Doxidel Plus is a multi-ingredient tablet formulation engineered for stability, bioavailability, and compatibility during manufacturing. The combination of Doxylamine Succinate, Pyridoxine, and Folic Acid is formulated to ensure uniform distribution of active ingredients, with excipients selected to maintain tablet integrity and dissolution profiles. The formulation employs a direct compression method to achieve consistent hardness, disintegration time, and weight variation, while coating technology ensures moisture resistance and prolonged shelf life. The pharmacological synergy of the components is preserved through pH buffering and excipient compatibility testing, ensuring adherence to pharmaceutical standards for active pharmaceutical ingredient (API) stability and tablet performance.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The production process includes advanced tablet compression lines, high-speed coating systems, and automated packaging units to ensure precision and scalability. Sterile processing capabilities are available for critical components, supported by Class 100/1000 cleanrooms and HEPA filtration systems. The facility is designed for large-scale production, with a capacity to handle bulk orders while maintaining consistency in tablet weight, thickness, and dissolution rates. Quality systems include real-time monitoring, in-process testing, and validated cleaning protocols to prevent cross-contamination and ensure product purity.
Available Strengths and Packaging
Composition: Doxylamine Succinate 10mg + Pyridoxine 10mg + Folic Acid 2.5mg Tab
Packaging: 10x10 Strip
Doxidel Plus is available in a single strength formulation, optimized for therapeutic efficacy and uniform dosing. The 10x10 Strip packaging ensures convenient storage and distribution, with tamper-evident seals and desiccant packaging to maintain product stability.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer end-to-end contract manufacturing services, including private label production and third-party manufacturing for pharmaceutical buyers. Our capabilities span formulation development, API sourcing, tablet compression, coating, packaging, and regulatory support. We accommodate custom specifications for dosage forms, excipients, and packaging materials, ensuring compliance with regional and international standards. Our flexible production model supports both small-scale trials and large-volume commercialization, with dedicated teams to manage timelines, quality control, and documentation for regulatory submissions.
Quality Assurance
Our quality assurance framework integrates rigorous batch testing, analytical validation, and compliance with pharmacopeial standards. Each batch undergoes dissolution testing, HPLC analysis, and microbial limit testing to confirm potency, purity, and safety. Process validation, stability testing, and in-process monitoring ensure consistency across production runs. We adhere to ICH guidelines, USP monographs, and WHO specifications, with documented quality records for traceability. Advanced analytical tools, including UV-Vis spectroscopy and X-ray diffraction, validate API integrity and excipient compatibility.
Regulatory Compliance
Doxidel Plus is manufactured in full compliance with GMP, WHO guidelines, and ISO 17025 standards for laboratory accreditation. Our facility holds certifications for cGMP, ISO 9001, and ISO 14001 (environmental management), ensuring adherence to global regulatory frameworks. We maintain documentation for regulatory submissions, including dossiers for FDA, EMA, and local health authorities. Our quality management system (QMS) aligns with ICH Q10 principles for pharmaceutical product lifecycle management, enabling seamless market access in over 50 countries.
Global Supply Capability
We provide robust export capabilities through a well-established international distribution network, with logistics partnerships for cross-border shipments. Bulk supply capacity is supported by automated packaging lines and warehouse systems for efficient order fulfillment. Our supply chain ensures reliability through real-time tracking, inventory management, and contingency planning for disruptions. We cater to both regional and global markets, with compliance-ready documentation for customs clearance and import regulations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in multi-ingredient formulation, scalable production, and regulatory compliance. Our commitment to quality, combined with a proven track record in bulk supply, ensures timely delivery and cost-effective solutions. We offer tailored support for market entry, including documentation assistance and compliance audits, enabling clients to meet stringent regulatory requirements.
Bulk Supply Inquiry
For bulk supply inquiries, contact us at info@delwishealthcare.com to discuss customization, pricing, and logistics.
FAQs
What are the available packaging options for Doxidel Plus?
Doxidel Plus is packaged in 10x10 Strip blister packs with tamper-evident seals and desiccant layers for moisture protection.
Does the manufacturer comply with GMP standards?
Yes, our facility is certified under current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards.
Can Doxidel Plus be customized for specific dosage forms?
Yes, we offer private label and contract manufacturing services with flexibility for custom formulations and packaging.
What quality control measures are in place for batch testing?
Each batch undergoes dissolution testing, HPLC analysis, and microbial limit testing to ensure potency and purity.
Is the product compliant with WHO and FDA guidelines?
Yes, our manufacturing process adheres to WHO guidelines, FDA regulations, and ICH standards for global market access.
What is the minimum order quantity for bulk supply?
We accommodate both small-scale trials and large-volume orders, with flexible MOQs based on client requirements.
How does the company ensure supply chain reliability?
Our logistics network includes real-time tracking, inventory management, and contingency planning for uninterrupted delivery.
Can the manufacturer provide documentation for export compliance?
Yes, we supply complete regulatory documentation, including dossiers for FDA, EMA, and local authorities.
What excipients are used in the formulation?
Excipients are selected for compatibility, stability, and bioavailability, with detailed specifications available upon request.
How is the product’s shelf life ensured?
The formulation includes moisture-resistant packaging and stability testing to guarantee a shelf life of 24 months under recommended storage conditions.
