Doxodet 650 SR is a sustained-release formulation of doxofylline, designed to provide prolonged therapeutic effects through controlled drug release. The tablet contains 650mg of doxofylline, a xanthine derivative with bronchodilatory properties, encapsulated in a specialized matrix to ensure consistent absorption and extended duration of action. The formulation incorporates excipients such as microcrystalline cellulose, magnesium stearate, and hydrophilic colloids to enhance stability, flowability, and disintegration characteristics. The sustained-release mechanism is achieved through a modified-release coating that regulates the dissolution rate, ensuring steady plasma levels of the active ingredient. The tablet’s formulation is optimized for uniformity, content uniformity, and dissolution profile compliance with pharmacopoeial standards. Manufacturing processes focus on precision in blending, compression, and coating to maintain product integrity and efficacy. The final product is designed for stability under varied storage conditions, ensuring shelf-life compliance and consistent performance.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities designed to meet global cGMP standards and produce high-quality sustained-release tablets like Doxodet 650 SR. The facility includes advanced tablet compression lines, coating systems, and granulation units to ensure precision in formulation execution. Sterile processing capabilities are integrated for critical components, ensuring contamination-free production. The manufacturing process adheres to rigorous validation protocols, including process analytical technology (PAT) and quality by design (QbD) principles, to guarantee reproducibility and consistency. Production scalability is achieved through modular manufacturing systems that accommodate both small-scale trials and large-volume commercial batches. Quality systems are reinforced by ISO 9001 certification, with continuous monitoring of critical parameters such as tablet hardness, disintegration time, and dissolution efficiency. The facility is also compliant with FDA, EMA, and WHO guidelines, ensuring adherence to international regulatory frameworks.
Available Strengths and Packaging
Composition: Doxofylline 650mg Sustain Release Tablet
Packaging: 10x10 Alu Alu
Doxodet 650 SR is available in a single strength of 650mg, formulated as a sustained-release tablet. The product is packaged in 10x10 Alu Alu blister packs, providing tamper-evident, moisture-resistant, and light-protective storage. This packaging format ensures product integrity during transportation and storage while facilitating efficient inventory management for pharmaceutical distributors.
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 capabilities include private label manufacturing, where we produce branded formulations under a client’s proprietary name, as well as contract manufacturing for generic and branded products. We support customization of dosage forms, packaging, and labeling to meet specific regulatory and market requirements. Our team collaborates closely with clients to ensure alignment with quality standards, regulatory guidelines, and supply chain logistics. Whether producing for domestic or international markets, we provide scalable solutions that accommodate varying production volumes and compliance needs.
Quality Assurance
Our quality assurance systems are built on a foundation of rigorous testing, analytical validation, and adherence to pharmacopoeial standards. Every batch of Doxodet 650 SR undergoes comprehensive quality control checks, including physical tests for tablet weight, disintegration, and dissolution, as well as chemical assays for active ingredient content and impurity profiling. Analytical validation is performed using HPLC, UV spectrophotometry, and other advanced techniques to ensure method accuracy and reproducibility. Batch testing is conducted in accordance with ICH and USP guidelines, with documented results traceable to regulatory requirements. Our quality systems are integrated with real-time monitoring tools to detect deviations early, ensuring product consistency and compliance.
Regulatory Compliance
Doxodet 650 SR is manufactured in full compliance with cGMP, WHO guidelines, and ISO 9001 standards, ensuring adherence to global regulatory frameworks. Our facility holds certifications from regulatory authorities such as the FDA, EMA, and MHRA, enabling seamless export to international markets. The production process is validated to meet ICH Q7 and Q8 guidelines, with documentation traceable to pharmacopeial standards. Compliance with ISO 14001 for environmental management and ISO 45001 for occupational health and safety further demonstrates our commitment to sustainable and ethical manufacturing. Regulatory submissions for market approval are supported by comprehensive technical documentation, ensuring alignment with regional and global requirements.
Global Supply Capability
Our global supply capability is supported by a robust international distribution network, enabling reliable delivery of Doxodet 650 SR to markets worldwide. We offer bulk supply options tailored to meet the needs of pharmaceutical distributors, exporters, and contract manufacturers, with capacity to scale production to meet large-volume orders. Our logistics partners ensure timely and secure transportation, with compliance to Incoterms and customs regulations for seamless cross-border trade. Supply chain reliability is maintained through redundant inventory systems, real-time tracking, and contingency planning to mitigate disruptions. Whether supplying to emerging markets or established pharmaceutical hubs, we ensure consistent delivery of high-quality products that meet local regulatory and quality standards.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in sustained-release formulation, regulatory compliance, and scalable production. Our commitment to cGMP, ISO certification, and global regulatory alignment ensures that Doxodet 650 SR meets the highest quality standards. The 10x10 Alu Alu packaging format offers logistical efficiency, while our private label and contract manufacturing services provide flexibility for brand-specific requirements. With a focus on reliability, innovation, and customer-centric solutions, we deliver value-driven partnerships that support long-term growth in the pharmaceutical industry.
Bulk Supply Inquiry
We offer bulk supply capabilities for Doxodet 650 SR, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding bulk orders, packaging customization, or regulatory documentation, please contact us at info@delwishealthcare.com.
FAQs
What are the available strengths for Doxodet 650 SR?
Doxodet 650 SR is available in a single strength of 650mg.
What packaging options are available for Doxodet 650 SR?
The product is packaged in 10x10 Alu Alu blister packs for secure and efficient distribution.
What certifications does your facility hold?
Our facility is certified under cGMP, ISO 9001, and complies with WHO and FDA guidelines.
Can you provide private label manufacturing services?
Yes, we offer private label manufacturing to produce branded formulations under your proprietary name.
What quality control measures are in place for Doxodet 650 SR?
Each batch undergoes rigorous testing for content uniformity, dissolution, and impurity profiling.
How does your company ensure regulatory compliance?
We adhere to ICH, USP, and pharmacopoeial standards, with documentation traceable to global regulatory requirements.
What is your capacity for bulk supply?
We provide scalable bulk supply options to meet the needs of pharmaceutical distributors and exporters.
How do you support export compliance for international markets?
Our logistics network ensures compliance with Incoterms and customs regulations for seamless cross-border trade.
Can you accommodate custom packaging requirements?
Yes, we offer packaging customization to meet specific market and regulatory needs.
What is the lead time for bulk orders?
Lead times vary based on order volume and production schedule. Please contact us for a tailored quotation.
