TRB Plus is a meticulously formulated pharmaceutical tablet combining Trypsin (48mg), Bromelain (90mg), and Rutoside Trihydrate (100mg) in a stable, bioavailable matrix. The formulation leverages advanced excipient compatibility testing to ensure optimal dissolution rates and stability during storage. Trypsin, a proteolytic enzyme, and Bromelain, a cysteine protease, are sourced from purified biological origins, while Rutoside Trihydrate, a flavonoid derivative, is incorporated to enhance vascular integrity. The tablet’s disintegration and dissolution profiles are optimized for rapid release, ensuring consistent pharmacokinetic behavior. The formulation process involves controlled blending, compression, and coating techniques to maintain the integrity of thermolabile and enzymatic components. The excipients used, including magnesium stearate and microcrystalline cellulose, are selected for their compatibility with the active pharmaceutical ingredients (APIs) and their ability to support tablet hardness, flowability, and moisture resistance. The final product adheres to strict physicochemical specifications, including pH neutrality, disintegration time, and dissolution efficiency, ensuring suitability for pharmaceutical applications requiring enzymatic and vascular activity.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is designed to handle complex formulations like TRB Plus with precision and scalability. The facility is equipped with state-of-the-art tablet compression machines, high-speed mixers, and advanced coating systems to ensure uniformity in dosage form. Sterile processing capabilities are maintained through ISO Class 7 cleanrooms, with dedicated equipment for aseptic filling and packaging. All manufacturing processes comply with current Good Manufacturing Practices (cGMP), ensuring adherence to international quality standards. The production line supports batch sizes ranging from small-scale trials to large-volume commercial runs, with a focus on maintaining consistency in API content and excipient homogeneity. Quality systems include real-time monitoring of critical process parameters, such as temperature, humidity, and compression force, to prevent deviations that could compromise product integrity. The facility’s robust validation protocols and documented procedures ensure reproducibility and traceability, making it ideal for manufacturers seeking reliable, scalable production of enzymatic and flavonoid-based formulations.
Available Strengths and Packaging
Composition: Trypsin 48mg + Bromelain 90mg + Rutoside Trihydrate 100mg Tab.
Packaging: 10x1x10 Alu Alu
TRB Plus is available in a standardized dosage form of 48mg Trypsin, 90mg Bromelain, and 100mg Rutoside Trihydrate per tablet. The packaging consists of a 10x1x10 aluminum blister pack, designed for secure storage and extended shelf life. The aluminum blister format provides protection against moisture, light, and atmospheric degradation, ensuring product stability during transportation and storage. This packaging configuration is ideal for pharmaceutical suppliers requiring controlled distribution and compliance with regulatory packaging standards.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of pharmaceutical buyers. Our facility supports private label manufacturing, enabling clients to produce high-quality products under their brand while leveraging our expertise in formulation development and regulatory compliance. We specialize in producing complex combinations like TRB Plus, with the flexibility to adjust dosages, packaging formats, and production scales to meet specific market demands. Our team of pharmacists and engineers collaborates closely with clients to ensure alignment with their quality control protocols and labeling requirements. Whether you are a distributor seeking to expand your portfolio or an exporter looking to enter new markets, our contract manufacturing capabilities provide a scalable, cost-effective solution for producing pharmaceutical-grade products that meet global standards.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Every batch of TRB Plus undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing to confirm release profiles, and microbial limit testing to ensure sterility. In-process controls monitor critical parameters such as tablet hardness, disintegration time, and content uniformity, while finished product inspections verify compliance with pharmacopoeial monographs. We maintain detailed batch records and employ advanced data integrity systems to ensure traceability and transparency. Our quality control team adheres to ICH and USP guidelines, ensuring that TRB Plus meets the stringent requirements of regulatory authorities worldwide. This commitment to excellence positions us as a reliable partner for manufacturers prioritizing product consistency and safety.
Regulatory Compliance
TRB Plus 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 routinely audited by regulatory bodies and maintains certifications that align with the requirements of the FDA, EMA, and other global regulatory frameworks. The product’s formulation, labeling, and packaging are designed to meet the specifications of international pharmacopoeias, including the United States Pharmacopeia (USP) and European Pharmacopoeia (EP). We ensure that all documentation, including batch records, stability data, and regulatory submissions, is prepared in accordance with applicable laws, enabling seamless approval processes for global markets. This regulatory alignment enhances the product’s viability for export and ensures compliance with the stringent requirements of pharmaceutical buyers worldwide.
Global Supply Capability
We provide robust global supply capabilities, including bulk export, international distribution networks, and reliable supply chain logistics. Our facility is strategically positioned to support large-volume orders, with the capacity to fulfill both regional and global demand. We partner with trusted logistics providers to ensure timely delivery to key markets, including Asia, Europe, and the Americas. Our bulk supply capacity is supported by automated inventory management systems, enabling real-time tracking of stock levels and order fulfillment. We prioritize supply chain reliability through contingency planning, redundant manufacturing lines, and supplier diversification, ensuring uninterrupted delivery even in challenging market conditions. This infrastructure makes us an ideal partner for exporters and distributors seeking dependable, scalable solutions for pharmaceutical products.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our combination of expertise, compliance, and scalability. Our facility’s adherence to cGMP, WHO, and ISO standards ensures that TRB Plus meets the highest quality benchmarks, reducing regulatory risks for buyers. The ability to produce complex formulations like TRB Plus with consistent quality and flexibility in packaging options enhances our appeal to global markets. Our commitment to transparency, coupled with a proven track record of reliable bulk supply, positions us as a trusted partner for businesses seeking to expand their product portfolios. By leveraging our manufacturing capabilities and regulatory expertise, clients can achieve cost-effective, high-quality solutions that align with their business objectives.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical manufacturers, distributors, and exporters seeking reliable, high-quality products.
FAQs
What manufacturing standards does TRB Plus adhere to?
TRB Plus is produced in compliance with cGMP, WHO guidelines, and ISO 9001:2015 standards, ensuring quality and consistency for global markets.
Can TRB Plus be customized for specific packaging requirements?
Yes, we offer flexible packaging solutions, including the 10x1x10 Alu Alu format, and can accommodate custom labeling and dosage adjustments.
What is the shelf life of TRB Plus?
TRB Plus has a shelf life of 24 months when stored under recommended conditions, as confirmed by stability testing.
Does your facility support sterile manufacturing processes?
Yes, our facility includes ISO Class 7 cleanrooms and aseptic processing capabilities for sensitive formulations.
Can TRB Plus be produced in larger quantities for bulk supply?
Absolutely. Our production infrastructure supports scalable manufacturing, with the ability to meet large-volume bulk supply demands.
What quality control measures are in place for TRB Plus?
Each batch undergoes rigorous testing, including HPLC, dissolution, and microbial limit tests, ensuring compliance with pharmacopoeial standards.
Are there options for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand TRB Plus under their own label.
What regulatory approvals are required for exporting TRB Plus?
TRB Plus is compliant with FDA, EMA, and WHO guidelines, enabling seamless export to international markets.
How do you ensure supply chain reliability?
We maintain redundant manufacturing lines, automated inventory systems, and partnerships with global logistics providers to ensure uninterrupted supply.
Can I request a sample of TRB Plus for evaluation?
Yes, we provide samples upon request to support quality evaluation and market testing.
