Doxodet Injection is a sterile, aqueous solution containing Doxofylline IP at a concentration of 10mg/mL. The formulation is designed for stability, solubility, and compatibility with standard pharmaceutical processing techniques. The active ingredient, Doxofylline, is a methylxanthine derivative known for its bronchodilatory properties, though this product is tailored for manufacturing and supply rather than direct patient use. The formulation employs high-purity excipients and a pH-adjusted buffer system to ensure chemical stability during storage and transportation. The product’s physicochemical properties, including low viscosity and high solubility, facilitate uniform dispersion and consistent dosing in industrial settings. The manufacturing process prioritizes precision in concentration control, particulate matter reduction, and microbial contamination prevention, ensuring compliance with pharmaceutical standards for injectable solutions.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities for sterile injectable production, including ISO Class 7 and Class 8 cleanrooms, fully automated filling lines, and advanced filtration systems. The facility adheres to stringent Good Manufacturing Practice (GMP) guidelines, ensuring compliance with international pharmaceutical regulations. Sterile processing is achieved through validated aseptic techniques, including terminal HEPA filtration and laminar airflow systems. Production scalability is supported by modular manufacturing units capable of handling bulk supply requirements for domestic and international markets. Quality systems are integrated throughout the process, with real-time monitoring of critical parameters such as temperature, pressure, and pH levels. The facility also complies with ISO 9001:2015 quality management standards, ensuring consistent product quality and traceability.
Available Strengths and Packaging
Composition: Doxofylline IP 10mg Injection
Packaging: 8x5x10 ML
The product is available in a standardized 10mg/mL concentration, packaged in 8x5x10 mL sterile vials designed for efficient storage, transportation, and bulk supply. The packaging dimensions are optimized for compatibility with automated filling systems and logistics handling, ensuring minimal waste and maximum operational efficiency.
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 injectable solutions under their own regulatory frameworks. We support full-scale contract manufacturing, including API sourcing, formulation development, and final product packaging, ensuring end-to-end compliance with global standards. Our services are ideal for pharmaceutical exporters and distributors seeking to expand their product portfolios without investing in in-house production infrastructure. Flexibility in production scales, from small batches to large-volume bulk supply, ensures alignment with market demands.
Quality Assurance
Our quality control systems are designed to meet the highest pharmaceutical standards, with rigorous batch testing and analytical validation at every stage of production. Each batch undergoes comprehensive testing for microbial contamination, particulate matter, pH levels, and active ingredient potency using validated methods such as HPLC and microbial limit testing. Analytical validation ensures consistency in concentration, purity, and stability, while traceability systems enable full documentation for regulatory audits. Quality assurance protocols are aligned with ICH guidelines and WHO recommendations, ensuring compliance for export to regulated markets.
Regulatory Compliance
We adhere to global regulatory frameworks, including GMP, WHO guidelines, and ISO 9001:2015 standards, to ensure product compliance for international distribution. Our manufacturing processes meet the requirements of the FDA, EMA, and PIC/S for pharmaceutical quality assurance. Regulatory documentation, including batch records, stability data, and validation reports, is prepared to support market access in diverse regions. Compliance with ISO 11135:2014 for sterilization and ISO 27001 for information security further strengthens our position as a reliable supplier.
Global Supply Capability
Our export capabilities are supported by an extensive international distribution network, enabling seamless bulk supply to markets across Asia, Africa, Europe, and the Americas. The facility is equipped for large-scale production, with storage capacities to meet long-term demand. Supply chain reliability is ensured through partnerships with certified logistics providers and real-time tracking systems for cargo movement. Bulk supply capacity is scalable, accommodating both short-term orders and long-term contracts. Our commitment to compliance and quality ensures uninterrupted supply, even in high-demand scenarios.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in sterile injectable production, regulatory compliance, and bulk supply efficiency. Our focus on quality assurance, scalable manufacturing, and global regulatory alignment positions us as a dependable partner for expanding market reach. With a proven track record in pharmaceutical manufacturing, we offer competitive pricing, rapid turnaround times, and customized solutions tailored to client needs. Our commitment to innovation and compliance ensures that clients receive products meeting the highest industry standards.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical buyers seeking reliable, compliant, and scalable manufacturing services.
FAQs
What is the manufacturing process for Doxodet Injection?
Doxodet Injection is produced using sterile filtration, aseptic filling, and validated packaging techniques to ensure compliance with GMP standards.
Can Doxodet Injection be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own regulatory framework.
What regulatory standards does your facility comply with?
Our facility adheres to GMP, WHO guidelines, ISO 9001:2015, and regional regulatory requirements for pharmaceutical manufacturing.
What is the minimum order quantity for bulk supply?
We accommodate both small and large orders, with bulk supply capabilities tailored to meet client-specific requirements.
How does your quality assurance system ensure product consistency?
Each batch undergoes rigorous testing for potency, microbial limits, and stability, with documentation compliant with ICH and WHO standards.
Can you support export to international markets?
Yes, our compliance with global regulatory frameworks ensures seamless export to markets in Asia, Africa, Europe, and the Americas.
What is the shelf life of Doxodet Injection?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data provided for regulatory submissions.
How do you ensure supply chain reliability for bulk orders?
Our logistics partnerships and real-time tracking systems ensure timely delivery, with contingency plans to maintain supply chain continuity.
Are there options for contract manufacturing beyond Doxofylline?
Yes, we offer contract manufacturing services for a range of injectable APIs, supporting diverse pharmaceutical product development.
Can you provide documentation for regulatory approvals?
We supply comprehensive documentation, including batch records, stability data, and compliance certificates, to support regulatory submissions.
