Delom - D is a fixed-dose combination tablet formulated with Omeprazole 20mg and Domperidone 10mg, designed for optimal therapeutic efficacy and stability. The formulation incorporates Omeprazole, a benzimidazole derivative, as the proton pump inhibitor (PPI), and Domperidone, a dopamine receptor antagonist, as the prokinetic agent. The tablet is compressed into a caplet form using high-quality excipients, including a disintegrant, binder, and lubricant, to ensure uniformity, stability, and controlled release. The manufacturing process ensures the compatibility of the two active ingredients, which are chemically stable under standard storage conditions. The formulation is designed to withstand pH variations and osmotic stress, ensuring consistent dissolution rates and bioavailability. The caplet’s physical properties, such as hardness, friability, and disintegration time, are meticulously controlled to meet pharmaceutical specifications. The combination of Omeprazole and Domperidone in a single dosage form simplifies administration while maintaining the therapeutic synergy between the two compounds.
Manufacturing Capability
Delom - D is manufactured using state-of-the-art pharmaceutical infrastructure, including automated tablet compression lines, high-speed coating systems, and advanced quality control laboratories. The production facility is equipped with sterile processing capabilities to ensure contamination-free manufacturing, particularly for critical components like Omeprazole, which requires controlled environmental conditions. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains rigorous quality systems, including validation of equipment, process control, and documentation of all manufacturing steps. The production process is scalable to meet bulk supply demands, with the capability to produce large quantities while maintaining consistent product quality. The facility’s quality assurance systems include real-time monitoring of critical parameters such as temperature, humidity, and pressure during tablet compression and packaging. Additionally, the infrastructure supports customization for different packaging formats and dosage strengths, ensuring flexibility for pharmaceutical buyers.
Available Strengths and Packaging
Composition: Omeprazole 20mg + Domperidone 10mg Cap
Packaging: 10x10 Strip
Delom - D is available in a standardized dosage form of 20mg Omeprazole combined with 10mg Domperidone in a caplet format. The packaging is provided in a 10x10 strip, ensuring convenient storage and distribution for pharmaceutical manufacturers and 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 private label manufacturing capabilities allow clients to produce branded formulations under their own brand names, while our contract manufacturing services ensure compliance with global regulatory standards. We specialize in producing high-quality, cost-effective solutions for both domestic and international markets. Our team of experts provides end-to-end support, from formulation development to packaging and labeling, ensuring seamless integration into clients’ supply chains. Whether you require small-scale pilot batches or large-volume production, our scalable infrastructure and flexible manufacturing processes enable us to meet diverse requirements.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of product consistency, safety, and efficacy. Every batch of Delom - D undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to confirm drug release profiles, and microbial limit testing to ensure sterility. Analytical validation of the formulation is conducted to verify stability, purity, and potency under various storage conditions. Our quality control protocols comply with international pharmaceutical standards, including ICH guidelines and FDA regulations, ensuring that all products meet the required specifications for pharmaceutical use. Detailed documentation and traceability systems are maintained to support audits and regulatory inspections.
Regulatory Compliance
Delom - D is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our facility is certified for export to major pharmaceutical markets, including the EU, US, and Asia, ensuring adherence to regional regulatory frameworks. The product is formulated and produced in accordance with global pharmacopeial standards, including USP, EP, and BP, to guarantee consistency and quality. Our regulatory compliance team ensures that all documentation, including batch records, stability data, and safety assessments, meets the requirements of international regulatory bodies. This ensures that Delom - D is suitable for global distribution and meets the stringent quality expectations of pharmaceutical buyers.
Global Supply Capability
We provide robust global supply capabilities, including export-ready manufacturing, international distribution networks, and bulk supply options to meet the demands of pharmaceutical distributors and exporters. Our logistics partners ensure timely delivery to over 50 countries, with reliable supply chain solutions to support both short-term and long-term contracts. The facility’s bulk production capacity allows for large-scale manufacturing, ensuring consistent supply without compromising quality. Our supply chain reliability is further enhanced by real-time inventory tracking, compliance with international shipping regulations, and adherence to pharma logistics best practices. Whether you require small or large-volume orders, our infrastructure and global reach ensure seamless delivery to your market.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our commitment to quality, compliance, and scalability. Our expertise in producing high-standard pharmaceutical products ensures that Delom - D meets the rigorous demands of global markets. With a proven track record of regulatory compliance and a focus on innovation, we deliver reliable, cost-effective solutions tailored to your business needs. Our dedicated team provides end-to-end support, from manufacturing to supply chain management, ensuring that your operations run smoothly. By partnering with us, you gain access to a trusted manufacturer with the capacity to scale, the expertise to navigate complex regulations, and the reliability to meet your bulk supply requirements.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com. Our team is ready to assist with customized solutions, including packaging specifications, regulatory documentation, and supply chain logistics.
FAQs
What manufacturing standards does Delom - D comply with?
Delom - D is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001:2015 standards, ensuring adherence to global pharmaceutical regulations.
Can Delom - D be produced in different packaging formats?
Yes, we offer flexible packaging options, including the standard 10x10 strip, to meet the specific needs of pharmaceutical buyers.
What is the shelf life of Delom - D?
Delom - D has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from moisture).
Does your facility support third-party manufacturing?
Yes, we provide third-party manufacturing services, including private label and contract manufacturing, to meet the needs of global pharmaceutical buyers.
What quality control tests are performed on Delom - D?
We conduct HPLC analysis, dissolution testing, microbial limit testing, and stability studies to ensure product quality and compliance.
Can you supply Delom - D for export to specific regions?
Yes, our global supply network enables export to over 50 countries, with compliance tailored to regional regulatory requirements.
What is the minimum order quantity for bulk supply?
We accommodate both small and large orders, with flexible minimum quantities based on your production needs.
How do you ensure supply chain reliability?
Our logistics partners and real-time inventory tracking systems ensure timely delivery and supply chain reliability for all orders.
Can you provide documentation for regulatory approvals?
Yes, we supply complete regulatory documentation, including batch records, stability data, and compliance certificates.
How can I request a sample or bulk supply?
Contact our sales team at **info@delwishealthcare.com** for sample requests or to discuss bulk supply options.
