Calwis XT is a meticulously formulated multivitamin tablet designed for pharmaceutical manufacturers requiring a high-potency, stable, and scalable product. The formulation integrates Calcium Carbonate (1250mg) as a calcium source, Vitamin D3 (2000IU) for bone health, Methylcobalamin (1500mcg) as an active form of vitamin B12, L-Methyl Folate Calcium (1mg) for folate metabolism, and Pyridoxal-5-phosphate (20mg) as the active form of vitamin B6. These ingredients are combined using advanced excipient compatibility testing to ensure stability, uniformity, and optimal dissolution rates. The formulation employs a direct compression method, leveraging excipients such as microcrystalline cellulose and magnesium stearate to achieve consistent tablet hardness, disintegration time, and content uniformity. The combination of fat-soluble and water-soluble components is optimized to prevent degradation during storage, with a pH-adjusted matrix to enhance chemical stability. The final product meets stringent pharmaceutical standards for potency, purity, and physicochemical properties, ensuring suitability for global markets.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production line includes high-speed tablet compression machines, advanced blending systems, and automated packaging units capable of handling complex formulations like Calwis XT. Sterile processing capabilities are available through ISO Class 7 cleanrooms for critical components, ensuring contamination-free environments for sensitive ingredients. The facility supports scalable production, with the ability to adjust output from small batches to large-scale commercial runs while maintaining consistent quality. Quality systems include real-time monitoring of critical parameters such as tablet weight, disintegration time, and dissolution efficiency. Additionally, the infrastructure is designed for flexibility, enabling customization of excipient ratios, coating technologies, and packaging formats to meet diverse market demands.
Available Strengths and Packaging
Calwis XT is available in a single strength: Calcium Carbonate 1250mg + Vitamin D3 2000IU + Methylcobalamin 1500mcg + L-Methyl Folate Calcium 1mg + Pyridoxal-5-phosphate 20mg Tablets. The product is packaged in a 10x15 blister format, ensuring tamper-evident protection, moisture resistance, and compliance with pharmaceutical packaging standards. The blister pack design facilitates efficient storage, transportation, and retail display, with a focus on consumer convenience and regulatory compliance.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own trademarks, with full customization of formulation, packaging, and labeling. We support contract manufacturing for both domestic and international markets, ensuring adherence to local regulations and quality standards. Our team provides end-to-end solutions, from raw material sourcing to final product packaging, with transparent documentation and traceability. This flexibility enables pharmaceutical companies to streamline supply chains, reduce time-to-market, and maintain competitive advantages in global markets.
Quality Assurance
Quality assurance is a cornerstone of our manufacturing process, with rigorous control systems ensuring compliance with pharmaceutical standards. Each batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for potency verification, UV spectrophotometry for impurity detection, and dissolution testing to confirm bioavailability. Analytical validation protocols are aligned with USP, EP, and BP guidelines, ensuring accuracy and reproducibility. In-process controls monitor critical parameters such as tablet hardness, friability, and disintegration time, while final product testing confirms compliance with specifications for identity, purity, and stability. Our quality systems are designed to meet the demands of regulatory audits and ensure consistent product quality for global distribution.
Regulatory Compliance
Our operations are fully compliant with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international ISO standards (ISO 9001, ISO 14001). We adhere to regulatory frameworks such as the FDA’s Current Good Manufacturing Practice (CGMP) for finished pharmaceuticals, the European Medicines Agency (EMA) guidelines, and the ICH Q7 for active pharmaceutical ingredients. Our facilities are regularly audited by third-party regulatory bodies and certification agencies to maintain compliance with global standards. This ensures that Calwis XT meets the requirements for export to markets in the EU, Asia, Africa, and the Americas, with documentation ready for regulatory submissions.
Global Supply Capability
We provide robust global supply capabilities, including bulk export, international distribution networks, and reliable supply chain logistics. Our export infrastructure supports seamless delivery to over 50 countries, with partnerships in key regions such as North America, Europe, Asia-Pacific, and Africa. Bulk supply capacity is optimized for large-scale pharmaceutical buyers, with storage facilities equipped to handle high-volume orders. Our supply chain is designed for resilience, incorporating dual sourcing of raw materials, real-time inventory tracking, and contingency planning to ensure uninterrupted delivery. This ensures that clients receive consistent, high-quality products without delays, regardless of market conditions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, scalable products like Calwis XT. Our commitment to compliance, innovation, and reliability positions us as a trusted partner for global markets. With a proven track record in manufacturing complex formulations, we offer competitive pricing, rapid turnaround times, and full transparency in production. Our ability to meet stringent regulatory requirements and adapt to evolving market needs ensures long-term collaboration and customer satisfaction.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical buyers seeking reliable, high-quality products.
FAQs
What manufacturing standards does Calwis XT comply with?
Calwis XT is manufactured in compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical standards.
Can Calwis XT be produced in different packaging formats?
Yes, we offer flexibility in packaging, including blister packs, bottles, and blister strips, to meet diverse market requirements.
What is the shelf life of Calwis XT?
Calwis XT has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Does your facility support sterile manufacturing?
Yes, our ISO Class 7 cleanrooms ensure sterile processing for sensitive ingredients, meeting GMP requirements.
Can you provide documentation for regulatory submissions?
Absolutely. We supply complete documentation, including batch certificates, stability data, and regulatory compliance reports.
What is the minimum order quantity for bulk supply?
We accommodate both small and large orders, with minimum quantities tailored to client specifications.
How do you ensure product consistency across batches?
Our quality control systems, including HPLC and dissolution testing, ensure consistent potency, purity, and quality across all batches.
Can you assist with private label manufacturing?
Yes, we offer private label solutions, allowing clients to brand products under their own trademarks.
What regions do you export to?
We export to over 50 countries, including the EU, Asia-Pacific, Africa, and the Americas, with compliance for local regulations.
How do you handle supply chain disruptions?
Our supply chain includes dual sourcing, real-time tracking, and contingency planning to ensure uninterrupted delivery.
