D-TRB is a multi-ingredient tablet formulation designed to combine therapeutic agents with complementary pharmacological actions. The formulation integrates Diclofenac Potassium, a nonsteroidal anti-inflammatory drug (NSAID), with Trypsin and Bromelain, proteolytic enzymes known for their anti-inflammatory and tissue-degrading properties, and Rutoside Trihydrate, a flavonoid with antioxidant and vascular strengthening effects. The tablet’s composition is optimized for stability, uniformity, and bioavailability, with excipients such as microcrystalline cellulose, magnesium stearate, and hydroxypropyl methylcellulose ensuring proper disintegration, flow, and tablet hardness. The formulation adheres to pharmaceutical standards for compatibility, with each active ingredient carefully balanced to maintain efficacy and safety during storage and handling. The final product is a robust, disintegrating tablet with a smooth coating that ensures consistent release of active components.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce D-TRB with advanced facilities compliant with cGMP standards. The facility includes state-of-the-art tablet compression, coating, and packaging lines capable of handling high-volume production while maintaining precision in dosage uniformity and tablet integrity. Sterile processing capabilities are available for critical components, ensuring contamination-free manufacturing. The production process incorporates automated systems for blending, granulation, and compression, with real-time monitoring to ensure quality control. Scalability is achieved through modular production lines that can adjust to varying order sizes, from small batches to bulk supply. Quality systems include validated cleaning protocols, environmental monitoring, and traceability mechanisms to ensure consistency and compliance.
Available Strengths and Packaging
Composition: Diclofenac Potassium 50mg + Trypsin 48mg + Bromelain 90mg + Rutoside Trihydrate 100mg Tab.
Packaging: 10x1x10 Alu Alu
D-TRB is available in a single dosage strength, with tablets packaged in 10x1x10 aluminum blister packs. The Alu Alu packaging provides moisture resistance, tamper-evidence, and light protection, ensuring product stability during storage and transportation. The blister format is ideal for retail and institutional use, with clear labeling for regulatory compliance.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing, private label, and third-party manufacturing services tailored to pharmaceutical buyers. Our capabilities include API sourcing, formulation development, and full-scale production of multi-ingredient tablets like D-TRB. We support clients in meeting regional and global regulatory requirements while maintaining flexibility in dosage forms, packaging, and labeling. Our team provides end-to-end solutions, from pre-formulation studies to finished product delivery, ensuring alignment with client specifications. This service is ideal for manufacturers seeking to expand their portfolio or enter new markets without in-house production capabilities.
Quality Assurance
Quality assurance for D-TRB is enforced through rigorous control systems, including in-process testing, batch validation, and analytical verification. Each production batch undergoes testing for dissolution, disintegration, hardness, and content uniformity using HPLC and UV spectrophotometry. Microbial testing, heavy metal analysis, and dissolution profiling ensure compliance with pharmacopeial standards. Documentation includes batch records, stability data, and deviation reports, supporting regulatory audits. Analytical validation ensures method accuracy, precision, and reproducibility, while continuous improvement programs maintain high-quality benchmarks.
Regulatory Compliance
Delwis Healthcare adheres to global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001:2015 standards. Our manufacturing processes comply with ICH, USP, and EP guidelines, ensuring product quality and safety for international markets. Regulatory submissions are supported by detailed documentation, including stability data, process validation, and compliance reports. Certifications such as ISO 9001 and GMP compliance demonstrate our commitment to meeting stringent quality and safety requirements. This ensures seamless approval processes in regions like the EU, US, and Asia-Pacific.
Global Supply Capability
Delwis Healthcare delivers bulk supply capabilities with a robust international distribution network, supporting exports to over 50 countries. Our logistics partners ensure timely delivery through air, sea, and land routes, with customs clearance and documentation assistance for seamless cross-border trade. Bulk supply capacity is scalable, accommodating large orders while maintaining consistency in quality and delivery timelines. Supply chain reliability is ensured through redundant systems, inventory management, and real-time tracking, minimizing disruptions. This infrastructure supports pharmaceutical buyers seeking reliable, long-term supply solutions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from Delwis Healthcare’s expertise in multi-ingredient tablet production. Our strengths include compliance with global standards, scalable manufacturing, and tailored solutions for diverse markets. We offer technical support, regulatory guidance, and competitive pricing to enhance client competitiveness. With a focus on innovation and quality, we provide end-to-end services that streamline supply chain operations and ensure market readiness.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply capabilities for D-TRB. For inquiries, contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delwis Healthcare follow for D-TRB?
Our production adheres to cGMP, WHO, and ISO 9001:2015 standards, ensuring compliance with global regulatory requirements.
Can D-TRB be produced in different packaging formats?
While D-TRB is currently available in 10x1x10 Alu Alu blister packs, we can customize packaging based on client specifications.
What quality control measures are in place for D-TRB?
Each batch undergoes dissolution testing, microbial analysis, and HPLC validation to ensure consistency and safety.
Is Delwis Healthcare certified for international exports?
Yes, we hold ISO 9001 and GMP certifications, enabling seamless exports to regions like the EU, US, and Asia-Pacific.
How does Delwis Healthcare ensure supply chain reliability?
Our logistics network, combined with real-time tracking and inventory management, ensures timely and consistent deliveries.
Can D-TRB be manufactured in smaller batch sizes?
Yes, our scalable production lines accommodate both small and large-scale orders without compromising quality.
What regulatory documentation is provided with D-TRB?
We supply batch records, stability data, and compliance reports to support regulatory submissions and audits.
How does Delwis Healthcare support contract manufacturing partners?
We offer end-to-end solutions, including formulation development, API sourcing, and finished product delivery, tailored to client needs.
What is the shelf life of D-TRB?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data provided upon request.
Can Delwis Healthcare assist with regulatory approvals for D-TRB?
Yes, our team provides regulatory guidance and documentation support to facilitate approvals in target markets.
