azidel 500 is a solid dosage form containing Azithromycin 500mg as the active pharmaceutical ingredient (API), formulated with excipients to ensure stability, uniformity, and disintegration properties. The tablet is designed for direct compression, utilizing a blend of microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to enhance flowability and compressibility. The formulation adheres to stringent pharmaceutical specifications, ensuring consistent content uniformity, dissolution profile, and physical integrity. The DPCO (Directly Observed Treatment, Community-based) designation indicates compliance with specialized manufacturing protocols for controlled-release or adherence-based formulations, though the exact mechanism is defined by the manufacturer’s proprietary process. The tablet’s physicochemical properties, including pH neutrality and moisture resistance, are optimized for long-term storage and stability under varied environmental conditions.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and designed for high-volume production of Azidel 500. The facility includes advanced tablet compression lines, automated blister packaging systems, and dedicated cleanrooms for sterile processing, ensuring minimal contamination risk. The production process adheres to strict quality control protocols, with real-time monitoring of critical parameters such as tablet hardness, weight variation, and disintegration time. Scalability is achieved through modular production lines capable of handling bulk orders while maintaining consistency. Quality systems include validated analytical methods for API content, dissolution testing, and microbial limits, ensuring compliance with International Council for Harmonisation (ICH) guidelines.
Available Strengths and Packaging
Azidel 500 is available in a single strength of 500mg, tailored for pharmaceutical applications requiring precise dosing. The product is packaged in 10x5 blister packs, ensuring tamper-evident sealing, moisture protection, and ease of distribution. This packaging format is ideal for both domestic and international markets, supporting efficient storage and transportation while maintaining product integrity.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services for pharmaceutical buyers. Our capabilities include private label manufacturing, where clients can brand Azidel 500 under their own trademarks, and contract manufacturing for customized formulations. We support flexible production schedules, enabling rapid turnaround for small-to-large orders. Our facility is equipped to handle diverse packaging requirements, including blister, strip, and bulk formats, ensuring compliance with client specifications and regulatory standards.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Each batch undergoes comprehensive testing for API purity, dissolution rate, and physical characteristics using High-Performance Liquid Chromatography (HPLC) and other validated methods. Quality control measures include in-process monitoring, stability testing, and microbial limit checks to ensure product safety and efficacy. We maintain detailed batch records and documentation to meet regulatory audits, with traceability systems in place for full transparency.
Regulatory Compliance
Azidel 500 complies with global regulatory frameworks, including cGMP, World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our manufacturing processes are aligned with FDA, EMA, and PIC/S requirements, ensuring eligibility for export to regulated markets. The product is pre-qualified for WHO prequalification programs, facilitating access to international procurement channels. All documentation, including Certificates of Analysis (CoA) and Certificates of Origin (CoO), is prepared to meet the specific requirements of buyers and regulatory authorities.
Global Supply Capability
We provide reliable bulk supply capabilities with a robust international distribution network spanning Asia, Africa, Latin America, and Europe. Our logistics partners ensure timely delivery through secure, temperature-controlled shipping options, with inventory management systems to maintain stock availability. The facility is equipped for large-scale exports, supporting both short-term orders and long-term contracts. Supply chain reliability is ensured through redundant systems, real-time tracking, and compliance with international shipping regulations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, compliant production. Our competitive advantages include adherence to global standards, scalable manufacturing, and tailored solutions for diverse market needs. We prioritize transparency, offering end-to-end support from production to delivery. With a focus on innovation and reliability, we enable partners to meet regulatory demands and enhance their market competitiveness.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss order requirements, pricing, and logistics.
FAQs
What certifications does Azidel 500 hold?
Azidel 500 is manufactured in compliance with cGMP, ISO 9001:2015, and WHO prequalification standards, ensuring global market access.
Can Azidel 500 be customized for private labeling?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own trademarks.
What is the shelf life of Azidel 500?
The product has a shelf life of 24 months when stored under recommended conditions (15–30°C, RH 45–75%).
Is Azidel 500 suitable for export to regulated markets?
Yes, our compliance with FDA, EMA, and PIC/S guidelines ensures eligibility for export to regulated regions.
What packaging options are available for Azidel 500?
The product is currently available in 10x5 blister packs, with customization options for other formats upon request.
How does your quality control process ensure product consistency?
Each batch undergoes rigorous testing for API content, dissolution, and physical properties using HPLC and other validated methods.
Can you accommodate urgent or small-volume orders?
Yes, our flexible production lines support both small and large orders, with expedited processing for urgent requirements.
What documentation is provided with each shipment?
Each order includes Certificates of Analysis (CoA), Certificates of Origin (CoO), and compliance declarations for regulatory submissions.
How do you ensure supply chain reliability?
We maintain redundant systems, real-time tracking, and partnerships with logistics providers to ensure timely and secure deliveries.
What is your minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be discussed based on production capacity and client requirements.
