Trocal D is a dual-ingredient formulation combining calcium carbonate (500mg) in an Oyester shell with vitamin D3 (250 IU) in a compressed tablet form. The Oyester shell provides a controlled-release mechanism, ensuring gradual calcium release for optimal bioavailability. The tablet formulation is designed for stability under standard storage conditions, with minimal degradation of active ingredients. The combination of calcium carbonate and vitamin D3 is critical for maintaining bone mineral density and supporting metabolic processes, making it a key component in pharmaceutical formulations for dietary supplementation. From a manufacturing perspective, the product is produced using high-speed tablet compression techniques, ensuring uniformity in tablet weight, hardness, and disintegration time. The excipients used in the formulation are selected for their compatibility with active pharmaceutical ingredients (APIs) and their ability to meet regulatory requirements for pharmaceutical quality. The formulation’s stability profile is validated through accelerated stress testing, ensuring compliance with international pharmacopeial standards.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The facility includes a dedicated tablet compression line for producing Trocal D, featuring automated powder handling, tablet compression, and packaging systems. Sterile processing capabilities are available for critical components, ensuring contamination-free production. The manufacturing process adheres to strict quality control protocols, including in-process testing for tablet disintegration, dissolution, and content uniformity. Scalability is achieved through modular production lines capable of handling bulk orders for global distribution. The facility also supports customization for private-label manufacturing, enabling pharmaceutical buyers to meet specific market requirements. Quality systems are integrated throughout the production lifecycle, with real-time monitoring and data integrity protocols to ensure compliance with regulatory frameworks.
Available Strengths and Packaging
Trocal D is available in a single strength: Calcium Carbonate 500mg (Oyester shell) + Vitamin D3 250 IU. The product is packaged in 10x15 blister packs, designed for secure storage and efficient distribution. The blister format provides protection against moisture and physical damage, ensuring product integrity during transportation and shelf life. This packaging is ideal for pharmaceutical suppliers requiring standardized, ready-to-distribute units for retail or institutional use.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our private-label manufacturing capabilities allow clients to produce branded products under their own specifications, with full compliance to global regulatory standards. We support customization of dosage forms, packaging, and labeling to meet regional market requirements. For bulk supply, we provide scalable production solutions, ensuring consistent quality and timely delivery. Our team collaborates closely with clients to optimize formulation parameters, ensuring compliance with pharmacopeial standards and regulatory guidelines. This flexibility makes us a preferred partner for manufacturers seeking to expand their product portfolios or enter new markets.
Quality Assurance
Quality assurance at Delwis Healthcare is built on rigorous analytical validation and batch testing protocols. Each production batch undergoes comprehensive testing for active ingredient content, disintegration time, and dissolution rate using high-performance liquid chromatography (HPLC) and UV spectrophotometry. In-process controls ensure consistency in tablet hardness, weight, and thickness, while final product testing confirms compliance with pharmacopeial monographs. We maintain detailed batch records and traceability systems to support regulatory audits. Our quality control laboratory is equipped with advanced analytical instruments, including dissolution apparatus and moisture analyzers, to ensure product stability and efficacy. All quality systems are aligned with ISO 9001 and cGMP requirements, ensuring reliability for pharmaceutical buyers.
Regulatory Compliance
Delwis Healthcare complies with global regulatory frameworks, including WHO guidelines, FDA regulations, and EU GMP standards. Our manufacturing processes adhere to ICH guidelines for pharmaceutical quality, ensuring products meet international safety and efficacy criteria. The facility is certified under ISO 9001 and ISO 14001 for quality management and environmental sustainability. We maintain documentation for regulatory submissions, including stability data, analytical reports, and batch records, to support export to markets such as the US, EU, and Asia. Compliance with Good Distribution Practices (GDP) ensures secure supply chain management, while adherence to pharmacopeial standards guarantees product consistency.
Global Supply Capability
Delwis Healthcare has a robust global supply chain with capabilities for exporting to over 50 countries. Our international distribution network includes partnerships with logistics providers specializing in pharmaceuticals, ensuring timely and secure delivery. Bulk supply capacity is supported by a dedicated warehouse and inventory management system, enabling large-scale orders without compromising quality. We prioritize supply chain reliability through real-time tracking, contingency planning, and compliance with international shipping regulations. Our export services include documentation for customs clearance, ensuring seamless cross-border transactions. This infrastructure positions us as a trusted supplier for pharmaceutical buyers requiring consistent, high-quality product availability.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from Delwis Healthcare’s commitment to quality, compliance, and scalability. Our cGMP-certified facilities ensure product consistency, while our global supply chain guarantees reliable delivery to international markets. As a trusted manufacturer and supplier, we offer competitive pricing, flexible production options, and dedicated support for regulatory submissions. Our expertise in third-party manufacturing and bulk supply enables clients to meet market demands efficiently. With a focus on innovation and compliance, Delwis Healthcare delivers value-driven solutions for pharmaceutical buyers seeking reliable, high-quality products.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply capabilities for Trocal D, tailored to meet the needs of pharmaceutical manufacturers and distributors. For inquiries regarding bulk orders, please contact us at info@delwishealthcare.com.
FAQs
What certifications does Delwis Healthcare hold for manufacturing Trocal D?
Our facility is certified under cGMP, ISO 9001, and ISO 14001, ensuring compliance with global pharmaceutical standards.
Can Trocal D be produced in different packaging formats?
Yes, we offer customization for packaging, including blister packs, bottles, and cartons, to meet specific market requirements.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be discussed based on production capacity and client needs.
Does Delwis Healthcare support private-label manufacturing?
Yes, we provide private-label manufacturing services, allowing clients to brand products under their own specifications.
What quality control measures are in place for Trocal D?
Each batch undergoes rigorous testing for active ingredient content, dissolution, and stability, with full documentation for regulatory compliance.
Can Trocal D be exported to the EU and US markets?
Yes, our products comply with FDA, EU GMP, and WHO guidelines, enabling seamless export to these regions.
What is the shelf life of Trocal D in blister packaging?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
How does Delwis Healthcare ensure supply chain reliability?
We maintain a robust logistics network with real-time tracking, contingency planning, and compliance with international shipping regulations.
Can Trocal D be produced in different strengths?
Currently, Trocal D is available in a single strength (500mg calcium carbonate + 250 IU vitamin D3). Custom formulations can be discussed.
What support is available for regulatory submissions?
Our team provides documentation and technical support for regulatory submissions, including stability data and analytical reports.
