Relaxim 400 is a high-purity Rifaximin 400mg tablet formulation engineered for consistent pharmaceutical performance. The active ingredient, Rifaximin, is a semisynthetic rifamycin derivative known for its broad-spectrum antimicrobial activity. The tablet formulation employs a robust excipient matrix, including disintegrants, binders, and coatings, to ensure optimal disintegration, dissolution, and stability under varied storage conditions. The formulation is designed to maintain chemical integrity and bioavailability, with rigorous testing for uniformity of dosage units, hardness, and friability. The manufacturing process prioritizes precision in blending, compression, and coating to meet pharmaceutical-grade standards, ensuring reproducibility and scalability for bulk supply.
Manufacturing Capability
Relaxim 400 is produced using state-of-the-art pharmaceutical manufacturing infrastructure compliant with current Good Manufacturing Practices (cGMP). The facility is equipped with advanced tablet compression lines, high-speed coating systems, and automated packaging solutions to ensure precision and efficiency. Sterile processing capabilities are integrated for critical stages, with controlled environments to prevent contamination. The manufacturing process adheres to stringent quality control protocols, including real-time monitoring of critical parameters such as tablet weight, thickness, and dissolution profiles. Production scalability is ensured through modular manufacturing systems, enabling seamless transitions from small-scale trials to large-volume bulk supply. Facility quality systems are continuously audited to maintain compliance with international standards, ensuring consistent product quality and regulatory readiness.
Available Strengths and Packaging
Composition: Rifaximin 400mg Tablets
Packaging: 10x10 Alu Alu
Relaxim 400 is available in a 400mg strength, packaged in 10x10 aluminum blister packs. The Alu Alu packaging provides superior barrier protection against moisture, light, and microbial ingress, ensuring product stability during storage and transportation. This packaging format is ideal for pharmaceutical suppliers seeking secure, tamper-evident packaging for bulk supply and export. The design facilitates efficient inventory management and compliance with regulatory requirements for pharmaceutical distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our facility supports private label manufacturing, enabling clients to brand Relaxim 400 under their own trademarks while maintaining compliance with global regulatory standards. We provide end-to-end solutions, from raw material sourcing to finished product packaging, ensuring flexibility in production scales and customization options. Our team collaborates closely with clients to align formulations, packaging, and regulatory requirements, making us a preferred partner for pharmaceutical exporters and distributors seeking reliable bulk supply.
Quality Assurance
Relaxim 400 undergoes rigorous quality control systems to ensure compliance with pharmaceutical standards. Each batch is subjected to comprehensive testing, including physical tests (hardness, disintegration, friability), chemical assays for active ingredient content, and microbial limit testing. Analytical validation is performed using advanced techniques such as High-Performance Liquid Chromatography (HPLC) and dissolution testing to confirm bioavailability and uniformity. Quality assurance protocols are aligned with USP, EP, and BP guidelines, ensuring product consistency and safety for global markets. Batch records are meticulously maintained, and all documentation meets regulatory requirements for pharmaceutical suppliers and exporters.
Regulatory Compliance
Relaxim 400 is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 quality management standards. The product adheres to international regulatory frameworks, including FDA, EMA, and PIC/S guidelines, ensuring eligibility for global export and distribution. Our facility holds certifications for cGMP, ISO 14001 (environmental management), and ISO 45001 (occupational health and safety), reflecting our commitment to sustainable and safe manufacturing practices. Regulatory documentation, including batch certificates of analysis (CoA) and stability data, is available for pharmaceutical buyers seeking compliance with local and international market requirements.
Global Supply Capability
Relaxim 400 is designed for seamless global supply, with a robust international distribution network and bulk supply capacity to meet large-scale pharmaceutical demand. Our export capabilities extend to over 50 countries, supported by reliable logistics partnerships and compliance with pharma regulatory standards. The 10x10 Alu Alu packaging format is optimized for efficient storage, transportation, and shelf-life management, ensuring product integrity during transit. Our supply chain infrastructure prioritizes reliability, with contingency plans to address disruptions and maintain consistent delivery timelines. Bulk supply options are tailored to meet the needs of distributors, exporters, and contract manufacturers requiring high-volume, cost-effective solutions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers select Relaxim 400 for its combination of quality, compliance, and scalability. Our manufacturing expertise ensures consistent product performance, while our global supply chain guarantees timely delivery for bulk orders. As a trusted supplier, we offer competitive pricing, flexible packaging options, and end-to-end regulatory support, simplifying the process for pharmaceutical buyers. Our commitment to innovation, sustainability, and compliance positions us as a reliable partner for businesses seeking to expand their market reach through reliable bulk supply and export solutions.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com. Our experts are available to discuss customization, packaging requirements, and regulatory compliance for pharmaceutical exporters and manufacturers.
FAQs
What certifications does Relaxim 400 hold?
Relaxim 400 is manufactured in compliance with GMP, WHO guidelines, ISO 9001:2015, and international regulatory standards, ensuring global market eligibility.
Can Relaxim 400 be customized for private label manufacturing?
Yes, our facility supports private label manufacturing, allowing clients to brand Relaxim 400 under their own trademarks while maintaining quality and compliance.
What is the shelf life of Relaxim 400 in 10x10 Alu Alu packaging?
The product has a shelf life of 24 months when stored under recommended conditions, with packaging designed to preserve stability and integrity.
Is bulk supply available for Relaxim 400?
Yes, we offer bulk supply options tailored to meet the needs of pharmaceutical exporters and distributors, with scalable production capabilities.
What quality control tests are performed on Relaxim 400?
Each batch undergoes testing for physical properties, active ingredient content, microbial limits, and dissolution profiles, ensuring compliance with USP, EP, and BP standards.
Can Relaxim 400 be exported to international markets?
Yes, our regulatory compliance and global distribution network enable seamless export to over 50 countries, meeting local and international pharma standards.
What packaging options are available for Relaxim 400?
Relaxim 400 is available in 10x10 Alu Alu blister packs, optimized for secure, tamper-evident storage and transportation.
How does your facility ensure supply chain reliability?
Our supply chain is supported by logistics partnerships, contingency planning, and real-time monitoring to ensure consistent delivery for bulk orders.
What is the minimum order quantity for Relaxim 400?
Minimum order quantities are flexible and tailored to client requirements, with options for small-scale trials and large-volume bulk supply.
How can I request a sample or bulk supply quote?
Contact our team at info@delwishealthcare.com for detailed information on samples, pricing, and bulk supply options.
