Rabacid - DSR is a fixed-dose combination tablet formulated with Rabeprazole 20mg and Domperidone 30mg in a sustained-release (SR) capsule format. The formulation leverages advanced excipient compatibility to ensure stability and uniformity in the combined dosage form. Rabeprazole, a proton pump inhibitor (PPI), is incorporated into a matrix that ensures rapid dissolution for immediate acid suppression, while Domperidone SR is formulated using a controlled-release technology to maintain therapeutic levels over an extended period. The SR capsule design enhances patient compliance by reducing the frequency of dosing. The product’s composition is optimized for pharmaceutical robustness, with excipients selected to prevent degradation under varied storage conditions. The manufacturing process ensures precise blending, compression, and coating techniques to maintain the integrity of both active ingredients, ensuring consistent potency and bioavailability.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The facility includes advanced tablet compression lines, coating systems, and sterile processing units capable of handling complex formulations like Rabacid - DSR. The SR capsule formulation is produced using a specialized controlled-release technology, ensuring uniform drug release profiles. The manufacturing process adheres to strict quality control protocols, including in-process testing for moisture content, dissolution rates, and tablet hardness. The facility supports scalable production, enabling seamless transition from small batches to bulk supply while maintaining consistency in product quality. Comprehensive quality systems, including traceability and documentation, ensure full compliance with regulatory requirements and facilitate audits.
Available Strengths and Packaging
Composition: Rabeprazole 20mg + Domperidone 30mg SR Cap
Packaging: 10x10 Alu Alu
Rabacid - DSR is available in a single strength combination of Rabeprazole 20mg and Domperidone 30mg SR Cap. The 10x10 Alu Alu packaging provides a robust, moisture-resistant barrier, ensuring product stability during storage and transportation. This blister pack format offers enhanced tamper-evidence and light protection, making it ideal for both domestic and international distribution. The packaging is designed for efficient bulk handling, with each box containing 10 individual blister packs, ensuring ease of logistics and supply chain management.
Contract Manufacturing / Third Party Manufacturing
As a leading manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our facility is equipped to produce Rabacid - DSR under the client’s brand name, ensuring full customization in packaging, labeling, and regulatory documentation. We support global clients by adhering to international standards such as WHO GMP and FDA guidelines, enabling seamless market entry. Our contract manufacturing capabilities include flexibility in production scales, from small trial batches to large-volume bulk supply. Additionally, we provide end-to-end solutions for packaging, labeling, and regulatory compliance, ensuring clients meet all market-specific requirements.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Each batch of Rabacid - DSR undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for potency confirmation, dissolution testing to validate SR release profiles, and impurity analysis to ensure safety. In-process controls monitor critical parameters such as tablet weight, disintegration time, and coating uniformity. The product is also tested for microbial contamination, heavy metals, and particulate matter to meet global regulatory benchmarks. Our quality systems are ISO 9001-certified, ensuring continuous improvement and compliance with cGMP requirements.
Regulatory Compliance
Rabacid - DSR is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001 standards. Our facility maintains documentation for all regulatory audits, including batch records, stability data, and validation reports. The product meets the requirements of the FDA, EMA, and other global regulatory bodies, enabling smooth export to international markets. We ensure compliance with ICH guidelines for analytical methods and pharmacopeial standards for active pharmaceutical ingredients (APIs). Our regulatory team provides support for dossier preparation, including technical documents for market authorization and labeling compliance.
Global Supply Capability
We offer robust global supply capabilities, including bulk supply options for pharmaceutical exporters and distributors. Our logistics network spans major markets, with partnerships for efficient international distribution. The 10x10 Alu Alu packaging is optimized for bulk handling, ensuring cost-effective transportation and storage. Our supply chain is designed for reliability, with redundant systems to mitigate disruptions and maintain consistent delivery timelines. We support both short-term orders and long-term contracts, with the flexibility to scale production based on demand. Our export capabilities are further enhanced by compliance with international trade regulations, ensuring seamless cross-border shipments.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant formulations like Rabacid - DSR. Our facility’s adherence to cGMP and ISO standards ensures product consistency and regulatory readiness. We offer competitive pricing without compromising on quality, supported by a dedicated team for technical and logistical support. Our scalable manufacturing capabilities and global supply network enable clients to meet market demands efficiently. With a proven track record in bulk supply and regulatory compliance, we provide a reliable partner for expanding your product portfolio.
Bulk Supply Inquiry
For bulk supply inquiries, contact our sales team at info@delwishealthcare.com to discuss customization, pricing, and logistics for Rabacid - DSR.
FAQs
What manufacturing standards does Rabacid - DSR comply with?
Rabacid - DSR is manufactured in compliance with cGMP, WHO GMP, and ISO 9001 standards, ensuring quality and regulatory readiness for global markets.
Can Rabacid - DSR be produced in different packaging formats?
Yes, we offer flexible packaging options, including the standard 10x10 Alu Alu format, and can customize packaging to meet specific client requirements.
What is the shelf life of Rabacid - DSR?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data validated through accelerated testing.
Is Rabacid - DSR suitable for export to international markets?
Yes, our regulatory compliance with FDA, EMA, and WHO guidelines ensures seamless export to global markets.
Can Rabacid - DSR be produced under a private label?
Absolutely. We offer private label manufacturing services, allowing clients to brand the product under their own name.
What quality control measures are in place for Rabacid - DSR?
Each batch undergoes rigorous testing, including HPLC, dissolution profiling, and microbial testing, to ensure compliance with pharmacopeial standards.
What is the minimum order quantity for bulk supply?
We accommodate orders starting from small trial batches, with scalable production options for bulk supply.
How does your supply chain ensure reliability?
Our supply chain is supported by redundant logistics systems, certified partners, and real-time tracking to ensure timely and consistent delivery.
Can you provide documentation for regulatory submissions?
Yes, we supply complete technical documentation, including batch records, stability data, and regulatory compliance certificates.
What is the lead time for production and delivery?
Lead times vary based on order size, but we prioritize efficient turnaround with clear timelines provided upon order confirmation.
