Rabenac is formulated as a fixed-dose combination tablet combining Aceclofenac (200mg) and Rabeprazole (20mg), designed for optimal stability, uniformity, and bioavailability. The formulation leverages advanced excipient selection to ensure compatibility between the non-steroidal anti-inflammatory drug (NSAID) Aceclofenac and the proton pump inhibitor (PPI) Rabeprazole, minimizing potential interactions. The tablet matrix incorporates hydrophilic and hydrophobic excipients to achieve consistent disintegration and dissolution profiles, ensuring reliable therapeutic performance. Manufacturing processes focus on precise blending of active pharmaceutical ingredients (APIs) with excipients, followed by compression into tablets with a controlled-release coating to enhance gastric protection. The formulation is designed to meet stringent pharmaceutical standards for hardness, friability, and dissolution efficiency, ensuring compliance with regulatory requirements for dosage form integrity.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities for pharmaceutical tablet production, including high-speed tablet presses, fluid bed coating systems, and automated packaging lines. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a Class 10,000 cleanroom environment for sterile processing, ensuring contamination-free production. Advanced quality control systems, including spectroscopic and chromatographic analysis, are integrated into the manufacturing workflow to validate raw material purity and finished product consistency. The production line supports scalability for bulk supply, with the capacity to meet global demand through flexible batch sizes and efficient process optimization. Rigorous validation protocols for equipment, processes, and environmental controls ensure compliance with international pharmaceutical standards, enabling seamless integration into supply chains for manufacturers, exporters, and contract producers.
Available Strengths and Packaging
Composition: Aceclofenac 200mg + Rabeprazole 20mg Tab
Packaging: 10x10 Alu Alu
Rabenac is available in a single strength of Aceclofenac 200mg combined with Rabeprazole 20mg, packaged in 10x10 aluminum blister packs. The blister packaging ensures product stability, tamper-evidence, and extended shelf life, making it ideal for bulk supply and distribution. The Alu Alu packaging format is designed for efficient storage, transportation, and retail display, aligning with global pharmaceutical packaging standards.
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 facility supports private label manufacturing, enabling clients to brand Rabenac under their own trademarks while maintaining compliance with regulatory frameworks. We provide end-to-end solutions, from API sourcing and formulation development to packaging and quality assurance, ensuring seamless integration into existing supply chains. Our team specializes in producing high-quality combination tablets for global markets, with expertise in adhering to FDA, EMA, and WHO guidelines. Whether you require customized packaging, dosage form adjustments, or scalable production, our flexible manufacturing capabilities cater to diverse B2B requirements, positioning us as a reliable partner for exporters and contract manufacturers.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Every production batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing to ensure bioavailability, and microbial limit checks for contamination control. In-process quality control measures monitor critical parameters such as tablet hardness, disintegration time, and content uniformity, ensuring compliance with USP, EP, and BP monographs. Traceability systems and documented batch records guarantee transparency and regulatory compliance. Additionally, our facility is certified under ISO 9001:2015, with continuous improvement initiatives to maintain excellence in product quality and process reliability.
Regulatory Compliance
Rabenac is manufactured in full compliance with Good Manufacturing Practices (GMP), WHO guidelines, and international regulatory frameworks, including FDA, EMA, and PIC/S standards. Our facility holds certifications for ISO 9001:2015 and ISO 14001:2015, ensuring environmental and quality management system excellence. All production processes are validated to meet pharmacopeial requirements, with documentation aligned with ICH and FDA regulations. Regular audits by regulatory authorities and third-party inspectors confirm ongoing compliance, enabling seamless export to markets worldwide. Our commitment to regulatory adherence ensures that Rabenac meets the stringent requirements of pharmaceutical buyers seeking reliable, compliant supply chains.
Global Supply Capability
We provide robust global supply capabilities, including bulk supply, international distribution networks, and export-ready logistics solutions. Our facility is equipped to handle large-scale production, with storage facilities optimized for temperature-controlled environments to preserve product integrity. A dedicated export team manages customs documentation, regulatory clearances, and shipping logistics, ensuring timely delivery to over 50 countries. Bulk supply capacity is supported by automated packaging systems and inventory management tools, enabling consistent supply chain reliability. Strategic partnerships with global logistics providers ensure compliance with international shipping standards, while real-time tracking systems enhance transparency for pharmaceutical exporters and distributors.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers select us for our expertise in high-quality combination drug production, regulatory compliance, and scalable manufacturing solutions. Our facility’s adherence to cGMP, ISO standards, and global regulatory frameworks ensures product reliability for international markets. With a proven track record in bulk supply and export capabilities, we offer competitive pricing without compromising on quality. Our team provides tailored support for customization, from formulation adjustments to packaging specifications, ensuring alignment with client requirements. Additionally, our commitment to innovation and continuous improvement positions us as a trusted partner for B2B buyers seeking dependable, compliant pharmaceutical solutions.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com. Our dedicated sales and technical support team is ready to assist with order placement, customization, and logistics coordination for global pharmaceutical buyers.
FAQs
What is the manufacturing process for Rabenac?
Rabenac is produced using advanced tablet compression and coating technologies, ensuring uniformity, stability, and compliance with cGMP standards.
Can Rabenac be customized for different packaging formats?
Yes, we offer flexible packaging solutions, including Alu Alu blister packs, to meet specific client requirements for bulk supply and distribution.
Does Rabenac comply with WHO and FDA regulations?
Yes, Rabenac is manufactured in full compliance with WHO guidelines, FDA regulations, and international pharmacopeial standards.
What quality control measures are in place for Rabenac?
Each batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial analysis, to ensure product consistency and safety.
Can Rabenac be produced in larger quantities for bulk supply?
Absolutely. Our facility is equipped for scalable production, supporting bulk supply to meet global demand.
What certifications does your facility hold?
Our facility is certified under ISO 9001:2015, ISO 14001:2015, and adheres to cGMP and WHO standards.
How does your export process work?
We manage end-to-end export logistics, including customs documentation, regulatory clearances, and international shipping for seamless global distribution.
Can Rabenac be produced as a private label product?
Yes, we offer private label manufacturing services, allowing clients to brand Rabenac under their own trademarks.
What is the shelf life of Rabenac in Alu Alu packaging?
Rabenac in Alu Alu packaging has a shelf life of up to 24 months when stored under recommended conditions.
How can I request a bulk supply of Rabenac?
Contact us at **info@delwishealthcare.com** for detailed inquiries, pricing, and supply arrangements for bulk orders.
