Azidel-250 is a robust pharmaceutical formulation designed for industrial-scale production, featuring azithromycin as the active pharmaceutical ingredient (API) in a 250mg dosage form. The tablet formulation incorporates excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure optimal disintegration, flow properties, and stability during storage. The manufacturing process employs direct compression techniques to achieve uniform tablet hardness and dissolution rates, ensuring consistent bioavailability. The formulation is engineered to maintain stability under a range of environmental conditions, with a shelf life of up to 24 months when stored in controlled conditions. Key pharmaceutical characteristics include a rapid disintegration time (≤15 minutes), uniform content uniformity (±5% variation), and compliance with pharmacopoeial dissolution specifications. The tablet’s design balances mechanical strength with ease of packaging, making it suitable for blister and strip packaging formats.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce Azidel-250 at scale, leveraging state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP). The facility includes advanced tablet compression lines, high-speed blister packaging machines, and automated quality control systems to ensure precision and consistency. Sterile processing capabilities are maintained through dedicated cleanrooms (ISO Class 7/8) for critical steps, ensuring contamination-free production. The facility adheres to strict GMP standards, with regular audits and validation protocols to guarantee product integrity. Production scalability is supported by modular manufacturing units capable of handling bulk orders ranging from 10,000 to 500,000 tablets per batch. Quality systems include real-time monitoring of critical parameters such as compression force, tablet weight, and disintegration time, ensuring adherence to pharmacopeial specifications.
Available Strengths and Packaging
Composition: Azithromycin 250mg Tab
Packaging: 10x6 Blister
Azidel-250 is available in a single dosage strength of 250mg, tailored for broad therapeutic applications. The 10x6 blister packaging format ensures secure, moisture-resistant storage while facilitating efficient distribution and retail display. This packaging design is ideal for both bulk supply and retail-ready products, offering tamper-evident protection and extended shelf life.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services to pharmaceutical buyers seeking to streamline production and supply chains. Our private label manufacturing capabilities allow clients to produce branded or generic formulations under their own trademarks, with full flexibility in packaging, labeling, and regulatory compliance. For contract manufacturing, we provide end-to-end solutions, including API sourcing, formulation development, tablet compression, and packaging, ensuring adherence to client specifications and global regulatory standards. Third-party manufacturing partners benefit from our scalable production infrastructure, rigorous quality control, and expertise in pharmaceutical compliance, enabling seamless integration into existing supply chains.
Quality Assurance
Quality assurance for Azidel-250 is governed by a multi-tiered system encompassing raw material testing, in-process controls, and final product validation. Each batch undergoes rigorous analytical testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing to confirm bioavailability, and microbial limit testing to ensure sterility. Batch testing protocols are validated against ICH and USP guidelines, with documentation traceable to ISO 9001 standards. Analytical validation includes method development, accuracy, precision, and stability studies to ensure long-term reliability. All quality control data is integrated into a centralized database, enabling real-time traceability and compliance with Good Manufacturing Practices (GMP).
Regulatory Compliance
Azidel-250 is manufactured in full compliance with global regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001 and ISO 14001 standards. The production process adheres to the requirements of the U.S. FDA, EMA, and WHO for pharmaceutical quality assurance, ensuring market access in over 150 countries. Regulatory documentation, including batch records, stability data, and compliance certificates, is prepared to meet the specifications of international regulatory authorities. Our facility is regularly inspected by third-party auditors and regulatory bodies, ensuring continuous alignment with evolving standards.
Global Supply Capability
Delwis Healthcare delivers bulk supply capabilities with a robust international distribution network, enabling seamless export to over 80 countries. Our logistics partners ensure timely delivery of Azidel-250 through air, sea, and land routes, with customs documentation and compliance support to expedite clearance. Bulk supply capacity ranges from 10,000 to 500,000 tablets per order, with flexibility to accommodate urgent or large-volume requests. Supply chain reliability is maintained through redundant inventory systems, real-time tracking, and partnerships with trusted freight forwarders. The company’s export expertise ensures compliance with import regulations, including FDA, EMA, and WHO requirements, reducing delays and ensuring product availability in target markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select Delwis Healthcare for its unmatched combination of regulatory compliance, scalability, and reliability. Our commitment to cGMP standards and ISO certifications ensures product quality that meets global market demands. The company’s bulk supply capabilities and flexible manufacturing options enable clients to optimize cost-efficiency and market reach. Additionally, Delwis Healthcare provides dedicated customer support, from regulatory consultancy to logistics coordination, ensuring seamless integration into clients’ supply chains.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply of Azidel-250 to meet the needs of pharmaceutical manufacturers and exporters. For inquiries regarding bulk orders, production timelines, or customization options, contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delwis Healthcare follow for Azidel-250?
Our production adheres to cGMP, ISO 9001, and WHO guidelines, ensuring compliance with global regulatory requirements.
Can Azidel-250 be produced in different packaging formats?
While the standard packaging is 10x6 blister, we offer customization for alternative formats upon client request.
What is the shelf life of Azidel-250 under standard storage conditions?
The product has a shelf life of 24 months when stored in a cool, dry environment (25°C ±5°C, 60% RH).
Does Delwis Healthcare provide contract manufacturing services for Azidel-250?
Yes, we offer full-scale contract manufacturing, including formulation, compression, and packaging.
What quality control tests are performed on Azidel-250?
Each batch undergoes HPLC analysis, dissolution testing, microbial limit testing, and physical property checks.
Can Azidel-250 be exported to international markets?
Yes, our regulatory compliance ensures export to over 150 countries, including the EU, US, and Asia-Pacific regions.
What is the minimum order quantity for bulk supply?
Minimum orders start at 10,000 tablets, with flexibility for larger volumes.
How does Delwis Healthcare ensure supply chain reliability?
We maintain redundant inventory systems and partner with trusted logistics providers to ensure timely delivery.
Is customization available for labeling and packaging?
Yes, we support private label manufacturing and customized packaging solutions.
What support is available for regulatory documentation?
Our team provides complete regulatory documentation, including batch records and compliance certificates.
